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Marginalized zero-inflated count regression models have recently been introduced for the statistical analysis of dental caries indices and other zero-inflated count data as alternatives to traditional zero-inflated and hurdle models. Unlike the standard approaches, the marginalized models directly estimate overall exposure or treatment effects by relating covariates to the marginal mean count. This article discusses model interpretation and model class choice according to the research question being addressed in caries research. Two data sets, one consisting of fictional dmft counts in 2 groups and the other on DMFS among schoolchildren from a randomized clinical trial comparing 3 toothpaste formulations to prevent incident dental caries, are analyzed with negative binomial hurdle, zero-inflated negative binomial, and marginalized zero-inflated negative binomial models. In the first example, estimates of treatment effects vary according to the type of incidence rate ratio (IRR) estimated by the model. Estimates of IRRs in the analysis of the randomized clinical trial were similar despite their distinctive interpretations. The choice of statistical model class should match the study's purpose, while accounting for the broad decline in children's caries experience, such that dmft and DMFS indices more frequently generate zero counts. Marginalized (marginal mean) models for zero-inflated count data should be considered for direct assessment of exposure effects on the marginal mean dental caries count in the presence of high frequencies of zero counts., (© 2017 S. Karger AG, Basel.)

Sometimes there is interest in a dichotomized outcome indicating whether a count variable is positive or zero. Under this scenario, the application of ordinary logistic regression may result in efficiency loss, which is quantifiable under an assumed model for the counts. In such situations, a shared-parameter hurdle model is investigated for more efficient estimation of regression parameters relating to overall effects of covariates on the dichotomous outcome, while handling count data with many zeroes. One model part provides a logistic regression containing marginal log odds ratio effects of primary interest, while an ancillary model part describes the mean count of a Poisson or negative binomial process in terms of nuisance regression parameters. Asymptotic efficiency of the logistic model parameter estimators of the two-part models is evaluated with respect to ordinary logistic regression. Simulations are used to assess the properties of the models with respect to power and Type I error, the latter investigated under both misspecified and correctly specified models. The methods are applied to data from a randomized clinical trial of three toothpaste formulations to prevent incident dental caries in a large population of Scottish schoolchildren., (© The Author(s) 2014.)

Background: Dental caries remains the most prevalent chronic condition in children and a major contributor to poor general health. There is ample evidence of a skewed distribution of oral health, with a small proportion of children in the population bearing the majority of the burden of the disease. This minority group is comprised disproportionately of socioeconomically disadvantaged children. An in-depth longitudinal study is needed to better understand the determinants of child oral health, in order to support effective evidence-based policies and interventions in improving child oral health. The aim of the Study of Mothers' and Infants' Life Events Affecting Oral Health (SMILE) project is to identify and evaluate the relative importance and timing of critical factors that shape the oral health of young children and then to seek to evaluate those factors in their inter-relationship with socioeconomic influences., Methods/design: This investigation will apply an observational prospective study design to a cohort of socioeconomically-diverse South Australian newborns and their mothers, intensively following these dyads as the children grow to toddler age. Mothers of newborn children will be invited to participate in the study in the early post-partum period. At enrolment, data will be collected on parental socioeconomic status, mothers' general and dental health conditions, details of the pregnancy, infant feeding practice and parental health behaviours and practices. Data on diet and feeding practices, oral health behaviours and practices, and dental visiting patterns will be collected at 3, 6, 12 and 24 months of age. When children turn 24-30 months, the children and their mothers/primary care givers will be invited to an oral examination to record oral health status. Anthropometric assessment will also be conducted., Discussion: This prospective cohort study will examine a wide range of determinants influencing child oral health and related general conditions such as overweight. It will lead to the evaluation of the inter-relationship among main influences and their relative effect on child oral health. The study findings will provide high level evidence of pathways through which socio-environmental factors impact child oral health. It will also provide an opportunity to examine the relationship between oral health and childhood overweight.

