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

April 22, 2016 updated by: Centre Hospitalier Universitaire de Nice
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06000
        • CHU
      • Paris, France, 75000
        • APHP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: dental bur versus air abrasion
1 tooth prepared with air abrasion versus one prepared tooth with dental bur
Procedure: air abrasion
already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin
Procedure: dental bur
already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin
Other: sono abrasion versus dental bur
1 tooth prepared with sono abrasion ans 1 tooth prepared with dental bur
Procedure: dental bur
already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin
Procedure: sono abrasion
already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin
Other: air abrasion versus sono abrasion
1 tooth prepared with air abrasion versus 1 tooth prepared with sono abrasion
Procedure: air abrasion
already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin
Procedure: sono abrasion
already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
observation of quality of treatment
Time Frame: 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 4, 2013

First Submitted That Met QC Criteria

October 30, 2015

First Posted (Estimate)

November 1, 2015

Study Record Updates

Last Update Posted (Estimate)

April 25, 2016

Last Update Submitted That Met QC Criteria

April 22, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-PP-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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