A clinical trial of the effectiveness of a dental caries prevention

Wed, 10/10/2012 - 13:47 -- admin
TitleA clinical trial of the effectiveness of a dental caries prevention
Publication TypeResearch
Year of Publication2011
AuthorsHarrison R, Véronneau J, Leroux B
Abstract

Background The goal of this cluster randomized trial was to test the effectiveness of a counseling approach, Motivational Interviewing, to control dental caries in young Aboriginal children. Motivational Interviewing, a client-centred, directive counseling style, has not yet been evaluated as an approach for promotion of behaviour change in indigenous communities in remote settings. Methods/design Aboriginal women from the 9 Cree communities in Quebec recruited expectant and new mothers to the trial, administered questionnaires and delivered the counseling to mothers in the test communities. The goal was for mothers to receive the intervention during pregnancy and at their child’s immunization or well-baby visits. The communities were randomly allocated to test or control group by a random “draw” over community radio. Sample size and power were determined based on an anticipated 20% reduction in caries prevalence. Randomization checks were conducted between groups. Data on children’s dental health status and family dental health practices was collected when children were at least 30-months of age. Results In the 5 test and 4 control communities, 272 (131 test; 141 control) of the original target sample size of 309 mothers were recruited over a 2½ year period. Demographic and baseline characteristics were similar for the two groups of mothers. At the end of the trial, 241 participating children had follow-up examinations. The actual mean (SD) number of MI interventions per test mother was 2.7 (1.7), range 0-6. Of the 131 test mothers, 93 (71%) had 2 or more MI sessions and 46 (35%) had 4 or more interventions usually of 15-30 minutes duration. When levels of caries of increased severity were examined, an apparent treatment effect emerged. Percentages of children with caries (untreated or treated) at the level of the dentin or worse were 65% in the control group and only 40% in the test group, which implies an estimated 38% reduction in disease prevalence. However, the assessment of statistical significance of this effect was inconclusive. Results by community suggest that the intervention may have had a caries preventive effect in all but one of the test communities The implementation of the trial in these remote communities, the problems of enlisting dedicated project staff and the unexpected changes in philosophies about research by the territory’s governing body heightened the project’s challenges. Conclusions Overall, the results do not provide compelling evidence for a caries preventive effect of the MI intervention in these Cree communities. Certainly, the overall prevalence of caries in both treatment groups remained alarmingly high. However, there are suggestions that the intervention may have an impact on the extent or severity of disease. These results are not conclusive due to effects of clustering of children within communities and the small number of communities. Undoubtedly our results will be useful for generating specific hypotheses that can be tested in future trials and for informing protocols, approaches and methods in future randomized controlled trials in high-risk and difficult to access communities.

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