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Objective To investigate the craniofacial growth outcomes of early secondary alveolar bone grafting(ABG) around 6 years of age. Design Retrospective cohort study Setting 1 North-American and 5 Northern-European cleft centers. Subjects 33 subjects with CUCLP consecutively treated with secondary ABG around 6 years of age were compared to 105 subjects from 4 centers treated with late secondary ABG and 19 subjects from 1 center with primary ABG. Methods Preorthodontic standardized lateral cephalometric radiographs taken after 12 years of age were traced and analyzed according to the Eurocleft Study protocol. Fourteen angular and two proportional measurements were performed. Measurement means from the Study Center(SC) were compared to 5 Northern-European centers using analysis of variance and Welch's modified t-tests, and P Results For the SC, the mean age ± SD at the time of bone graft was 5.85 ± 0.71 years and the mean age at the time of the lateral cephalogram was 13.4 ± 1.8 years. The sagittal maxillary prominence of the SC was favorably comparable to the 5 Northern-European centers. The mean SNA (78.1 ± 4.3) for the SC was significantly higher compared to 4 of the 5 Northern-European centers(all P Conclusions Craniofacial growth outcomes of early secondary ABG around 6 years compare favorably to the outcomes of late secondary ABG.

Summary Background Previous studies embracing digital technology and automated methods of scoring dental arch relationships have shown that such technology is valid and accurate. To date, however there is no published literature on artificial intelligence and machine learning to completely automate the process of dental landmark recognition. Objectives This study aimed to develop and evaluate a fully automated system and software tool for the identification of landmarks on human teeth using geometric computing, image segmenting, and machine learning technology. Methods Two hundred and thirty-nine digital models were used in the automated landmark recognition (ALR) validation phase, 161 of which were digital models from cleft palate subjects aged 5 years. These were manually annotated to facilitate qualitative validation. Additionally, landmarks were placed on 20 adult digital models manually by 3 independent observers. The same models were subjected to scoring using the ALR software and the differences (in mm) were calculated. All the teeth from the 239 models were evaluated for correct recognition by the ALR with a breakdown to find which stages of the process caused the errors. Results The results revealed that 1526 out of 1915 teeth (79.7%) were correctly identified, and the accuracy validation gave 95% confidence intervals for the geometric mean error of [0.285, 0.317] for the humans and [0.269, 0.325] for ALR—a negligible difference. Conclusions/implications It is anticipated that ALR software tool will have applications throughout clinical dentistry and anthropology, and in research will constitute an accurate and objective tool for handling large datasets without the need for time intensive employment of experts to place landmarks manually.

Objective: Cleft palate (CP) can affect breathing, leading to sleep-disordered breathing (SDB). Sleep position can affect SDB, but the optimum sleep position for infants with CP is unknown. We aimed to determine the design of a pragmatic study to investigate the effect of the 2 routinely advised sleep positions in infants with CP on oxygen saturations. Design: A multicentered observational cohort. Setting: Four UK-based cleft centers, 2 advising supine- and 2 side-lying sleep positions for infants with CP. Participants: Infants with isolated CP born July 1, 2015, and December 31, 2016. Of 48 eligible infants, 30 consented (17 side-lying; 13 supine). Interventions: Oxygen saturation (SpO2) and end-tidal carbon dioxide (ETCO2) home monitoring at age 1 and 3 months. Qualitative interviews of parents. Outcome Measures: Willingness to participate, recruitment, retention, and acceptability/success (>90 minutes recording) of SpO2 and ETCO2 monitoring. Results: SpO2 recordings were obtained during 50 sleep sessions on 24 babies (13 side-lying) at 1 month (34 sessions >90 minutes) and 50 sessions on 19 babies (10 side-lying) at 3 months (27 sessions >90 minutes). The ETCO2 monitoring was only achieved in 12 sessions at 1 month and 6 at 3 months; only 1 was >90 minutes long. The ETCO2 monitoring was reported by the majority as unacceptable. Parents consistently reported the topic of sleep position in CP to be of importance. Conclusions: This study has demonstrated that it is feasible to perform domiciliary oxygen saturation studies in a research setting and has suggested that there may be a difference in the effects of sleep position that requires further investigation. We propose a study with randomization is indicated, comparing side-lying with supine-lying sleep position, representing an important step toward better understanding of SDB in infants with CP.

Summary Background and trial design The Scandcleft intercentre study evaluates the outcomes of four surgical protocols (common method Arm A, and methods B, C, and D) for treatment of children with unilateral cleft lip and palate (UCLP) in a set of three randomized trials of primary surgery (Trials 1, 2, and 3). Objectives To evaluate and compare dental arch relationships of 5-, 8-, and 10-year-old children with UCLP after four different protocols of primary surgery and to compare three dental indices. The results are secondary outcomes of the overall trial. Methods Study models taken at the ages of 5 (n = 418), 8 (n = 411), and 10 years (n = 410) were analysed by a blinded panel of orthodontists using the Eurocran index, the 5-year-olds’ (5YO) index, and the GOSLON Yardstick. Student’s t-test, Pearson’s correlation, chi-square test, and kappa statistics were used in statistical analyses. Results The reliability of the dental indices varied between moderate and very good, and those of the Eurocran palatal index varied between fair and very good. Significant correlations existed between the dental indices at all ages. No differences were found in the mean 5-, 8-, and 10-year index scores or their distributions within surgical trials. Comparisons between trials detected significantly better mean index scores in Trial 2 Arm C (at all ages) and in Trial 1 Arm B (at 5 and 10 years of age) than in Trial 3 Arm D. The mean Eurocran dental index scores of the total material at 5, 8, and 10 years of age were 2.50, 2.60, and 2.26, and those of the 5YO index and GOSLON Yardstick were 2.77, 2.90, and 2.54, respectively. At age 10 years, 75.8% of the patients had had orthodontic treatment. Conclusions The results of these three trials do not provide evidence that one surgical method is superior to the others. The reliabilities of the dental indices were acceptable, and significant correlations existed between the indices at all ages. The reliability of the Eurocran palatal index was questionable. Trial registration ISRCTN29932826.

Summary Background The Scandcleft trial is a randomized controlled trial that includes children with unilateral cleft lip and palate where registrations are standardized and therefore provides the opportunity to describe craniofacial characteristics in a very large sample of patients. Objectives The aim of this study was to describe craniofacial growth and morphology in a large study sample of 8-year-old children with unilateral cleft lip and palate (UCLP); before orthodontic treatment and before secondary alveolar bone grafting; and to compare the cephalometric values with age-matched non-cleft children from previous growth studies to identify the differences between untreated cleft- and non-cleft children. Materials There are 429 eight-year-old UCLP patients in the Scandcleft study group. A total of 408 lateral cephalograms with a mean age of 8.1 years were analysed. Cephalometric analyses were performed digitally. The results from three previously published growth studies on non-cleft children were used for comparison. Results Cephalometric analyses showed a large variation in craniofacial morphology among the UCLP group. In general, they present with significant maxillary retrusion and reduced intermaxillary relationships compared to the age-matched non-cleft children. In addition, the vertical jaw relationship was decreased, mainly due to decreased maxillary inclination. The upper and lower incisors were retroclined. It can be expected that these differences will increase in significance as the children age. Conclusion Results from this study provide proposed norms for the young UCLP before any orthodontic treatment and can be valuable for the clinician in future treatment planning. Trial registration ISRCTN29932826.

Background Cleft palate is among the most common birth abnormalities. The success of primary surgery in the early months of life is crucial for successful feeding, hearing, dental development, and facial growth. Over recent decades, age at palatal surgery in infancy has reduced. The Timing Of Primary Surgery for cleft palate (TOPS) trial aims to determine whether, in infants with cleft palate, it is better to perform primary surgery at age 6 or 12 months (corrected for gestational age). Methods/design The TOPS trial is an international, two-arm, parallel group, randomised controlled trial. The primary outcome is insufficient velopharyngeal function at 5 years of age. Secondary outcomes, measured at 12 months, 3 years, and 5 years of age, include measures of speech development, safety of the procedure, hearing level, middle ear function, dentofacial development, and growth. The analysis approaches for primary and secondary outcomes are described here, as are the descriptive statistics which will be reported. The TOPS protocol has been published previously. Discussion This paper provides details of the planned statistical analyses for the TOPS trial and will reduce the risk of outcome reporting bias and data-driven results. Trial registration ClinicalTrials.gov NCT00993551. Registered on 9 October 2009.

