Effectiveness of Pit and Fissure Sealants in the Prevention of Dental Caries

Study Overview
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Brief Summary
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This randomized clinical trial is aimed at testing the efficacy of pit and fissure sealants, in a current environmental context different from that of the seventies and eighties. It has a split mouth design. 4OO subjects are included and the duration of follow up is 2 years.

Detailed Description
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This randomized clinical trial is aimed at testing the efficacy of pit and fissure sealants, in a current environmental context different from that of the seventies and eighties. This study assesses the cost-effectiveness of sealants according to the individual caries risk. This study takes place in Nice, Marseille and Paris (France) and the patients are to be enrolled both in the dental hospitals and in the private practice. In the hospitals, the subjects are recruited directly by the headmasters of the pediatric dentistry or public health departments in the three dental schools. In private practice, the head of the department of pediatric dentistry and / or public health dentistry, of each dental school chooses 4 to 6 private practitioners who are used to place dental sealants in their daily practice. They recruit the subjects among their own patients. The type of study corresponds to randomized clinical trial (Split mouth design) in which the tooth is the statistical unit (one pair of molars considered for each included patient). This study has a direct benefit for individuals. The number of necessary subjects is 328; the sample size is 400. The follow-up duration is 2 years. The treatment is a pit and fissure sealant on one randomized tooth by pair of permanent molars (Split mouth design). Sealant material is set up in accordance with the usual practice of each practitioner. Occlusal exams are conducted every 6 months. The effectiveness of dental sealants and the retention of sealing materials are statistically analyzed according to both the individual caries risk and the clinical protocol

Official Title
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Effectiveness of Pit and Fissure Sealants in the Prevention of Dental Caries

Conditions
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Caries, Dental

Intervention / Treatment
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* Other: pit and fissure sealant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: child over 6 years old patient with at least one carie patient with at least one pair of permanent molar: healthy or with equivalent injuries Exclusion Criteria: not cooperating in care not speaking french or english

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 15 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>pit and fissure sealant on one randomized tooth by pair of permanent molar | Other: pit and fissure sealant<br>* pit and fissure sealant on one randomized tooth by pair of permanent molar<br>|
| No Intervention: 2<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries development |  | every six month during 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAOD |  | every six months during 2 years | 
| Retention sealing of furrows (grooves) |  | every 6 months during 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pit, sealant, child, over, 6 years old, least