Effectiveness of Sealants on Molars

Study Overview
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Brief Summary
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Currently, the real scope of sealants (AS) is poorly documented in temporary dentition and its effectiveness has not been demonstrated. Yet it seems reasonable that the AS in temporary dentition could slow the specific development of carious lesions in early childhood. In addition, this non-invasive approach could delay the conventional food and thus save financial costs for more complex treatments. Finally, the installation of AS could afford, as demonstrated in adult teeth, lowering the cariogenic bacteria prevalence engaged in the caries process.

Detailed Description
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Currently, the real scope of sealants (AS) is poorly documented in temporary dentition and its effectiveness has not been demonstrated. Yet it seems reasonable that the AS in temporary dentition could slow the specific development of carious lesions in early childhood. In addition, this non-invasive approach could delay the conventional food and thus save financial costs for more complex treatments. Finally, the installation of AS could afford, as demonstrated in adult teeth, lowering the cariogenic bacteria prevalence engaged in the caries process. Main objective: To evaluate the effect of AS on caries incidence in the deciduous dentition obtained over a period of three years, taking into account the risk of caries established initially. Secondary objectives: To assess the prevalence and caries attack sites at the end of each year Estimate the retention rate (partial or complete) of the AS during the study Determine the cost savings of treatment during the trial period

Official Title
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Prevention of Dental Caries in Primary Molars on Sealants

Conditions
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Tooth Decay

Intervention / Treatment
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* Other: decayed tooth surfaces


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children who have at least two pairs (test / control) of healthy molars with occlusal surface or non cavitary initial injury. Children available for a follow-up 3 years Children being affiliated or beneficiary in a health insurance plan Exclusion Criteria: Children involved in other research in the same field Child is exclusion period determined by previous research Children participating in research in the last three months its inclusion Parents do not understand French. Children deprived of liberty. Child participation Refusal Refusal to participate in either of the parents or legal representative

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: test and control tooth groups. Each patient is therefore his own witness
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: test tooth groups<br>test tooth groups | Other: decayed tooth surfaces<br>* The main variable is the number of new decayed tooth surfaces between the end and the beginning of the research. The caries experience will also be evaluated and expressed by the index 'dmfs' (accumulation of decayed tooth surfaces over those missing or filled due to caries). The secondary variable will be the expression of the retention of AS. The comparison of caries incidence between the two groups of teeth (with and without AS) will take into account the membership of the teeth to the same subject by means of the statistical test Chi-McNemar two. Regression models logistics and Poisson regression will be used to test the effect of independent variables on the appearance of new cavities. The Stata statistical software will be used.<br>|
| Other: control tooth groups<br>control tooth groups | Other: decayed tooth surfaces<br>* The main variable is the number of new decayed tooth surfaces between the end and the beginning of the research. The caries experience will also be evaluated and expressed by the index 'dmfs' (accumulation of decayed tooth surfaces over those missing or filled due to caries). The secondary variable will be the expression of the retention of AS. The comparison of caries incidence between the two groups of teeth (with and without AS) will take into account the membership of the teeth to the same subject by means of the statistical test Chi-McNemar two. Regression models logistics and Poisson regression will be used to test the effect of independent variables on the appearance of new cavities. The Stata statistical software will be used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decayed tooth surfaces | The main variable is the number of new decayed tooth surfaces between the end and the beginning of the research. The caries experience will also be evaluated and expressed by the index 'dmfs' (accumulation of decayed tooth surfaces over those missing or filled due to caries). The secondary variable will be the expression of the retention of AS. The comparison of caries incidence between the two groups of teeth (with and without AS) will take into account the membership of the teeth to the same subject by means of the statistical test Chi-McNemar two. Regression models logistics and Poisson regression will be used to test the effect of independent variables on the appearance of new cavities. The Stata statistical software will be used. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decayed tooth surfaces | The main variable is the number of new decayed tooth surfaces between the end and the beginning of the research. The caries experience will also be evaluated and expressed by the index 'dmfs' (accumulation of decayed tooth surfaces over those missing or filled due to caries). The secondary variable will be the expression of the retention of AS. The comparison of caries incidence between the two groups of teeth (with and without AS) will take into account the membership of the teeth to the same subject by means of the statistical test Chi-McNemar two. Regression models logistics and Poisson regression will be used to test the effect of independent variables on the appearance of new cavities. The Stata statistical software will be used. | 2 years | 
| decayed tooth surfaces | The main variable is the number of new decayed tooth surfaces between the end and the beginning of the research. The caries experience will also be evaluated and expressed by the index 'dmfs' (accumulation of decayed tooth surfaces over those missing or filled due to caries). The secondary variable will be the expression of the retention of AS. The comparison of caries incidence between the two groups of teeth (with and without AS) will take into account the membership of the teeth to the same subject by means of the statistical test Chi-McNemar two. Regression models logistics and Poisson regression will be used to test the effect of independent variables on the appearance of new cavities. The Stata statistical software will be used. | 3years |