Objective: To compare the outcomes between 2 groups of patients with complete clefts treated with early secondary alveolar bone grafting (ABG) at 2 centers (5-7 years, before orthodontic intervention) and to a third group of patients treated at one of those centers (center 1) who had received later secondary ABG (8-10 years, after orthodontic intervention). Design: Blind retrospective analysis of cleft site radiographs using Americleft Standardized Way to Assess Grafts (SWAG) scale. Patients: A total of 99 patients with complete clefts from 2 North American cleft/craniofacial centers. Interventions: Secondary ABG representing 2 protocols: early grafting at a mean age of 6.6 years prior to any orthodontic intervention, and later grafting at a mean age of 10.2 years following pregrafting orthodontic intervention. Main Outcome Measures: Using occlusal radiographs, the SWAG scale from 0 (failed graft) to 6 (ideal) was used. Six trained, calibrated raters scored each radiograph twice, with the average of the 2 ratings used as the final score. Reliability was assessed using the weighted κ statistic. The significance of differences between groups was determined using the Kruskal-Wallis test and Dunn test for pairwise comparisons. Results: Inter-rater reliability of SWAG method was good (0.631). Intra-rater reliability was excellent (0.817). There was a tendency for improved total graft outcome in the early grafted group from center 1 compared to the later grafted group with improvement being significantly different in only the coronal third of the early, preorthodontic grafted group. However, the difference was not statistically significant for the graft overall.

The consequence of differing levels of agreement across raters is rarely studied. Subsequently, knowledge is limited on how number of raters affects the outcome. The present study aimed to examine the impact on pre-linguistic outcome classifications of 12-month-old infants when using four raters compared to three. Thirty experienced Speech and Language Therapists (SLTs) from five countries assessed 20 minute video recordings of four 12-month-old infants during a play session with a parent. One recording was assessed twice. A naturalistic listening method in real time was used. This involved: (1) assessing, each syllable as canonical or non-canonical, and (2) following the recording, assessing if the infant was babbling canonically and listing the syllables the infant produced with command. The impact that four raters had on outcome, compared to three, was explored by classifying the outcome based on all possible combinations of three raters and determining the frequency that the outcome assessment changed when a fourth assessor was added. Results revealed that adding a fourth rater had a minimal impact on canonical babbling ratio assessment. Presence/absence of canonical babbling and size of consonant inventory showed a negligible impact on three out of four recordings, whereas the size of syllable inventory and presence/absence of canonical babbling was minimally affected in one recording by adding a fourth rater. In conclusion, adding a forth rater in assessment of pre-linguistic utterances in 12-month-old infants with naturalistic assessment in real time does not affect outcome classifications considerably. Thus, using three raters, as opposed to four, is recommended.

Summary Background and trial design The Scandcleft intercentre study evaluates the outcomes of four surgical protocols for treatment of children with unilateral cleft lip and palate (UCLP). Originally 10 cleft centres in Denmark, Finland, Norway, Sweden, and the UK participated in a set of three randomized trials of primary surgery. Three groups of centres (Trials 1, 2, and 3) tested their traditional local surgical protocols (Arms B, C, and D) against a common protocol (Arm A). Objectives To evaluate dental arch relationships at age 8 years after four different protocols of primary surgery for UCLP. These results are secondary outcomes of the overall trial. Methods Study models of 411 children (270 boys, 141 girls) with non-syndromic UCLP at a mean age of 8.1 (range 7.0–10.0) years were available. Dental arch relationships were analysed using the GOSLON Yardstick by a blinded panel of 11 orthodontists. To assess reliability, Kappa statistics were calculated. The trials were tested statistically with t-tests. Results Comparisons within each trial showed no statistically significant differences in the mean 8-year index scores or their distributions between the common protocol and the local team protocol. The mean index scores were Trial 1: Arm A 3.03, Arm B 2.82, Trial 2: Arm A 2.78, Arm C 2.64, and Trial 3: Arm A 3.06, Arm D 3.08. Comparisons between the trials detected a significantly (P < 0.005) better mean index score Trial 2 Arm C than in Trial 3 Arm D. The intra- and inter-rater reliabilities were acceptable. Conclusion The results of these three trials do not provide evidence that one surgical protocol is better than the others. Trial registration ISRCTN29932826

BACKGROUND AND AIM: Good dentofacial development and good occlusion are main goals in the treatment of UCLP. The aim was to evaluate dental occlusion at age 5 years with the Huddart and Bodenham index after four different protocols of primary surgery for UCLP.DESIGN: Three parallel randomised controlled trials were undertaken as an international multicentre study by 10 cleft teams in five countries: Denmark, Finland, Sweden, Norway, and the UK.METHODS: Three different surgical procedures for primary palatal repair (Arms B, C, and D) were tested against a common procedure (Arm A) in the total cohort of 448 children born with non-syndromic UCLP. Dental casts of 418 patients (272 boys, 146 girls), at the mean age of 5.1 years (range =4.7-6.9) were blindly assessed by 10 orthodontists with the original Huddart and Bodenham index. The main outcome measure was dental occlusion.RESULTS: The inter- and intra-examiner reliability was good-to-excellent (0.61-0.94; 0.66-1.0, respectively). The mean total scores (+2 to -18) varied from -5.56 (Trial 2C) to -7.21 (Trial 3D). The mean anterior scores (+2 to -6) varied from -1.66 (Trial 2C) to -2.56 (Trial 3A). The mean posterior cleft-side scores (0 to -6) varied from -3.24 (Trial 3A) to -3.82 (Trial 3D) and the mean non-cleft-side scores (0 to -6) varied from -0.60 (Trial 2C) to -1.30 (Trial 3A); however, no significant differences were found within the trials.CONCLUSION: There was no statistical evidence of a difference in occlusion between the two surgical methods in each trial.TRIAL REGISTRATION: ISRCTN29932826.

Facial appearance is one of the most relevant measures of success in cleft lip and palate treatment. The aim was to assess nasolabial appearance at 5 years of age in all children in the project. In this part of the project the local protocol for lip closure continued to be used because the primary lip and nose operations were not part of the randomisation. The great majority of the surgeons used Millard's technique together with McComb's technique for the nose. One center used Tennison-Randalls technique and in one center the centers own technique as well as nose plugs were used.Three hundred and fifty-nine children participated in this part of the project. Standardised photos according to a specific protocol developed for the Scandcleft project were taken. Only the nasolabial area was shown, the surrounding facial features were masked. Three components were scored using a 5-point ordinal scale. A new developed Scandcleft Yardstick was used.The reliability of the method was tested using the weighted kappa statistics. Both the interrater and intrarater reliability scores were good to very good. There were statistically significant differences between the three trials.The Millard procedure combined with McComb technique had been used in the majority of the cases in all three trials. There were statistically significant differences between the three trials concerning upper lip, nasal form, and cleft side profile.ISRCTN29932826.

Objective This study sought to evaluate long-term dental arch relationships in adults with a unilateral complete cleft lip and palate (UCLP) treated by the Utrecht protocol and to compare results with the centers from the Eurocleft study. Materials and methods Retrospective analysis of UCLP patients age 17 or older, treated by two-stage palate closure at the Wilhelmina Children's Hospital, a tertiary center for cleft surgery in Utrecht, the Netherlands. Patients were invited to the clinic for a long-term evaluation. Casts were obtained on the day of follow-up and assessed by the modified Goslon Yardstick for permanent dentition. Dental casts were scored twice by 3 different examiners. Results Intra-rater agreement varied from 0.743 to 0.844, the inter-rater agreement from 0.552 to 0.718. The mean Goslon Yardstick score was 3.3. Thirty-three percent of the patients had a Goslon score of 1 or 2, 45% had a score of 4 or 5. Conclusions The present study found unfavourable results regarding dental arch relationships after delayed hard palate closure at 3 years old. The mean Goslon Yardstick score was 3.3 (SD 1.4) and 45% of the casts were allocated to group 4 or 5 despite extensive orthodontic treatment. We observed a high number of secondary surgical interventions but no evident benefit regarding dental occlusion following the Utrecht treatment protocol, which includes a two-stage palatoplasty. Other factors than the timing of palate closure are likely of influence.

