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Background: The presence of dental caries impacts on children's daily lives, particularly among those living in deprived areas. There are successful interventions across the United Kingdom for young children based on toothbrushing with fluoride toothpaste. However, evidence is lacking for oral health improvement programmes in secondary-school pupils to reduce dental caries and its sequelae., Objectives: To determine the clinical and cost effectiveness of a behaviour change intervention promoting toothbrushing for preventing dental caries in secondary-school pupils., Design: A multicentre, school-based, assessor-blinded, two-arm cluster randomised controlled trial with an internal pilot and embedded health economic and process evaluations., Setting: Secondary schools in Scotland, England and Wales with above-average proportion of pupils eligible for free school meals. Randomisation occurred within schools (year-group level), using block randomisation stratified by school., Participants: Pupils aged 11-13 years at recruitment, who have their own mobile telephone., Interventions: Two-component intervention based on behaviour change theory: (1) 50-minute lesson delivered by teachers, and (2) twice-daily text messages to pupils' mobile phones about toothbrushing, compared with routine education., Main Outcome Measures: Primary outcome: presence of at least one treated or untreated carious lesion using D ICDAS4-6 MFT (Decayed, Missing and Filled Teeth) in any permanent tooth, measured at pupil level at 2.5 years. Secondary outcomes included: number of D ICDAS4-6 MFT; presence and number of D ICDAS1-6 MFT; plaque; bleeding; twice-daily toothbrushing; health-related quality of life (Child Health Utility 9D); and oral health-related quality of life (Caries Impacts and Experiences Questionnaire for Children)., Results: Four thousand six hundred and eighty pupils (intervention, n  = 2262; control, n  = 2418) from 42 schools were randomised. The primary analysis on 2383 pupils (50.9%; intervention 1153, 51.0%; control 1230, 50.9%) with valid data at baseline and 2.5 years found 44.6% in the intervention group and 43.0% in control had obvious decay experience in at least one permanent tooth. There was no evidence of a difference (odds ratio 1.04, 95% confidence interval 0.85 to 1.26, p  = 0.72) and no statistically significant differences in secondary outcomes except for twice-daily toothbrushing at 6 months (odds ratio 1.30, 95% confidence interval 1.03 to 1.63, p  = 0.03) and gingival bleeding score (borderline) at 2.5 years (geometric mean difference 0.92, 95% confidence interval 0.85 to 1.00, p  = 0.05). The intervention had higher incremental mean costs (£1.02, 95% confidence interval -1.29 to 3.23) and lower incremental mean quality-adjusted life-years (-0.003, 95% confidence interval -0.009 to 0.002). The probability of the intervention being cost-effective was 7% at 2.5 years. However, in two subgroups, pilot trial schools and schools with higher proportions of pupils eligible for free school meals, there was an 84% and 60% chance of cost effectiveness, respectively, although their incremental costs and quality-adjusted life-years remained small and not statistically significant. The process evaluation revealed that the intervention was generally acceptable, although the implementation of text messages proved challenging. The COVID-19 pandemic hampered data collection. High rates of missing economic data mean findings should be interpreted with caution., Conclusions: Engagement with the intervention and evidence of 6-month change in toothbrushing behaviour was positive but did not translate into a reduction of caries. Future work should include work with secondary-school pupils to develop an understanding of the determinants of oral health behaviours, including toothbrushing and sugar consumption, particularly according to free school meal eligibility., Trial Registration: This trial is registered as ISRCTN12139369., Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 15/166/08) and is published in full in Health Technology Assessment ; Vol. 28, No. 52. See the NIHR Funding and Awards website for further award information.