Over the past 5-10 years, zero-inflated (ZI) count regression models have been increasingly applied to the analysis of dental caries indices (e.g. DMFT, dfms). The main reason for that is linked to the broad decline in children's caries experience, such that dmf and DMF indices more frequently generate low or even zero counts. This article specifically reviews the application of ZI Poisson and ZI negative binomial regression models to dental caries, with emphasis on the description of the models and the interpretation of fitted model results given the study goals. The review finds that interpretations provided in the published caries research are often imprecise or inadvertently misleading, particularly with respect to failing to discriminate between inference for the class of susceptible persons defined by such models and inference for the sampled population in terms of overall exposure effects. Recommendations are provided to enhance the use as well as the interpretation and reporting of results of count regression models when applied to epidemiological studies of dental caries., (Copyright © 2012 S. Karger AG, Basel.)

Background: In this article, the authors present evidence-based clinical recommendations regarding the use of nonfluoride caries preventive agents. The recommendations were developed by an expert panel convened by the American Dental Association (ADA)Council on Scientific Affairs. The panel addressed several questions regarding the efficacy of nonfluoride agents in reducing the incidence of caries and arresting or reversing the progression of caries., Types of Studies Reviewed: A panel of experts convened by the ADA Council on Scientific Affairs, in collaboration with ADA Division of Science staff, conducted a MEDLINE search to identify all randomized and nonrandomized clinical studies regarding the use of non fluoride caries-preventive agents., Results: The panel reviewed evidence from 50 randomized controlled trials and 15 nonrandomized studies to assess the efficacy of various nonfluoride caries-preventive agents., Clinical Implications: The panel concluded that certain nonfluoride agents may provide some benefit as adjunctive therapies in children and adults at higher risk of developing caries. These recommendations are presented as a resource for dentists to consider in the clinical decision-making process. As part of the evidence based approach to care, these clinical recommendations should be integrated with the practitioner’s professional judgment and the patient’s needs and preferences.

The ultimate purpose of both dental industry and dental education is to improve the oral health of the public. This report provides background information on the different roles and objectives of the dental industry and dental education communities, the different operating environment of each sector and also areas of common interest where collaboration will be of mutual benefit. The report addresses five areas for potential collaboration between the dental industry and the dental education communities: 1. Contribution to joint activities. 2. Effectiveness and efficiency. 3. Workforce needs. 4. Middle- and low-income countries. 5. The future of International Federation of Dental Educators and Associations (IFDEA). The traditional areas of support and their limitations that have been provided by industry are outlined in the report and some new approaches for collaboration are considered. Industry-based research has been an important factor in developing new products and technologies and in promoting oral health. However there is a need to facilitate the introduction of these developments at an early stage in the education process. Industry has to operate in an efficient manner to remain competitive and maximise its returns and therefore survive. The academic sector operates in a different environment and under different governance structures; although some trends are noted towards adoption of greater efficiency and financial accountability similar to industry. Opportunities to jointly develop best business practices should be explored. Industry has responded well to the oral health needs of the public through the development of new products and technologies. The education community needs to respond in a similar way by examining different healthcare delivery models worldwide and developing programmes to train members of the dental team to cater for future needs and demands of communities in different regions of the world. The reputation of industry-based scientists and clinicians is high, and their role in contributing to the dental education process in practical ways needs to be explored and further developed. Closer relationships between industry scientists and faculty and students could assist industrys need and desire to develop new technologies for the broader dental care system. The corporate sector can play a key role in the future success of IFDEA by providing support and expertise in developing areas such as regional leadership institutes, a Global Faculty and Network and in collaborating in developing continuing education programmes as well as involvement in its governance. Thirteen recommendations are made in the report. These are considered to be important initial steps in developing the already strong relationship between the education and corporate sectors. Partnership and collaborating more effectively along the lines suggested should, almost certainly, generate mutually beneficial outcomes, whilst serving over the long term to elevate the publics oral health status on a global basis.