Summary Objectives To assess differences in craniofacial growth at 8 years of age according to the different protocols for primary cleft surgery in the Scandcleft project. Design and setting Prospective, randomized, controlled clinical trial (RCT) involving 10 centres, including non-syndromic Caucasians with unilateral cleft lip and palate (UCLP). In Trial 1, a common surgical method (1a) with soft palate closure at 3–4 months of age and hard palate closure at 12 months of age was tested against similar surgery but with hard palate repair at 36 months (delayed hard palate closure) (1b). In Trial 2, the common method (2a) was tested against simultaneous closure of both hard and soft palate at 1 year (2c). In Trial 3, the common method (3a) was tested against hard palate closure together with lip closure at 3 months of age and soft palate closure at 1 year of age (3d). Participants were randomly allocated by use of a dice. Operator blinding was not possible but all raters of all outcomes were blinded. Subjects and methods The total number of participating patients at 8 years of age was 429. Lateral cephalograms (n = 408) were analysed. The cephalometric angles SNA and ANB were chosen for assessing maxillary growth for this part of the presentation. Results Within each trial (Trial 1a/1b, Trial 2a/2c, and Trial 3a/3d), there was no difference in cephalometric values between the common and the local arm. There were no statistically significant differences in the SNA and ANB angles between the common arm in Trial 1a (mean SNA 77.8, mean ANB 2.6) and Trial 2a (mean SNA 79.8, mean ANB 3.6) and no difference between Trial 1a and Trial 3a, but a statistical difference could be seen between Trial 2a and Trial 3a (mean SNA 76.9, mean ANB 1.7). However, the confidence interval was rather large. Intra- and inter-rater reliability were within acceptable range. Conclusions The timing and the surgical method is not of major importance as far as growth outcomes (SNA and ANB) in UCLP are concerned. Registration ISRCTN29932826 Protocol The protocol was not published before trial commencement.

IntroductionCleft palate is among the most common birth abnormalities. The success of primary surgery in the early months of life is crucial for successful feeding, speech, hearing, dental development and facial growth. Over recent decades, age at palatal surgery in infancy has reduced. This has led to palatal closure in one-stage procedures being carried out around the age of 12 months, but in some cases as early as 6 months. The primary objective of the Timing Of Primary Surgery for Cleft Palate (TOPS)trial is to determine whether surgery for cleft palate performed at 6 or 12 months of age is most beneficial for speech outcomes.Methods and analysisInfants with a diagnosis of non-syndromic isolated cleft palate will be randomised to receive standardised primary surgery (Sommerlad technique) for closure of the cleft at either 6 months or 12 months, corrected for gestational age. The primary outcome will be perceived insufficient velopharyngeal function at 5 years of age. Secondary outcomes measured across 12 months, 3 years and 5 years will include growth, safety of the procedure, dentofacial development, speech, hearing level and middle ear function. Video and audio recordings of speech will be collected in a standardised age-appropriate manner and analysed independently by multiple speech and language therapists. The trial aims to recruit and follow-up 300 participants per arm. Data will be analysed according to the intention-to-treat principle using a 5% significance level. All analyses will be prespecified within a full and detailed statistical analysis plan.Ethics and disseminationEthical approval has been sought in each participating country according to country-specific procedures. Trial results will be presented at conferences, published in peer-reviewed journals and disseminated through relevant patient support groups.Trial registration numberNCT00993551; Pre-results.

Background The Scandcleft international multicenter study is a prospective clinical trial of the long-term outcome after four different surgical protocols for palatal closure in patients born with unilateral cleft lip and palate (UCLP). This paper is one of a series of follow-up studies in 8-year olds. Objectives To evaluate the dental occlusion of 8-year-old patients after four different protocols of primary surgery for UCLP. Trial design Ten cleft centres in five countries tested three different surgical procedures for primary palatal repair in three parallel trials (Arms B, C, and D) against a common procedure (Arm A). Methods Initially 448 children born with non-syndromic UCLP were included in the project. At 8 years of age, 428 children remained in the study. Dental casts of 411 patients (270 boys, 141 girls), mean age 8.1 years (range 7.0-10.0) were taken. The casts were blindly assessed with the Modified Huddart and Bodenham (MHB) index by four orthodontists. The main outcome measures were anterior (+2 to -6) and posterior (0 to -8) mean scores. Comparisons were made with previous data in 5-year-olds. Results The inter- and intra-examiner reliability was good to excellent (0.75-0.90; 0.73-0.97), respectively. The mean total scores varied from -7.09 (Trial 2C) to -10.13 (Trial 3D). The mean anterior scores varied from -1.75 (Trial 2C) to -3.18 (Trial 1A). The mean posterior cleft-side scores varied from -4.32 (Trial 1B) to -5.21 (Trial 3D) and the mean non-cleft-side scores varied from -0.88 (Trial 2C) to -2.40 (Trial 3A). No significant differences were found within the trials. A significant difference was found between Trials 2 and 3 (Arm C/D) for the total score (P = 0.004). Conclusions There was no evidence of clinically significant differences in occlusion between the two surgical methods in each trial or between the trials. All mean scores showed more negative values in 8-year-olds compared with previously reported values in 5-year-olds. Trial registration ISRCTN29932826.

Objectives: 1. To evaluate the orthodontic burden of care of nasoalveolar molding (NAM) and modified McNeil for the treatment of patients with complete unilateral cleft lip and palate (CUCLP). 2. To compare the esthetic outcomes of each with those of centers not utilizing infant orthopedics (IO). Design: Retrospective cohort study. Setting: Institutional. Participants: Four cohorts with repaired CUCLP (n = 149) from 3 centers. Interventions: Two cohorts were treated in the same center and had either traditional infant orthopedics (TIO) or NAM and 2 were treated in centers not employing IO. Main Outcome Measures: Burden of care data for the IO groups were compared using t tests. Frontal and profile photographs at approximately age 5 were collected for ratings of nasolabial esthetics, using a modification of the Asher-McDade method. Intrarater and interrater reliabilities were determined using weighted κ statistics. Median ratings were compared using a Kruskal-Wallis test. Results: The burden of care of NAM was significantly greater than TIO for both the number of visits (9.9 vs 6.6, [ P < .001]); and treatment duration (127 vs 112 days, [ P < .05]). Significant differences in nasolabial esthetic ratings were noted among the 3 centers. No significant differences were observed in the nasolabial esthetic outcomes between the NAM and TIO groups. Conclusions: 1. NAM required more visits and longer overall duration compared with TIO. 2. The center employing IO showed favorable nasolabial esthetics compared to those not utilizing IO. 3. No significant differences were found in the nasolabial esthetics of patients who have received NAM compared with TIO.

Objective: To compare nasolabial appearance outcomes of patients with complete unilateral cleft lip and palate (CUCLP) in preadolescence from 4 cleft centers including a center using nasoalveolar molding (NAM) and primary nasal reconstruction. Design: Retrospective cohort study. Setting: Four cleft centers in North America. Patients: 135 subjects with repaired CUCLP. Methods: Frontal and profile facial pictures were assessed using the Asher-McDade rating scale. Intra- and interrater reliability were tested using weighted Kappa statistics. Median scores by center were compared with Kruskal-Wallis statistics. Results: Intrarater reliability scores were moderate to good. Interrater reliability scores were moderate. Significant differences ( P < .05) among centers were found. For nasal form, center G (median = 2.83) had better scores than centers C and D (C median = 3.33, D median = 3.17). For nose symmetry, center G had better scores (median = 2.33) than all other centers (B median = 2.67, C median = 2.83, D median = 2.83). For vermillion border, center G had better scores (median = 2.58) than centers B and C (B median = 3.17, C median = 3.17). For nasolabial profile, center G (median score = 2.67) had better scores than center C (median = 3.00). For total nasolabial score, center G (median = 2.67) had better scores than all other centers (B median = 2.83, C median = 3, D median = 2.83). Conclusion: The protocol followed by center G, the only center that performed NAM and primary nasal reconstruction, produced better results in all categories when compared to center C, the only center that did not perform presurgical orthopedics or lip/nose revisions. When compared to centers that performed traditional presurgical orthopedics and surgical revisions (B and D), center G was not consistently better in all categories. As with other uncontrolled, retrospective intercenter studies, it is not possible to attribute the outcomes to a specific protocol component.