Objectives: This multicentre, assessor-blinded, two-arm cluster randomized trial evaluated the clinical and cost-effectiveness of a behaviour change intervention promoting toothbrushing for preventing dental caries in UK secondary schools., Methods: Pupils aged 11-13 years with their own mobile telephone attending secondary schools with above average free school meals eligibility were randomized (at year-group level) to receive a lesson and twice-daily text messages or to usual care. Year-groups (n = 84) from 42 schools including 4680 pupils (intervention, n = 2262; control, n = 2418) were randomized., Results: In 2383 participants with valid data at baseline and 2.5 years, the primary outcome of presence of at least one treated or untreated carious lesion (D 4-6 MFT [Decayed, Missing and Filled Teeth] in permanent teeth using International Caries Detection and Assessment System) was 44.6% in the intervention group and 43.0% in control (odds ratio [OR] 1.04, 95% CI 0.85-1.26, p = .72). There were no statistically significant differences in secondary outcomes of presence of at least one treated or untreated carious lesion (D 1-6 MFT), number of D 4-6 MFT and D 1-6 MFT, plaque and bleeding scores or health-related- (Child Health Utility 9D) or oral health-related- quality of life (CARIES-QC). However, twice-daily toothbrushing, reported by 77.6% of pupils at baseline, increased at 6 months (intervention, 86.9%; control, 83.0%; OR 1.30, 95% CI 1.03-1.63, p = .03), but returned to no difference at 2.5 years (intervention, 81.0%; control, 79.9%; OR 1.05, 95% CI 0.84-1.30, p = .69). Estimated incremental costs and quality-adjusted life-years (QALYs) of the intervention, relative to control, were £1.02 (95% CI -1.29 to 3.23) and -0.003 (95% CI -0.009 to 0.002), respectively, with a 7% chance of being cost-effective (£20 000/QALY gained threshold)., Conclusion: There was no evidence of statistically significant difference for caries prevalence at 2.5-years. The intervention's positive 6-month toothbrushing behaviour change did not translate into caries reduction. (ISRCTN 12139369). COVID-19 pandemic adversly affected follow-up., (© 2024 The Authors. Community Dentistry and Oral Epidemiology published by John Wiley & Sons Ltd.)

Objective: To examine the impact of clinical, individual, and environmental factors on children's oral health-related quality of life (OHRQoL) and overall health-related quality of life (HRQoL) following dental caries management under general anaesthetic (GA)., Methods: Participants comprised 5- to 16-year-old children who were referred to a British Dental Hospital, for the management of their dental caries under GA. The Caries Impacts and Experiences Questionnaire for Children (CARIES-QC) and the Child Health Utility 9D (CHU9D) were used to assess child-reported OHRQoL and HRQoL, respectively, at baseline and 3-months follow up. A theoretical conceptual model, based on the Wilson and Cleary model of HRQOL, was evaluated using path analysis to explore indirect and direct relationships of the clinical, individual, and environmental variables on the quality of life outcomes following treatment., Results: 85 children completed the study. Path analyses revealed that 47% of the variance in OHRQoL scores was accounted for by the variables in the model. There were significant relationships between change in OHRQoL score and treatment type [extraction only vs. combination care (β = 1.41, p = 0.07)] and number of extractions (β = 0.46, p < 0.001). A higher number of tooth extractions was associated with poorer OHRQoL and HRQoL following treatment., Conclusions: Treatment type, via number of extractions, may significantly impact on child OHRQoL and HRQoL following treatment under GA. However, to identify any other factors, that might affect these key outcomes, further enquiry is warranted with a bigger sample., (© 2022. The Author(s).)

Background: Almost one-half of 12-15 year olds living in deprived areas of the UK have dental caries (tooth decay) with few oral health promotion programmes aimed at children of this age. Mobile phone-based interventions such as short messaging service (SMS) interventions have been found effective at changing certain behaviours and improving health outcomes. This protocol describes the BRIGHT Trial, investigating the clinical and cost-effectiveness of a behaviour change intervention-classroom-based session (CBS) embedded in the curriculum and a series of SMS delivered to participants twice daily to remind them to brush their teeth, compared to usual curriculum and no SMS-to reduce the prevalence of dental caries in young people from deprived areas., Objectives: To investigate the clinical and cost-effectiveness of a complex intervention to improve the oral health of young people living in deprived areas., Methods/design: This is a school-based, assessor-blinded, two-arm cluster-randomised controlled trial with an internal pilot trial. Overall, the trial will involve approximately 5040 11-13 year olds in 42 schools with a 3-year follow-up. The trial will take place in secondary schools in England, Scotland and Wales. The primary outcome is the presence of carious lesions in permanent teeth at 3 years. Secondary outcomes are: number of carious teeth, frequency of twice-daily toothbrushing, plaque levels, gingivitis, child health-related quality of life and oral health-related quality of life. A cost-utility analysis will be conducted., Discussion: The findings of the trial have implications for embedding oral health interventions into school curricula guidance produced by national bodies, including departments for education and dental public health and guideline-development organisations., Trial Registration: ISRCTN registry, ISRCTN12139369 . Registered on 10 May 2017.