The history of clinical trials would include events in 1747 on board the Salisbury, a British Navy vessel at sea with 12 seamen critically ill with scurvy. Involving these 12 sailors in a study, an officer on board by the name of Lind evaluated six potential treatments for scurvy, and rapidly reached the conclusion that daily consumption of citrus fruits returned the men fit for duty in approximately six days (Bull, 1959). The concept of experimental randomization was first developed by Sir R.A. Fisher (1925, 1926), and the method was introduced to medical research via a study of tuberculosis treatment by Amberson and co-workers (1931), who randomized 24 TB patients into two groups, one to receive the experimental therapy, the other serving as the control. Amberson et al. also incorporated the concept of blinding into their study. Sir Austin Bradford Hill codified and built on the principles of scientific experimentation developed by Fisher, and introduced the use of random numbers in the allocation of patients in the British Medical Research Council (1948) study of the effect of streptomycin in the treatment of tuberculosis (Daniels and Hill, 1952; Hill, 1952). The first applications of clinical trial methodology for testing interventions on dental, oral, and maxillofacial diseases and conditions are more difficult to determine. For dental caries prevention, however, Chilton and Fertig (1958) and Slack and Martin (1964) were certainly among the early caries clinical trial pioneers. As clinical trials have come into the mainstream of clinical research in medicine and dentistry, a great deal of developmental work has focused on their methodological enhancement. The most successful of these efforts have come from fruitful, ongoing collaborations among clinician investigators, biostatisticians, data management specialists, biomedical ethicists, and others with an academic interest in clinical trial design and utilization. During the past 25 years, the emergence of systematic reviews and the evidence-based medicine (EBM) movement have also contributed significantly to the increasing reliance on randomized clinical trial outcomes for the advancement of better clinical practice (Richards et al., 1997; Straus and Sackett, 1998; www.cochrane.org/cochrane/ccbroch.htm#BDL, 2002).

This paper reviews the current place of dentifrices, toothbrushes and rinses in the personal dental products market using data from the United States as an illustration. The clinical evolution of fluoride in dentifrices and rinses is briefly outlined, as is the changing view of the balance between the systemic and topical effects of the element on preventing dental caries. Issues involved in the current scientific arena are described as are issues related to caries trends and preventive technologies that deserve attention in the future.

The purpose of this analysis is to compare three different statistical models for predicting children likely to be at risk of developing dental caries over a 3-yr period. Data are based on 4117 children who participated in the University of North Carolina Caries Risk Assessment Study, a longitudinal study conducted in the Aiken, South Carolina, and Portland, Maine areas. The three models differed with respect to either the types of variables included or the definition of disease outcome. The two "Prediction" models included both risk factor variables thought to cause dental caries and indicator variables that are associated with dental caries, but are not thought to be causal for the disease. The "Etiologic" model included only etiologic factors as variables. A dichotomous outcome measure--none or any 3-yr increment, was used in the "Any Risk Etiologic model" and the "Any Risk Prediction Model". Another outcome, based on a gradient measure of disease, was used in the "High Risk Prediction Model". The variables that are significant in these models vary across grades and sites, but are more consistent among the Etiologic model than the Predictor models. However, among the three sets of models, the Any Risk Prediction Models have the highest sensitivity and positive predictive values, whereas the High Risk Prediction Models have the highest specificity and negative predictive values. Considerations in determining model preference are discussed.