The purpose of this study was to investigate ways to improve rater reliability and satisfaction in nasolabial esthetic evaluations of patients with complete unilateral cleft lip and palate (UCLP), by modifying the Asher-McDade method with use of Q-sort methodology. Blinded ratings of cropped photographs of one hundred forty-nine 5- to 7-year-old consecutively treated patients with complete UCLP from 4 different centers were used in a rating of frontal and profile nasolabial esthetic outcomes by 6 judges involved in the Americleft Project's intercenter outcome comparisons. Four judges rated in previous studies using the original Asher-McDade approach. For the Q-sort modification, rather than projection of images, each judge had cards with frontal and profile photographs of each patient and rated them on a scale of 1 to 5 for vermillion border, nasolabial frontal, and profile, using the Q-sort method with placement of cards into categories 1 to 5. Inter- and intrarater reliabilities were calculated using the Weighted Kappa (95% confidence interval). For 4 raters, the reliabilities were compared with those in previous studies. There was no significant improvement in inter-rater reliabilities using the new method. Intrarater reliability consistently improved. All raters preferred the Q-sort method with rating cards rather than a PowerPoint of photos, which improved internal consistency in rating compared to previous studies using the original Asher-McDade method. All raters preferred this method because of the ability to continuously compare photos and adjust relative ratings between patients.

Background and aims: Longstanding uncertainty surrounds the selection of surgical protocols for the closure of unilateral cleft lip and palate, and randomised trials have only rarely been performed. This paper is an introduction to three randomised trials of primary surgery for children born with complete unilateral cleft lip and palate (UCLP). It presents the protocol developed for the trials in CONSORT format, and describes the management structure that was developed to achieve the long-term engagement and commitment required to complete the project. Method: Ten established national or regional cleft centres participated. Lip and soft palate closure at 3–4 months, and hard palate closure at 12 months served as a common method in each trial. Trial 1 compared this with hard palate closure at 36 months. Trial 2 compared it with lip closure at 3–4 months and hard and soft palate closure at 12 months. Trial 3 compared it with lip and hard palate closure at 3–4 months and soft palate closure at 12 months. The primary outcomes were speech and dentofacial development, with a series of perioperative and longer-term secondary outcomes. Results: Recruitment of 448 infants took place over a 9-year period, with 99.8% subsequent retention at 5 years. Conclusion: The series of reports that follow this introductory paper include comparisons at age 5 of surgical outcomes, speech outcomes, measures of dentofacial development and appearance, and parental satisfaction. The outcomes recorded and the numbers analysed for each outcome and time point are described in the series. Trial registration: ISRCTN29932826.

BackgroundNonsyndromic cleft lip with or without cleft palate (nsCL±P) and nonsyndromic cleft palate (nsCP) are caused by a combination of genetic and environmental risk factors. We investigated gene-environment and gene-gene joint effects in a large multicenter study of case-parent triads.MethodsThe nsCL±P or nsCP triads were recruited in 11 European countries between 2001 and 2005. We collected DNA samples from infants and from their mothers and fathers, and mothers completed a questionnaire on exposures, including smoking and folic acid supplement use during pregnancy. We used log-linear regression to estimate relative risks (RRs) and 95% confidence intervals (CIs) for associations between nsCL±P or nsCP and variants in MTHFR, MTHFD1, TGFA, SATB2, and MSX1, stratifying by environmental or genetic factors.ResultsWe obtained genotype and exposure data for 728 nsCL±P triads and 292 nsCP triads. In male infants, there was no association between the mother's homozygous MSX1 p(CA)∗4/∗4 genotype and nsCL±P (RR, 0.98; 95% CI, 0.63–1.54), but this maternal genotype resulted in a doubling of risk for female infants (RR, 2.21; 95% CI, 1.13–4.34). There was evidence suggestive of gene-gene joint-effects between MTHFR-TGFA for nsCP but not for nsCL±P.ConclusionAlthough we chose the genes and their variants and putative joint effects based on associations previously reported in the literature, we replicated few associations. These results do not provide evidence supporting associations between these genes and oral clefts in European populations, although gene-environment and gene-gene interactions could play a role in oral cleft etiology.

Background and aims: Longstanding uncertainty surrounds the selection of surgical protocols for unilateral cleft lip and palate (UCLP), and randomised trials have only occasionally been performed. The Scandcleft Project consists of three trials initiated in 1997. The results at age 5 have been published in the series of reports that precede this manuscript, which aims to distill some of the issues that future trialists may need to address. Method: The shared experience of this group of trials is reviewed with reference to the current literature on trial management and, more specifically, trials of surgical technique and timing. Results: The main discussion points relate to the challenges associated with research bureaucracy, learning curve, individuality of skill, and ethics. Conclusions: Compliance with current regulatory requirements for clinical trials and recruitment rates for cleft sub-types represent substantial challenges. Mastery of new surgical techniques prior to trials raises important ethical issues, although recent reports in the wider surgical literature suggest that learning may be hastened with the assistance of anonymised peer review ratings of intraoperative performance. The three Scandcleft Trials succeeded in meeting the planned recruitment targets, and completed follow-up with remarkably high retention rates (99.3%). The design of the study required the majority of participating surgeons to master a new technique and, although overall outcomes were comparable with those in the literature, the associated learning curve increased postoperative complications in two of the trials. Trial registration: ISRCTN29932826.

Objective: To compare dental arch relationship and craniofacial morphology of patients with CUCLP in pre-adolescence from five cleft centers including a center using NAM. Design: Retrospective cohort study. Setting: Five cleft centers in North America. Patients: One hundred eighty-two subjects with repaired CUCLP from the five cleft centers participated in the craniofacial form study. One hundred forty-eight subjects from four of the five centers participated in the dental arch relationship study. Methods: Digital dental models were assessed using the GOSLON Yardstick. Eighteen cephalometric measurements were performed. Measurement means, by center, were compared. Analysis of variance and Tukey-Kramer analysis were used to compare GOSLON scores and cephalometric measurements. Results: The center that performed neither PSOT (including NAM) nor primary bone grafting exhibited the most favorable mean GOSLON score. The same center also showed the highest mean SNA, ANB, and ANS-N-Pg angles. However, the mean ANB and ANS-N-Pg angles were not significantly different from those of the center using NAM. No statistically significant differences were seen for mandibular prominence, vertical dimensions, or dental inclinations. The center with NAM also showed a significantly smaller nasoform angle than two of the four other centers. Conclusion: The centers that used NAM and other forms of PSOT did not have better dental arch relationships or craniofacial morphology compared with the centers that performed only primary lip repair. However, this study was not designed to investigate the cause-and-effect relationship between specific outcomes and particular features of those protocols.

BACKGROUND AND AIM: Good dentofacial growth is a major goal in the treatment of unilateral cleft lip and palate (UCLP). The aim was to evaluate dental arch relationships at age 5 years after four different protocols of primary surgery for UCLP.DESIGN: Three parallel randomised clinical trials were undertaken as an international multi-centre study by 10 cleft teams in five countries: Denmark, Finland, Sweden, Norway, and the UK.METHODS: Three different surgical procedures for primary palatal repair (Arms B, C, D) were tested against a common procedure (Arm A) in the total cohort of 448 children born with non-syndromic UCLP. Study models of 418 patients (273 boys) at the mean age of 5.1 years (range = 4.8-7.0) were available. Dental arch relationships were assessed using the 5-year index by a blinded panel of 16 orthodontists. Kappa statistics were calculated to assess reliability. The trials were tested statistically with t- and Chi-square tests.RESULTS: Good-to-very good levels of intra- and interrater reliability were obtained (0.71-0.94 and 0.70-0.87). Comparisons within each trial showed no statistically significant differences in the mean 5-year index scores or their distributions between the common method and the local team protocol. The mean index scores varied from 2.52 (Trial 2, Arm C) to 2.94 (Trial 3, Arm D).CONCLUSION: The results of the three trials do not provide statistical evidence that one technique is better than the others. Further analysis of the possible influence of individual surgical skill and learning curve are being pursued in this dataset.TRIAL REGISTRATION: ISRCTN29932826.

