- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02594020
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
-
-
-
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
|
already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin
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
|
already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin
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
|
already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin
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.
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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