The University of North Carolina caries risk assessment was conducted between 1986 and 1989 with 5000 children initially in grades 1 and 5 from low fluoride sites in South Carolina and Maine. Clinical, microbiologic, behavioral, and demographic factors served as independent variables used in logistic multiple regression models to determine the predicted caries risk classification of each child. The 3-yr DMFS increment of each child was the dependent variable, and the 20-25% of those in each cohort with the highest increment were considered the high risk group. Sensitivity and specificity values averaged 0.60 and 0.83 respectively, indicating the misclassification of substantial numbers of children. This paper reports analysis of the DMFS increments of the misclassified children. The majority of children had DMFS increments within one or two surfaces of the classification cut points. Many false negative children had increments composed entirely of filled surfaces, often of minimal extent and without evidence of previous decay. Many false positive children had increments composed of decayed surfaces and would have benefitted from being identified as high risk and assigned to a preventive program. Other false positive children had sealants placed after the baseline examination that undoubtedly reduced their true increment. It is concluded that the consequences of misclassification are not serious for most children in this study.

Over 4000 first and fifth grade children from the areas surrounding Aiken, South Carolina, and Portland, Maine, participated in a 4-yr study to develop caries risk assessment models. The predictors used at baseline included detailed clinical examinations, salivary microbiological tests, and sociodemographic and dental behavior data. Mean 3-yr caries increments in South Carolina were twice those in Maine. For the four risk assessment models (two grade cohorts at two sites) specificity values averaged 0.83 and sensitivity values averaged 0.60. Clinical predictors such as prior DMFS, pit and fissure morphology, and predicted caries risk status were the major contributors to the models.

This paper seeks to achieve four goals, each of which forms the basis for a section in the presentation. First, the rationale of risk assessment is fully described. In this section, some of the necessary conditions are identified that make disease prediction worth pursuing. The second section discusses some essential background to the understanding of risk assessment in dentistry. In this segment, attention is focused on population-based and individual-based perspectives, alternative approaches to expressing health risk, and methods for comparing the predictive accuracy of alternative risk assessment models. The third section of the paper develops a conceptual framework for risk assessment in dentistry. Particular emphasis is devoted to the identification of risk factors and their incorporation into alternative statistical models. In the fourth section, empirical data are offered by which certain comparisons of the alternative risk models can be drawn. The paper concludes with a discussion that emphasizes data and technical limitations, speculates on future applications, and suggests new avenues for research.

The temporal relation between a declining fluorosis gradient and an abrupt downward shift in community drinking water fluoride concentration was evaluated through multiple correlation analysis to determine the critical time frame during which developing maxillary central incisors are most susceptible to fluoride challenge. Fluorosis data were scrutinized through a time-related series of epidemiologic "windows" or time frames of varying lengths. The placement of these time frames was in turn related to the presumed start of enamel mineralization (at birth), and ranged from zero to 60 months later. In this way, the susceptibility of developing enamel to changes in water fluoride concentration was localized. The greatest risk was associated with a four-month critical period commencing at 22 months following birth. The risk of fluorosis from exposures to a fluoride challenge acting during shorter periods was better localized than risk associated with longer exposures. We concluded (1) that human maxillary central incisors are most susceptible to fluorosis during a critical period of as little as four months' duration, commencing at 22 months of age; and (2) that for these incisors, fluoride exposure during the months prior to this period carries less risk than continued exposure for up to 36 months beyond this critical time.

Caries prediction by Classification And Regression Tree (CART) analysis is an appropriate and powerful alternative or complement to the commonly used classification methods of logistic regression and discriminant analysis, both parametric and nonparametric. The binary classification tree method discussed in this article is designed for complex data and does not require assumptions about the predictor variables or about the presence or absence of interactions among the predictor variables. Furthermore, the results give insight into the structures and interactions in the data and are easy to interpret and apply. In preliminary applications of the CART algorithms to data from The University of North Carolina Caries Risk Assessment Study, the method produced prediction rules having sensitivities and specificities that were similar to or slightly better than those associated with logistic and discriminant analyses. The classification trees constructed tended to involve far fewer predictor variables than required for adequate logistic and discriminant models. For example, for first-grade children in Aiken, South Carolina, nine variables were used to define a prediction rule having 64% sensitivity and 86% specificity. Ten-fold cross-validation estimates for future data were 58% and 79%, respectively. For first-grade children in Portland, Maine, two variables were used to define a prediction rule having 62% sensitivity and 77% specificity. The cross-validation estimates for future data were 58% and 78%, respectively. A brief, and previously unavailable, explanation of the CART method is given for the special case of a dichotomous outcome variable.