Purpose:The purpose of this study was to investigate the validity of timing gates and 10-Hz global positioning systems (GPS) units (Catapult Optimeye S5) against a criterion measure (50-Hz radar gun) for assessing maximum sprint velocity (Vmax).Methods:Nine male professional rugby union players performed 3 maximal 40-m sprints with 3 min rest between efforts with Vmax assessed simultaneously via timing gates, 10-Hz GPSOpen (Openfield software), GPSSprint (Sprint software), and radar gun. Eight players wore 3 GPS units, while 1 wore a single unit during each sprint.Results:When compared with the radar gun, mean biases for GPSOpen, GPSSprint, and timing gates were trivial, small, and small, respectively. The typical error of the estimate (TEE) was small for timing gate and GPSOpen while moderate for GPSSprint. Correlations with radar gun were nearly perfect for all measures. Mean bias, TEE, and correlations between GPS units were trivial, small, and nearly perfect, respectively, while a small TEE existed when GPSOpenfield was compared with GPSSprint.Conclusion:Based on these findings, both 10-Hz GPS and timing gates provide valid measures of 40-m Vmax assessment compared with a radar gun. However, as error did exist between measures, the same testing protocol should be used when assessing 40-m Vmax over time. Furthermore, in light of the above results, it is recommended that when assessing changes in GPS-derived Vmax over time, practitioners should use the same unit for each player and perform the analysis with the same software, preferably Catapult Openfield.

Item does not contain fulltext Yardsticks have been developed to measure dental arch relations in cleft lip and palate (CLP) patients as diagnostic proxies for the underlying skeletal relationship. Travelling with plaster casts to compare results between CLP centres is inefficient so the aim of this study was to investigate the reliability of using digital models or photographs of dental casts instead of plaster casts for rating dental arch relationships in children with complete bilateral cleft lip and palate (CBCLP). Dental casts of children with CBCLP (n=20) were included. Plaster casts, digital models and photographs of the plaster casts were available for all the children at 6, 9, and 12 years of age. All three record formats were scored using the bilateral cleft lip and palate (BCLP) yardstick by four observers in random order. No significant differences were found for the BCLP yardstick scores among the three formats. The interobserver weighted kappa scores were between 0.672 and 0.934. Comparison between the formats per observer resulted in weighted kappa scores between 0.692 and 0.885. It is concluded that digital models and photographs of dental casts can be used for rating dental arch relationships in patients with CBCLP. These formats are a reliable alternative for BCLP yardstick assessments on conventional plaster casts. 01 februari 2012

Background Powered brushes were first introduced commercially in the 1960s. A recent systematic review suggested the superiority of certain modes of powered over manual toothbrushing for plaque and gingivitis reduction. That review did not allow for direct comparison between different modes of powered toothbrush. Objectives To compare different modes of powered toothbrushing against each other for plaque reduction and the health of the gingivae. Other factors to be assessed were calculus and stain removal, cost, dependability and adverse effects. Search strategy The following databases were searched: Cochrane Oral Health Group's Trials Register (to 26 July 2010); Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 3); MEDLINE via OVID (1950 to 26 July 2010); EMBASE via OVID (1980 to 26 July 2010); CINAHL via EBSCO (1982 to 26 July 2010). There were no language restrictions. Selection criteria Trials were considered for inclusion with the following criteria: random allocation of participants; no compromised manual dexterity; unsupervised powered toothbrushing for at least 4 weeks. The primary outcomes were the plaque and gingivitis scores after powered toothbrush use during trial period. Data collection and analysis Data extraction was performed independently and in duplicate. The authors of trials were contacted to provide missing data where possible. The effect measure for each meta-analysis was the standardised mean difference (SMD) with 95% confidence intervals (CI) using the random-effects model. Potential sources of heterogeneity were assessed. Main results The review included data from 17 trials with 1369 participants. There is evidence from seven trials of up to three months and at unclear/high risk of bias that rotation oscillation brushes reduce plaque (SMD 0.24; 95% CI 95% 0.02, 0.46) and gingivitis (SMD 0.35; 95% CI -0.04, 0.74) more than side to side brushes. Due to the dearth of trials, no other definitive conclusions can be stated regarding the superiority of one mode of powered toothbrush over any other. Only minor and transient side effects were reported. Cost, dependability were not reported. Authors' conclusions There is some evidence that rotation oscillation brushes reduce plaque and gingivitis more than side to side brushes in the short term. This difference is small and it's clinical importance is unclear. Further trials of good quality are required to assess the superiority of other modes of action for powered toothbrushes. Plain Language Summary Different types of powered toothbrushes for plaque control and healthy gums Powered brushes were first introduced commercially in the 1960s. A previously published Cochrane systematic review suggested one type of powered brush was superior to manual toothbrushing for the removal of plaque and reduction of gum inflammation.That review did not allow direct comparison between the different types of powered toothbrushes. This review included data from 17 trials with 1369 participants. Brushes with a rotation oscillation action reduced plaque and gingivitis more than those with a side to side action in the short term. However, the difference was small and it's clinical importance unclear. Due to the low numbers of trials using other types of powered brushes, no other definitive conclusions can be drawn regarding the superiority of one type of powered toothbrush over another. Only minor and transient side effects were reported. Cost and reliability of the brushes were not reported in the trials. Further trials of good quality are required to establish if other types of powered brush are better at reducing plaque and gingivitis.

Objective To compare the nasolabial aesthetics for individuals with nonsyndromic complete unilateral cleft lip and palate between the ages of 5 and 12 years. Design Retrospective cross-sectional study. Setting Four cleft centers in North America. Subjects A total of 124 subjects with repaired complete unilateral cleft lip and palate who were treated at the four centers. Methods After ethics approval was obtained, 124 preorthodontic frontal and profile patient images were scanned, cropped to show the nose and upper lip, and coded. Using the coded images, four nasolabial features that reflect aesthetics (i.e., nasal symmetry, nasal form, vermilion border, and nasolabial profile) were rated by five examiners using the rating system reported by Asher-McDade et al. (1991) . Intrarater and interrater reliabilities were determined using weighted kappa statistics. Mean ratings, by center, were compared using analysis of variance. Results Intrarater reliability scores were good to very good and interrater reliability scores were moderate to good. Total nasolabial scores were Center B = 2.98, Center C = 3.02, Center D = 2.80, and Center E = 2.87. No statistically significant differences among centers were detected for both total aesthetic scores and for any of the individual aesthetic components. Conclusion There were no significant differences in nasolabial aesthetics among the centers evaluated. Overall good to fair nasolabial aesthetic results were achieved using the different treatment protocols in the four North American centers.

Objective To compare craniofacial morphology for individuals with nonsyndromic complete unilateral cleft lip and palate between the ages of 6 and 12 years. Design Retrospective cohort study. Setting Four North American cleft palate centers. Subjects A total of 148 subjects with repaired complete unilateral cleft lip and palate who were consecutively treated at the four centers. Methods The 148 preorthodontic lateral cephalometric radiographs were scanned, scaled, digitized, and coded to blind the examiners to radiograph origin. On each radiograph, 18 (angular and ratio) cephalometric measurements were performed. Measurement means, by center, were compared using analysis of variance and Tukey-Kramer analysis. Results Significant differences were found for sagittal maxillary prominence among the four centers. The most significant difference was seen between Center B (lowest SNA) and Center C (highest SNA). Similar differences were seen at the soft tissue level, with Center C showing a significantly larger ANB angle compared with Centers B and D. Center C was also shown to have statistically greater mean soft tissue convexity than Centers B, D, and E. The mean nasolabial angle in Center B was significantly more acute than in Centers C, D, and E. No statistically significant differences were seen for mandibular prominence, vertical dimensions, or dental inclinations. Conclusion Significant differences were seen among the centers for hard and soft tissue maxillary prominence, but not for mandibular prominence, vertical dimensions, or dental inclinations. A modest but statistically significant ( p < .001) negative correlation was found between Goslon scores and ANB angle ( r = –.607).

