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NCT02594020 Clinical Trial

Comparison of Different Methods of Enamel Preparation Before Pit and Fissure Sealants

Dental Caries Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02594020
Other study ID # 08-PP-09
Secondary ID
Status Completed
Phase N/A
First received June 4, 2013
Last updated April 22, 2016
Start date June 2008
Est. completion date December 2015

Study information
Verified date September 2015
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority france: CPP SUD MEDITERRANNEE 5
Study type Interventional

Clinical Trial Summary

This study concerns the prevention of dental caries by sealing pits and fissures of permanent molars with a photopolymerizable resin. It must compare these three techniques Microdentisty (air abrasion, abrasion and sound using small cutters) usually used to prepare micro cavities in the enamel and / or the outer third of the dentin. These three commonly used techniques have never been compared by retaining as endpoint retention of sealant. These techniques are painless and do not require local anesthesia.

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date December 2015
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Affiliated with the Social Security

- Attendance at inspections

- Subject to high individual risk of caries

- Subjects with at least two pairs of molars and contralateral counterparts with the initial lesions of enamel (pits and fissures colored) or suspected of dentine caries (not highlighted by two clinical and radiographic examination usual)

Exclusion Criteria:

- Molar inaccessible, closed, sealed, or decayed (reaching the dentine

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• air abrasion
already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin
• sono abrasion
already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin
• dental bur
already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin

Locations
Country Name City State
France CHU Nice
France APHP Paris

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary observation of quality of treatment Compare enamel preparation techniques of air abrasion and sound abrasion technique enameloplasty (pits and fissures extended to the dental bur) the more conventionally used to identify the most effective as using endpoint retention of material sealing of pits and fissures. 2 years No
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