The baseline caries experienced of approximately 5,000 children in South Carolina and Maine was used as the dependent variable in caries risk assessment analyses. Clinical, microbiologic, and demographic factors served as independent variables in a multivariate relationship to caries through regression and discriminant function analyses. Four factors--number of dental visits by the child in the past year, presence of white spot lesions, and both the urgency of need for restorative care and the future caries increment predicted by the examiner--associated significantly and consistently with caries prevalence in primary and permanent teeth of first and fifth graders at both study sites. Several factors associated significantly with caries prevalence at only one site or grade within a site, suggesting that wide applicability of a specific caries risk assessment model may be limited. In these analyses, sensitivity ranged from .60 to .72 and specificity varied from .86 to .91 in the four grade-site groups. The ultimate goal of this longitudinal study is to identify highly caries-prone children in time to prevent the occurrence of a future caries increment. Although the lack of consistent association of many variables, including microbiologic factors, with baseline caries prevalence was unexpected, it is expected that some of these variables will contribute predictive power in the prospective study.

The drinking water fluoride concentration in Hong Kong was reduced by about 0.2 ppm in June 1978. This study was undertaken to determine whether the prevailing level of dental fluorosis was affected by such a minor change. Cohorts of children (N = 1,062) aged seven to 12 years, who were born both before and after the fluoride reduction, were examined clinically using Dean's fluorosis index. Based on upper right central incisors, dental fluorosis prevalence decreased from 64 to 47 percent and the community fluorosis index decreased from 1.01 to 0.75 (P less than .01). Thus, dental fluorosis was reduced, although the reduction in water fluoride concentration was not sufficient to achieve the minimal fluorosis level that Dean associated with a fluoride concentration optimal for caries prevention. Variation in dental fluorosis has been reported previously to result from marked sudden changes, during tooth formative years, to drinking water fluoride concentration. This study confirms preliminary findings that variation in dental fluorosis arising from minor changes to the fluoride level in drinking water is also measurable.

One hundred ninety-two subjects completed a clinical trial to determine the effects of seven dentifrice formulations on calculus inhibition. The double-blind study involved a ten-day control phase and a ten-day experimental phase. For the control phase, subjects were evaluated for calculus present, received a prophylaxis and had pre-weighed mylar strips attached to the lingual surfaces of the mandibular incisors to harvest mineral deposits. Subjects were then assigned the placebo dentifrice for unsupervised twice-daily use and were required to report once a day for a supervised mouthrinse using a 1:3 dilution of the dentrifice. The experimental phase was identical except that subjects were allocated the experimental dentifices using a stratified random assignment based on age, gender and the initial presence of calculus. Simple linear regression analyses of the dry and ash log weights obtained from the strips were performed. The results showed no statistically significant differences among the test products; however, two formulations containing zinc citrate showed some calculus inhibition-potential suggesting that further research and development of such products may be warranted.

Baseline clinical dental examinations were conducted on 5,233 children in grades 1 or 5 from the areas surrounding Aiken, SC, and Portland, ME, as part of a longitudinal study being conducted to predict children at high risk to dental caries. Mean caries levels in the Aiken area were nearly twice those of the Portland area. Black children experienced slightly more disease than whites. In addition to lower levels of caries experience, Portland children also had more treatment needs met, as indicated by higher filled ratio scores.