Objective To compare maxillomandibular relationships for individuals with nonsyndromic complete unilateral cleft lip and palate using the Goslon Yardstick for dental models. Design Retrospective cohort study. Setting Five cleft palate centers in North America. Subjects A total of 169 subjects with repaired complete unilateral cleft lip and palate who were consecutively treated at the five centers. Methods Ethics approval was obtained. A total of 169 dental models of patients between 6 and 12 years old with complete unilateral cleft lip and palate were assessed using the Goslon Yardstick. Weighted kappa statistics were used to assess intrarater and interrater reliabilities; whereas, analysis of variance and Tukey-Kramer analysis was used to compare the Goslon scores. Significance levels were set at p < .05. Results Intrarater and interrater reliabilities were very good for model ratings. One center that incorporated primary alveolar bone grafting showed especially poor Goslon scores that were significantly poorer than the remaining centers. The surgery protocols used by the other four centers did not include primary alveolar bone grafting but involved a number of different lip and palate closure techniques. Using the Goslon Yardstick assumptions, the center with the best scores would be expected to require end-stage maxillary advancement orthognathic surgery in 20% of its patients; whereas, the center with the worst scores would be likely to require this surgery in 66% of its patients. Conclusions The Goslon Yardstick proved capable of discriminating among the centers’ dental arch relationships. Possible explanations for the differences are discussed.

The birth prevalence of orofacial clefts, one of the most common congenital anomalies, is approximately one in 700 live births, but varies with geography, ethnicity, and socio-economic status. There is a variation in infant mortality and access to care both between and within countries, so some clefts remain unrepaired into adulthood. Quality of care also varies, and even among repaired clefts there is residual deformity and morbidity that significantly affects some children. The two major issues in attempts to address these inequalities are (a) etiology/possibilities for prevention and (b) management and quality of care. For prevention, collaborative research efforts are required in developing countries, in line with the WHO approach to implement the recommendations of the 2008 Millennium Development Goals ( www.un.org/millenniumgoals ). This includes the “common risk factor” approach, which analyzes biological and social determinants of health alongside other chronic health problems such as diabetes and obesity, as outlined in the Marmot Health inequalities review (2008) ( www.ucl.ac.uk/gheg/marmotreview ). Simultaneously, orofacial cleft research should involve clinical researchers to identify inequalities in access to treatment and identify the best interventions for minimizing mortality and residual deformity. The future research agenda also requires engagement with implementation science to get research findings into practice.

ObjectiveTo compare and evaluate longitudinally the dental arch relationships from 4.5 to 13.5 years of age with the Bauru-BCLP Yardstick in a large sample of patients with bilateral cleft lip and palate (BCLP).DesignRetrospective longitudinal intercenter outcome study.PatientsDental casts of 204 consecutive patients with complete BCLP were evaluated at 6,9, and 12 years of age. All models were identified only by random identification numbers.SettingThree cleft palate centers with different treatment protocols.Main Outcome MeasuresDental arch relationships were categorized with the Bauru-BCLP yardstick. Increments for each interval (from 6 to 9 years, 6 to 12 years, and 9 to 12 years) were analyzed by logistic and linear regression models.ResultsThere were no significant differences in outcome measures between the centers at age 12 or at age 9. At age 6, center B showed significantly better results ( p = .027), but this difference diminished as the yardstick score for this group increased over time (linear regression analysis), the difference with the reference category (center C, boys) for the intervals 6 to 12 and 9 to 12 years being 10.4% ( p = .041) and 12.9% ( p = .009), respectively.ConclusionsDespite different treatment protocols, dental arch relationships in the three centers were comparable in final scores at age 9 and 12 years. Delaying hard palate closure and employing infant orthopedics did not appear to be advantageous in the long run. Premaxillary osteotomy employed in center B appeared to be associated with less favorable development of the dental arch relationship between 9 and 12 years.

Clefts of the lip and palate are generally divided into two groups, isolated cleft palate and cleft lip with or without cleft palate, representing a heterogeneous group of disorders affecting the lips and oral cavity. These defects arise in about 1.7 per 1000 liveborn babies, with ethnic and geographic variation. Effects on speech, hearing, appearance, and psychology can lead to longlasting adverse outcomes for health and social integration. Typically, children with these disorders need multidisciplinary care from birth to adulthood and have higher morbidity and mortality throughout life than do unaffected individuals. This Seminar describes embryological developmental processes, epidemiology, known environmental and genetic risk factors, and their interaction. Although access to care has increased in recent years, especially in developing countries, quality of care still varies substantially. Prevention is the ultimate objective for clefts of the lip and palate, and a prerequisite of this aim is to elucidate causes of the disorders. Technological advances and international collaborations have yielded some successes.

Objectives: The aim of the study was to investigate the prevalence of orofacial pain (OFP) among young adults (30-31 years old) and to determine the effect of childhood and adulthood risk factors on the occurrence of OFP. Methods: Prospective cohort study to investigate dental and social effects of malocclusion and effectiveness of orthodontic treatment was conducted in Wales, United Kingdom. At 20-year follow-up 337 subjects aged 30-31 participated (74% from previous follow-up aged 19-20 and 33% from the baseline) and were asked about OFP. Results: The prevalence of OFP was 23% (95% CI: 19%, 28%). Childhood factors, socio-demographic, lifestyle, health behavior factors, history of orthodontic treatment and tooth wear were not associated with OFP. Participants with OFP were more likely to report that their teeth did not fit together properly [odds ratio (OR) = 12.4, 95% CI: 2.7-56.5) and reported previous trauma to the jaws (2.3; 1.3-4.2). Both diurnal and nocturnal teeth clenching and grinding were significantly associated with OFP (3.1; 1.4-7.1). Participants with frequent headaches had increased risk of having OFP (3.7; 1.6-8.4) while having reported 4-10 types of pain in other parts of the body other than the head, was associated with OR = 9.2 (3.7-23.0). An increased tendency to have OFP was seen in those individuals with higher levels of psychological distress (2.3; 1.4-3.9), high score on Life Event Inventory (2.6; 1.3-5.3), depressive symptoms (2.2; 1.2-4.0) and stress (2.2; 1.2-4.0). High self-esteem associated with lower risk of OFP (0.5; 0.3-0.9). Conclusions: This study shows that OFP is frequently reported by young adults aged 30-31 and supports a multifactorial etiology with factors from many domains, including local mechanical factors, psychological and co-morbidities. However, none of the childhood factors considered in this study were associated with OFP in adulthood.

Introduction: Despite the widespread expectation that orthodontic treatment improves psychological well-being and self-esteem, there is little objective evidence to support this. The aim of this study was to compare the dental and psychosocial status of people who received, or did not receive, orthodontic treatment as teenagers. Methods: A prospective longitudinal cohort design was adopted. A multidisciplinary research team evaluated 1018 participants, aged 11 to 12 years, in 1981. Extensive assessments of dental health and psychosocial well-being were conducted; facial and dental photographs and plaster casts of dentition were obtained and rated for attractiveness and pretreatment need. No recommendations about orthodontic treatment were made, and an observational approach was adopted. At the third follow-up, 337 subjects (30-31 years old) were reexamined in 2001. One-way ANOVA was used to explore differences between the 4 groups (need/no need; treatment/no treatment). Results: The percentage changes in index of complexity, outcome and need scores for the 4 groups were need/no treatment (12.7%), no need/no treatment (−17.1%), need/treatment (31%), and no need/treatment (−11.4%). Participants with a prior need for orthodontic treatment as children who obtained treatment had better tooth alignment and satisfaction. However, when self-esteem at baseline was controlled for, orthodontic treatment had little positive impact on psychological health and quality of life in adulthood. Conclusions: Lack of orthodontic treatment when there was need did not lead to psychological difficulties in later life.

