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

Primary Purpose

Enamel Lesions, Dental Caries

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
air abrasion
sono abrasion
dental bur
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Enamel Lesions focused on measuring suspected caries, initial enamel lesions

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU
  • APHP

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

dental bur versus air abrasion

sono abrasion versus dental bur

air abrasion versus sono abrasion

Arm Description

1 tooth prepared with air abrasion versus one prepared tooth with dental bur

1 tooth prepared with sono abrasion ans 1 tooth prepared with dental bur

1 tooth prepared with air abrasion versus 1 tooth prepared with sono abrasion

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 4, 2013
Last Updated
April 22, 2016
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT02594020
Brief Title
Comparison of Different Methods of Enamel Preparation Before Pit and Fissure Sealants
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enamel Lesions, Dental Caries
Keywords
suspected caries, initial enamel lesions

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dental bur versus air abrasion
Arm Type
Other
Arm Description
1 tooth prepared with air abrasion versus one prepared tooth with dental bur
Arm Title
sono abrasion versus dental bur
Arm Type
Other
Arm Description
1 tooth prepared with sono abrasion ans 1 tooth prepared with dental bur
Arm Title
air abrasion versus sono abrasion
Arm Type
Other
Arm Description
1 tooth prepared with air abrasion versus 1 tooth prepared with sono abrasion
Intervention Type
Procedure
Intervention Name(s)
air abrasion
Intervention Description
already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin
Intervention Type
Procedure
Intervention Name(s)
sono abrasion
Intervention Description
already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin
Intervention Type
Procedure
Intervention Name(s)
dental bur
Intervention Description
already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin
Primary Outcome Measure Information:
Title
observation of quality of treatment
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
APHP
City
Paris
ZIP/Postal Code
75000
Country
France

12. IPD Sharing Statement

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

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