Background: Existing paediatric oral health-related quality of life (OHRQoL) measures are generic instruments designed to evaluate a range of oral conditions. It has been found that disease-specific measures may be more adept at detecting subtle changes which occur following treatment of the condition in question. Furthermore, existing self-report OHRQoL measures have not involved children at all stages of development of the measure. The aim of this study was to develop a caries-specific measure of quality of life for children., Methods: The first stage of the study involved a qualitative enquiry with children, aged 5-16 years, to inform the development of the measure. Children generated the potential items, contributed to item reduction and questionnaire design and participated in the testing of face and content validity. The resulting measure was evaluated in a cross-sectional validation study. Ethical approval was granted for the study., Results: The qualitative study found that children discussed a number of caries-related impacts which affected their daily lives. These were incorporated into a draft measure which was further refined following testing of face and content validity. This resulted in the production of the Caries Impacts and Experiences Questionnaire for Children (CARIES-QC), comprising 16 items and one global question. Two hundred participants with a mean (range) age of 8.1 (5-16) years took part in the further evaluation of CARIES-QC. Four items, which did not fit the Rasch model, were removed from further analysis. The remaining 12 items demonstrated good internal consistency (alpha = 0.9) and the total score showed significant correlations with the number of decayed teeth, presence of pain, pulpal involvement, the Child Perceptions Questionnaire (16-item short form) and the global score (p < 0.01, Spearman's rho)., Conclusion: In conclusion, children's input allowed the development of a valid and reliable child-centred caries-specific quality of life measure. CARIES-QC can now be used to evaluate which interventions for dental caries are most effective in reducing impacts from the child's perspective.

Background: Dental caries has significant impact on children and their families and may necessitate treatment under general anaesthesia (GA). The use of oral health-related quality-of-life (OHRQoL) measures enables evaluation of dental treatment from a patient's perspective., Objective: This systematic review aimed to assess change in OHRQoL in children following treatment under GA for the management of dental caries., Methods: A comprehensive search was conducted to identify articles which were assessed against inclusion criteria before data extraction. Studies involving children under 16 years, having treatment for dental caries under GA, were considered eligible. Included studies were quality assessed., Results: Twenty studies were included, which demonstrated significant heterogeneity. Most studies employed a pre-test-post-test design. All but one study relied on proxy reports of OHRQoL. Only half the studies used instruments validated in the study population. Whereas all studies reported improved OHRQoL overall, some subscales showed changes which were not significant or worsened OHRQoL. The scientific quality of the studies varied considerably., Conclusion: Heterogeneity of included papers limited the conclusions which could be drawn. Treatment under GA appears to result in overall improvements in proxy-reported OHRQoL; however, there is a need for further high-quality studies employing validated, child-reported measures of OHRQoL., (© 2016 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Background: Dental caries affects 60-90% of children across the world and is associated with a variety of negative impacts. Despite its ubiquity, there has been surprisingly little exploration of these impacts from the child's perspective., Aim: The aim was to allow children to describe the impact of dental caries on their daily lives and to describe the terminology they used., Design: Children, aged 5-15 years, with caries experience were purposively sampled from primary and secondary care dental clinics. Focus groups (n = 5) and in-depth interviews (n = 16) were recorded and transcribed verbatim. Data analysis took a narrative approach, and themes were derived from the data using framework analysis., Results: Pain was the main theme to emerge. Within this, three subthemes were identified: impacts related to pain, strategies adopted to reduce pain, and emotional aspects resulting from pain. A second theme was also identified relating to the aesthetic aspects of caries., Conclusion: Children as young as 5 years of age were able to competently discuss their experiences of dental caries. Participants reported a number of impacts affecting various aspects of their lives. These will be incorporated into the future development of a caries-specific measure of oral health-related quality of life., (© 2015 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Background: Caries Impacts and Experiences Questionnaire for Children (CARIES-QC) is a child-centred caries-specific quality of life measure. This study aimed to select, and validate with children, a classification system for a paediatric condition-specific preference-based measure, based on CARIES-QC. Methods: First, a provisional classification system for a preference-based measure based on CARIES-QC was identified using Rasch analysis, psychometric testing, involvement of children and parents, and the developer of CARIES-QC. Second, qualitative, semi-structured 'think aloud' validation interviews were undertaken with a purposive sample of children with dental caries. The interviewer aimed to identify whether items were considered important and easily understood, whether any were overlapping and if any excluded items should be reintroduced. Interview recordings were transcribed verbatim and thematic analysis conducted. Results: Rasch analysis identified poor item spread for the items 'cross' and 'school'. Items relating to eating were correlated and the better performing items were considered for selection. Children expressed some confusion regarding the items 'school' and 'food stuck'. Parent representatives thought that impacts surrounding toothbrushing ('brushing') were encompassed by the item 'hurt'. Five items were selected from CARIES-QC for inclusion in the provisional classification system; 'hurt', 'annoy', 'carefully', 'kept awake' and 'cried'. Validation interviews were conducted with 20 children aged 5–16 years old. Participants thought the questionnaire was straightforward and covered a range of impacts. Children thought an item about certain foods being 'hard to eat' was more relevant than one about having to eat more carefully because of their teeth and so the 'carefully' item was replaced with 'hard to eat'. Conclusion: Following child-centred modification, the preliminary five-item classification system is considered valid and suitable for use in a valuation survey. The innovative child-centred methods used to both identify and validate the classification system can be applied in the development of other preference-based measures. [ABSTRACT FROM AUTHOR]