Outcomes of cleft lip and palate care can be divided into clinical, psychosocial, and systems of care.1 Systems of care include the burden of care experienced by patients and the costs of delivering care. Unlike cost of care, which has been extensively studied in children with clefts,2–5 less is known about the patients’ burden of care. Burden of secondary surgery is an important measure for patients, families, and health-care payers. Secondary surgery causes substantial pain and fear for children and time off work for families. Secondary surgery also leads to direct costs of $6000–$12,000 per surgery.2,4,5 For these reasons, information on the use of secondary surgery is highly relevant. Primary cleft surgery and secondary cleft surgery are distinct categories of surgical interventions.6,7 Primary surgery includes the initial lip repair, with or without rhinoplasty, and the initial palate repair. Secondary surgery includes lip revision to improve a child’s appearance; fistula closure, palate re-repair, or pharyngeal surgery to improve speech; and rhinoplasty performed after the initial lip repair to improve breathing or appearance. When it is possible to achieve the same or better outcomes through primary surgery alone, secondary surgery can be seen as an avoidable burden on patients and their families. The objective of this study is to describe the burden of secondary surgery among children with cleft lip and palate who participated in the Americleft Intercenter Outcome Study.8 This group of children was chosen for the following reasons: all participating children had nonsyndromic complete unilateral cleft lip and palate, thus minimizing variation because of differences in the initial cleft deformity; within each center, children were treated according to consistent protocols, minimizing variation because of changes in treatment protocol; lastly, dental, aesthetic, and facial growth outcomes of these patients have been previously described using objective measures.8–12 The central hypothesis of this study was that the cleft center where a child was initially treated predicts whether or not that child subsequently had secondary surgery.

Objective To assess secondary alveolar bone graft (ABG) outcomes using the standardized way to assess grafts, or SWAG scale, for patients with cleft lip and palate (CLP). Design Retrospective cohort study. Setting Four cleft centers with different protocols. Methods One hundred sixty maxillary occlusal radiographs taken 3 to 18 months after secondary ABG for sequentially treated patients with CLP were assessed using the SWAG scale. Radiographs were scanned, standardized, blinded, and rated by six orthodontists using the SWAG scale. Randomized radiographs were rated twice, 24 hours apart, by the same raters. Main Outcomes Intrarater and interrater reliabilities were assessed. Means and SDs were calculated for ABG ratings using analysis of variance and Tukey tests (P < .05). Result The mean ABG age was 9.1 years (range = 7 to 10.1 years) and the mean follow-up age was 12.4 years (range = 8.2 to 20.4 years). Intrarater and interrater reliabilities were good (intrarater = 0.788, interrater = 0.705), and higher than published methods. Mean ABG ratings for the cleft centers were 4.53, 2.9, 3.63, and 5.0 and differed significantly. The two centers with the highest ABG ratings showed higher ratings for all thirds decreasing from apical to coronal. The two centers with lower ABG ratings showed poorer ABG ratings for all thirds, and the middle third received the highest ratings. Conclusions The SWAG scale overcomes the challenges of age and bone location. The SWAG method was validated for showing intercenter differences for overall bone fill as well as in vertical thirds. Surgical technique, timing, and expertise/volume were identified as possible factors related to outcome.

Objective Evaluation of the dental arch relationships of Japanese patients with unilateral cleft lip and palate (UCLP) from the orthodontic clinic of the University of Tokyo Hospital (UTH) compared with patients treated by the Oslo Cleft Team, Norway. Design Retrospective study and comparison with previous reports. Materials Dental models of 24 patients with UCLP in UTH taken before orthodontic treatment and before alveolar bone grafting were included. Surgeons in many hospitals performed primary surgeries. These models were matched for age and gender with 24 models from a consecutive series of patients treated by the Oslo Cleft Team as part of the Eurocran Good Practice Archive. A total of 48 models were evaluated. Main Outcome Measure Dental arch relationship was rated with the Goslon Yardstick. The strength of agreement of rating was assessed with weighted kappa statistics. Results Intra- and interexaminer agreements evaluated by weighted kappa statistics were high, indicating good reproducibility. Almost 60% of the patients in UTH were classified into poor or very poor categories, and the mean Goslon score was 3.50. These results show a contrast to those in Oslo and were the poorest in comparison with previous reports. Conclusion Dental arch relationships in patients with UCLP in UTH were poor. This seemed to be attributable to surgical procedures, but a factor of racial difference in the craniofacial morphology was also considered. Further intercenter research is required to clarify this point.

Objective The aim of this trial was to compare the relative effectiveness (efficacy and morbidity) of two surgical procedures for correcting velopharyngeal insufficiency (VPI). Design This was an international multicenter randomized trial to study the outcome of two surgical procedures (flap and sphincter pharyngoplasty) for speech, incidence of sleep apnea, and surgical complications. Method Ninety-seven patients 3 to 25 years old with repaired cleft palate and previously identified VPI were enrolled from five centers in the United States, Norway, and the U.K. Data were collected at presurgery, 3 months postsurgery, and 12 months postsurgery for subsequent analysis blind to the procedure. Main outcome measures included perceptual speech parameters, sleep apnea, nasalance measures, endoscopic features, and surgical complications. Results Groups for both surgical procedures achieved a high level of clinical improvement. At 3 months postsurgery, elimination of hypernasal resonance was achieved in twice as many patients after the flap procedure. This reached significance. However, at 12 months postsurgery, no statistically significant difference in outcomes remained between the two procedures for resonance, nasalance, endoscopic outcomes, or surgical complications. Flap and sphincter pharyngoplasty rarely resulted in clinically significant sleep apnea, and no difference was detected between the two procedures in the long-term incidence of sleep apnea. Conclusions Despite strongly held views in the literature concerning the relative effectiveness and safety of flap and sphincter pharyngoplasty, no significant differences were detected 1 year postoperatively.

Objective To calculate the amount of treatment and associated travel experienced by five groups of patients treated at different centers. (This data is related to outcomes and patient/parent satisfaction in subsequent papers in this series). Design A longitudinal cohort study where results were previously reported at 9 years and follow-up measurements were obtained for 12 and 17 years. Setting Multidisciplinary cleft services in Northern Europe. Subjects 127 consecutively treated individuals with repaired unilateral complete cleft lip and palate. Main Outcome Measures Numbers of surgeries and outpatient visits, number of visits, and treatment duration for early orthopedics and orthodontic treatment, associated travel time and difficulties. Results The mean number of operations per center ranged from 3.5 to 6; length of orthodontic treatment from 3.3 to 8.5 years, and attendance from 49 to 94 visits; and for early orthopedics, 0 to 15 months of treatment, 0 to 17 visits, and 0 to 146 days in hospital. Conclusion Protocols for the management of complete unilateral cleft lip and palate can vary dramatically in the burden of treatment imposed.

Objective To compare craniofacial morphology and nasolabial appearance up to age 17 in individuals with repaired complete unilateral cleft lip and palate (UCLP) treated at five European centers. Design Longitudinal cohort study. Setting Multidisciplinary cleft services in Northern Europe. Subjects 127 consecutively treated individuals with repaired complete UCLP. Main outcome measures Cephalometric variables, 14 angular and 2 ratio variables, and panel ratings of nasolabial appearance, 4 variables. Results The results revealed that at ages 12 and 17, two centers had a flatter profile (gs-sn-pgs) and retrognathic maxilla (sss-ns-sms). Additionally, one of the two centers had increased lower face height. Ratings of nasolabial appearance showed more similarity between the centers. Conclusion The results confirm that systematic differences in craniofacial morphology and nasolabial appearance may occur between different cleft centers, but do not allow specific caused factors to be identified.

Objective To compare dental arch relationships up to age 17 in individuals with complete unilateral cleft lip and palate (UCLP) treated at five European centers. Design Longitudinal cohort study, where results were previously reported at 9 years and follow-up measurements were obtained for 12 and 17 years. Setting Multidisciplinary cleft services in Northern Europe. Subjects 127 consecutively treated individuals with repaired UCLP. Main outcome measure Panel rating of dental arch relationship. Results The results revealed that at 17 years of age three of the centers had better ratings in dental arch relationship (means scores: 1.7, 1.9, and 2.2, respectively) than the other two centers (3.3, 3.4) at statistically significant levels (p < .01 to p < .001). Conclusion The results confirm that systematic differences in dental arch relationships may occur between different cleft centers, but do not allow specific causal factors to be identified.