Recent studies indicate that the prevalence of very mild to moderate dental fluorosis, as classified by Dean, has increased relative to that found in earlier investigations. To date, fluoridated water, fluoride supplements, the diet, fluoride dentifrices, and other topical fluoride applications have been identified as sources of systemic fluoride. Recent evidence suggests that there is a strong association between mild to moderate enamel fluorosis and the use of fluoride supplements during early childhood, and that the presently recommended supplementation schedule for U.S. children above the age of 2 years may be too high. Evidence also suggests that there is a strong association between fluoride dentifrice use during early childhood and enamel fluorosis in fluoridated populations. These findings support the need for a careful review of existing supplementation schedules and early oral hygiene practices. There is a pressing need for additional analytical epidemiological studies to confirm existing findings and to determine whether other fluoride sources may be associated with enamel fluorosis. Further, since exposure to combinations of individual risk factors has been shown to carry more than merely an additive increase in the risk of fluorosis, these studies must be multifactorial in design. There is also a need for more fluorosis prevalence and severity data to be gathered, so that the development of enamel fluorosis as a public health problem can be assessed, and so that the success of measures implemented to maximize efficacy while minimizing unwanted side-effects can be monitored.

For a comparative study of root caries, 502 adult lifelong residents of a naturally fluoridated community (1.6 ppm F) and 465 such residents of a nearby, comparable nonfluoridated community (0.2 ppm F) were examined. Substantially fewer carious lesions were found among adults in the fluoridated community relative to the nonfluoridated community. This was observed in virtually all age- and gender-specific groups. Given a cross-sectional design and considering only exposed root surfaces, root caries was related to age. In addition, the data from this study show that the number of root caries lesions is underestimated but that root caries prevalence is overestimated by the standard Root Caries Index (RCI). A less restrictive form of the RCI may lead to more valid estimation of root caries prevalence.

In recent years, tremendous strides have been made in understanding the etiology of gingivitis. This increase in knowledge has come, for the most part, from basic research in oral microbiology, immunology, histology and pathology. Over the past decade, less progress has been made in further refining the epidemiological relationships between gingivitis and various host and environmental factors. The major restraint has been the great difficulty in reliably measuring gingival inflammation. This problem has resulted in great inter- and intra-study variation in diagnosing the prevalence and severity of gingivitis in human populations. Consequently, it is almost impossible to estimate longitudinal trends in gingivitis and it is nearly as difficult to make comparisons among different population groups studied by different examiners. Nevertheless, by focusing on the most apparent and robust epidemiological relationships, an instructive overview of the epidemiology of gingivitis can be gained. A number of host and environmental factors have been studied in relation to gingivitis and some of these will be reviewed. With respect to age, there is general concensus that marginal gingivitis begins in early childhood, increases in prevalence and severity to the early teenage years, thereafter subsiding slightly and leveling off for the remainder of the second decade of life. Gingivitis during the adult period is much more difficult to characterize due to paucity of data. Estimates of the general prevalence of adult gingivitis vary from approximately 50 to 100% for dentate subjects. In terms of gingivitis prevalence, the dentate elderly do not deviate appreciably from the general adult pattern. When adjusted for cohort effects, gingival disease appears to be on the decline.(ABSTRACT TRUNCATED AT 400 WORDS)

In 1982, twenty-four pairs of captive American kestrels (Falco sparverius) were forced to renest by removal of their first clutches 6 days after their completion. Immediately following, each of three groups of eight pairs was randomly assigned to one of three daily dietary regimes for 10 days: (1) three 1-day old cockerels with background levels of F(-) (62.4+/-51ppm, mean+/-SD) in their femurae, (2) two 10-day old cockerels with 4512+/-810ppm of F(-) in their femurae, (3) two 10-day old cockerels with 7690+/-417ppm of F(-) in their femurae. Fluoride levels in femurae of treated kestrels were significantly (P<0.0025) higher than those of control birds. Clutch sizes tended to be smaller as more fluoride was added to the diet, but not significantly so, due to an increase of the variance in the treatment group. Per cent fertility and per cent hatchability were not significantly affected by treatment. The fluoride content in eggshells in the fluoride-treated groups differed significantly from those of the control group (P<0.001).

