Effectiveness of Sealants on Molars

Not Applicable

Completed

• Conditions: Tooth Decay
• Interventions: Other: decayed tooth surfaces

• Registration Number: NCT02896088
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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

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:

1. To assess the prevalence and caries attack sites at the end of each year

2. Estimate the retention rate (partial or complete) of the AS during the study

3. Determine the cost savings of treatment during the trial period

Study Timeline

• Study Start: 2016-05-01
• Study First Submitted: 2016-09-06
• Study First Submitted QC: 2016-09-06
• Study First Posted: 2016-09-12
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-30
• Status Verified: 2020-11
• Last Update Submitted: 2022-08-10
• Last Update Posted: 2022-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
control tooth groups	decayed tooth surfaces	control tooth groups
test tooth groups	decayed tooth surfaces	test tooth groups

Primary Outcome Measures

Name	Time	Method
decayed tooth surfaces	1 year	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.

Secondary Outcome Measures

Name	Time	Method
decayed tooth surfaces	3years	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.

Trial Locations

Locations (1)

MOULIS; 🇫🇷 Montpellier, France