Objective To evaluate dental arch relationships of patients with unilateral cleft lip and palate (UCLP) treated with a two-stage palatal closure and to compare them with the six centers from the Eurocleft study that used various treatment protocols. Design Repeated-measures study. Setting Cleft Palate Craniofacial Unit of Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands. Patients Records of 9-year-old children with complete unilateral cleft lip and palate (n = 43) were included. Interventions The dental arch relationships of these patients were assessed by applying the Goslon Yardstick and subsequently compared with the Goslon outcome of the six-center Eurocleft study. Mean Outcome Measures Statistics of intra- and interexaminer agreement. Results For the Nijmegen UCLP group, 9% of dental arch relationships had a Goslon score of 1, 52% had a score of 2, 30% has a score of 3, 9% had a score of 4, and none had a score of 5. The mean Nijmegen Goslon score showed no significant differences with Eurocleft centers A, B, and E, which achieved the best treatment results, but did significantly differ from Goslon outcomes of Eurocleft centers D (p < .001), C, and F (p < .01), which had relatively poor treatment outcome. Conclusions Treatment outcome of the patients in the Nijmegen UCLP group treated with two-stage palatal closure was comparable with the results of the Eurocleft centers with the best outcome. Treatment protocol could not explain differences in the quality of treatment results.

Objective To describe the soft tissue profile of children with unilateral cleft lip and palate from profile photographs and assess the reliability of this method. Design Retrospective analysis of prospectively collected data. Setting A national study in the United Kingdom. Subjects Caucasian children born in the United Kingdom between April 1, 1982, and March 31, 1984, and aged between 12 and 14 years at data collection. A cleft side and noncleft side profile photograph was available for each of 175 children. Method Seven angular measurements were made using Dentofacial Planner Plus software, and the profile appearance was rated by an expert panel. Results Reliability for repeated measurement of the same photograph was acceptable for all but li-sms-pgs (labiomental fold). Similar levels of reliability were found when comparing measurements from the cleft side and non-cleft side photograph. Logistic regression showed that the variables nst-sn-ls (nasolabial angle), sss-ns-pgs (maxillary prominence), and gs-prn-pgs (facial convexity) were associated with the profile score. Conclusions Soft tissue profile analysis from photographs is reliable and robust under a range of conditions. Soft tissue profile measurements are associated with panel ratings of profile.

Objective To propose a prospective registry for distraction osteogenesis research. Results The search strategy identified 82 reports, of which 11 were review articles, 17 were animal studies, 5 were theoretical models, and 49 were case reports/series. Conclusions So far, the literature concerning distraction osteogenesis does not allow reliable choices to be made on the most appropriate form of distraction osteogenesis in different clinical decisions or whether it is superior to osteotomy or nontreatment. A prospective registry is proposed to hasten critical appraisal of distraction osteogenesis.

Soft tissue profile analysis from cephalometric radiographs is recognized as an important part of the assessment of treatment outcome in cleft lip and palate (CLP), and has previously been found to discriminate between groups better than conventional hard tissue cephalometric analysis. Cephalometric radiographs of 182 12-14-year-old children from the UK with complete unilateral cleft lip and palate (UCLP) were available for this investigation, which aimed to describe the cephalometric soft tissue findings for this group of UK children. Seven soft tissue profile angular variables were measured using Dentofacial Planner Plus (DFP). Thirty films were re-measured two weeks later to assess the reliability of the method, which was acceptable for most of the variables, although use of landmarks related to the lips increased error. Mean nasolabial angle (97.44 degrees), facial convexity (138.02 degrees), and soft tissue ANB (2.99 degrees) compared unfavourably with previously reported data. These findings support the data given in the Clinical Standards Advisory Group study. Soft tissue profile assessment from cephalometric radiographs has acceptable reliability. The results of treatment show poor outcome in the UK compared with published data.

Objective: To determine whether palate height and maxillary arch depth are systematically related to the surgical center at which primary repair in unilateral cleft lip and palate (UCLP) was carried out. Design: A retrospective comparison based on study casts of consecutive cases of UCLP obtained at age 9 years from six different centers. The observer who conducted measurements was blinded to the source of individual records. Setting: The patients whose records were analyzed received all their surgical care in a national health service setting in six different northern European centers and regions. Patients: Patients were consecutively treated Caucasian children with non-syndromic complete UCLP born in the period 1976 to 1979. Main Outcome Measures: The main outcome measures for the original study were craniofacial form, dental arch relationships, nasolabial appearance, and speech. This report focuses on measurements of anterior maxillary arch depth and palate height. Results: Anterior arch depth and anterior palate height showed some variation among the centers. There was a tendency for anterior arch depth and palate height to also be reduced at centers at which patients showed unfavorable dental arch relationships. Conclusions: Anterior arch depth and palate height might be considered in future studies of surgical outcome and in their possible relationship to problems of articulation.

Background: Powered brushes were first introduced commercially in the 1960s. A recent systematic review suggested the superiority of certain modes of powered over manual toothbrushing for plaque and gingivitis reduction. That review did not allow for direct comparison between different modes of powered toothbrush. Objectives: To compare different modes of powered toothbrushing against each other for plaque reduction and the health of the gingivae. Other factors to be assessed were calculus and stain removal, cost, dependability and adverse effects. Search strategy: The following databases were searched: Cochrane Oral Health Group’s Trials Register (to 26 July 2010); Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 3); MEDLINE via OVID (1950 to 26 July 2010); EMBASE via OVID (1980 to 26 July 2010); CINAHL via EBSCO (1982 to 26 July 2010). There were no language restrictions. Selection criteria: Trials were considered for inclusion with the following criteria: random allocation of participants; no compromised manual dexterity; unsupervised powered toothbrushing for at least four weeks. The primary outcomes were the plaque and gingivitis scores after powered toothbrush use during trial period. Data collection and analysis: Data extraction was performed independently and in duplicate. The authors of trials were contacted to provide missing data where possible. The effect measure for each meta-analysis was the standardized mean difference (SMD) with 95% confidence intervals (CI) using the random-effects model. Potential sources of heterogeneity were assessed. Main results: The review included data from 15 trials with 1015 participants. Due to the dearth of trials assessing the same mode of action, no definitive conclusions can be stated regarding the superiority of one mode of powered toothbrush over any other. Only minor and transient side effects were reported. Cost, dependability were not reported. Authors’ conclusions: Further trials of good quality are required to establish if any mode of action has superiority over the other modes of action for powered toothbrushes. PLAIN LANGUAGE SUMMARY Different types of powered toothbrushes for plaque control and healthy gums Powered brushes were first introduced commercially in the 1960s. A previously published Cochrane systematic review suggested one type of powered brush was superior to manual toothbrushing for the removal of plaque and reduction of gum inflammation. That review did not allow direct comparison between the different types of powered toothbrushes. This review included data from 15 trials with 1015 participants. Due to the low numbers of trials using different types of powered brushes, no definitive conclusions can be drawn regarding the superiority of any one type of powered toothbrush over another. Only minor and transient side effects were reported. Cost and reliability of the brushes were not reported in the trials. Further trials of good quality are required to establish if any type of powered brush has superiority over the other types of action for powered toothbrushes.

Objective To review the history of cleft care in the United Kingdom and the rationale and methodology of a national study. Design Descriptive overview to introduce this series of papers. Setting Fifty National Health Service cleft teams. Patients/Participants Two age cohorts, 5-year-olds and 12-year-olds, with nonsyndromic complete unilateral cleft lip and palate and their parents. Main Outcome Measures Facial development and appearance, quality of bone grafts, speech, oral health and patient/parent satisfaction. Conclusions The case for a national assessment of cleft care is made. The methodology of the cross-sectional outcome study is described, together with a survey of training for recently appointed clinicians.