This has been a necessarily cursory overview of three types of clinical dental caries studies: the dental survey, the randomized clinical trial, and the non-randomized comparative study. Each of these studies may be used in its appropriate place, although only the survey and the randomized clinical trial are well-grounded in scientific theory. In general, the dental survey is well-suited to gathering basic cross-sectional data on dental caries, data that serve a variety of important practical and scientific interests in the dental care system. Clinical trials and non-randomized studies are applied in evaluating a variety of therapies for dental caries. Of the two, the randomized clinical trial is by far the more powerful. As a result, the clinical trial has found a central place in dentistry. The contributions that past and present clinical caries trials have made to dental health are quite evident to most observers. It is virtually inescapable that well-conducted clinical caries trials will make even more significant contributions to dental practice in the future, thereby further improving the oral health of all.

The purpose of this study was to demonstrate the effectiveness of two fluoride varnishes (Duraphat and Fluor Protector) in the prevention of dental caries in children residing in a non-fluoridated community. At baseline, 787 grade one children (6-7-yr old) were examined and randomly allocated into a control and two treatment groups. At 20 months, 703 children remained in the study. The mean baseline caries experience and the mean number of permanent teeth present at 20 months were not significantly different among the treatment and control groups. The mean DMFS increments after 20 months were 1.70, 1.73 and 2.02 for Fluor-Protector, Duraphat and control groups respectively (% reductions of 15.8 and 14.4 for Fluor-Protector and Duraphat groups). The mean dfs increments for primary molars after 20 months were 1.56, 1.62 and 1.74 for Fluor-Protector, Duraphat and control groups respectively (% reductions of 10 for Fluor-Protector and 7 for Duraphat).

This study assesses the comparative effectiveness of three types of dental floss and toothbrushing in reducing interproximal bleeding sites, measured by stimulation with wooden interdental cleaners using the interdental bleeding index assessment method. The 119 adult subjects with gingival inflammation were randomly assigned to one of four groups at the beginning of a supervised 2 week clinical trial. The toothbrushing only group achieved a 35% reduction in bleeding sites and the three flossing groups all demonstrated dramatic reductions of about 67%. The three varieties of dental flosses were about equally effective in reducing interproximal bleeding and doubly effective as toothbrushing alone. Compared to probing, the interdental bleeding index method is considered a simplified method of assessing interproximal gingival inflammation.

Studies of dental preventive interventions often do not incorporate a concurrent, longitudinal control group in their study design. The existence of a secular decline in dental caries during the conduct of these studies may result in an overstatement of the effectiveness of the preventive intervention. Results of a recent large caries preventive study are analyzed using both a concurrent, longitudinal control group and an historical comparison group to demonstrate this effect. Differences in effectiveness of preventive procedures determined using the two types of control groups are sufficient to suggest a probable misinterpretation of results of studies using only historical comparisons.

This paper presents the comparative effectiveness of fluoride mouthrinse (FMR) on high and low caries forming children after a 4-yr exposure to weekly rinse beginning in the first grade. Over 1200 grade 1 children drawn from both fluoride deficient and fluoridated sites were divided into treatment and concurrent, longitudinal control groups. After 4 yr these children were stratified according to caries increment; those above the 75th percentile were considered high caries formers, all others were designated low caries formers. After adjustment of the mean increments for differences in SES, age, race, and sex in rinse and control groups, high caries formers (approximately 25% of the children) in the rinse and control groups in fluoride deficient areas showed increments of 7.00 and 7.79 surfaces, respectively, indicating a savings of 0.79 surfaces. Low caries formers (approximately 75% of the children) demonstrated increments of 1.11 DMFS in the rinse group and 1.40 in the control group (savings 0.29 DMFS). The pattern was quite similar for children in fluoridated areas except that the increments, as well as the savings realized, were lower. The results raise questions as to the practical effectiveness of school based FMR programs even for high caries forming children.