Caries, Dental Clinical Trial
Official title:
Effectiveness of Pit and Fissure Sealants in the Prevention of Dental Caries
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.
Status | Completed |
Enrollment | 400 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 15 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Universitaire de Nice | Nice |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nice |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Caries development | every six month during 2 years | No | |
Secondary | CAOD | every six months during 2 years | No | |
Secondary | Retention sealing of furrows (grooves) | every 6 months during 2 years | No |
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