Dental caries has significant negative impacts on the lives of children and young people. Whilst the impacts on children's oral health-related quality of life (OHRQoL) have been increasingly investigated, the effect on children's overall wellbeing remains largely unknown. Data were obtained from a survey conducted across four cities in the Netherlands. Children and their parents completed a series of questionnaires, which included Dutch versions of a caries-specific pediatric measure of OHRQoL (CARIES-QC-NL) and a generic pediatric health utility measure (CHU9D-NL). The participating children underwent dental examinations to determine their caries status. A total of 486 11-year-old children participated in the study, of which 184 had caries experience (38%). The mean number of decayed, missing and filled teeth (DMFT) was 0.71. The CARIES-QC-NL was found to have statistically significant correlations with the DMFT and CHU9D-NL. There were no statistically significant correlations between the CHU9D and the clinical variables. The CARIES-QC-NL had acceptable internal consistency and construct validity in this population despite the low prevalence of active caries. A relationship was demonstrated between OHRQoL and generic wellbeing in this population. Despite this, the CHU9D did not show any correlation with the clinical data, which may limit its application in studies of the impact of dental caries. [ABSTRACT FROM AUTHOR]

Comparing oral health-related quality of life (OHRQoL) measures can facilitate selecting the most appropriate one for a particular research question/setting. Three child OHRQoL measures Child Perceptions Questionnaire (CPQ11–14), the Child Oral Health Impact Profile (COHIP) and the Caries Impacts and Experiences Questionnaire for Children (CARIES-QC) were used with 335 10- to 13-year-old participants in a supervised tooth-brushing programme in New Zealand. The use of global questions enabled their validity to be examined. Assessments were conducted at baseline and after 12 months. All three measures had acceptable internal consistency reliability. There were moderate, positive correlations among their scores, and all showed differences in the impact of dental caries on OHRQoL, with children with the highest caries experience having the highest scale scores. Effect sizes were used to assess meaningful change. The CPQ11–14 and the CARIES-QC showed meaningful change. The COHIP-SF score showed no meaningful change. Among children reporting improved OHRQoL, baseline and follow-up scores differed significantly for the CPQ11–14 and CARIES-QC measures, although not for the COHIP-SF. The three scales were broadly similar in their conceptual basis, reliability and validity, but responsiveness of the COHIP-SF was questionable, and the need to compute two different scores for the CARIES-QC meant that its administrative burden was considerably greater than for the other two measures. Replication and use of alternative approaches to measuring meaningful change are suggested. [ABSTRACT FROM AUTHOR]