NCT00674869

Brief Summary

This randomized clinical trial is aimed at testing the efficacy of pit and fissure sealants, in a current environmental context different from that of the seventies and eighties. It has a split mouth design. 4OO subjects are included and the duration of follow up is 2 years.

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 Dec 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2008

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 8, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

February 22, 2012

Status Verified

June 1, 2009

Enrollment Period

4 years

First QC Date

April 22, 2008

Last Update Submit

February 20, 2012

Conditions

Caries, Dental

Keywords

sealantpitchildover6 years oldleast

Outcome Measures

Primary Outcomes (1)

  • Caries development

    every six month during 2 years

Secondary Outcomes (2)

  • CAOD

    every six months during 2 years

  • Retention sealing of furrows (grooves)

    every 6 months during 2 years

Study Arms (2)

1

EXPERIMENTAL

pit and fissure sealant on one randomized tooth by pair of permanent molar

Other: pit and fissure sealant

2

NO INTERVENTION

No intervention

Interventions

pit and fissure sealantOTHER

pit and fissure sealant on one randomized tooth by pair of permanent molar

1

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • child over 6 years old
  • patient with at least one carie
  • patient with at least one pair of permanent molar: healthy or with equivalent injuries

You may not qualify if:

  • not cooperating in care
  • not speaking french or english

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Nice

Nice, 06000, France

Location

MeSH Terms

Conditions

Dental CariesVan der Woude syndrome

Interventions

Pit and Fissure Sealants

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Michèle Muller-Bolla, Pr

    Service d'Odontologie

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 22, 2008

First Posted

May 8, 2008

Study Start

December 1, 2004

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

February 22, 2012

Record last verified: 2009-06

Locations

FR(1)