NCT02594020

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

November 2, 2015

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 25, 2016

Status Verified

September 1, 2015

Enrollment Period

5.5 years

First QC Date

June 4, 2013

Last Update Submit

April 22, 2016

Conditions

Keywords

suspected cariesinitial enamel lesions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

dental bur versus air abrasion

OTHER

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

Procedure: air abrasionProcedure: dental bur

sono abrasion versus dental bur

OTHER

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

Procedure: sono abrasionProcedure: dental bur

air abrasion versus sono abrasion

OTHER

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

Procedure: air abrasionProcedure: sono abrasion

Interventions

air abrasionPROCEDURE

already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin

air abrasion versus sono abrasiondental bur versus air abrasion
sono abrasionPROCEDURE

already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin

air abrasion versus sono abrasionsono abrasion versus dental bur
dental burPROCEDURE

already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin

dental bur versus air abrasionsono abrasion versus dental bur

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU

Nice, 06000, France

Location

APHP

Paris, 75000, France

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Air Abrasion, Dental

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2013

First Posted

November 2, 2015

Study Start

June 1, 2008

Primary Completion

December 1, 2013

Study Completion

December 1, 2015

Last Updated

April 25, 2016

Record last verified: 2015-09

Locations