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Effectiveness of Pit and Fissure Sealants in the Prevention of Dental Caries

Primary Purpose

Caries, Dental

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
pit and fissure sealant
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Caries, Dental focused on measuring sealant, pit, child, over, 6 years old, least

Eligibility Criteria

6 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • not cooperating in care
  • not speaking french or english

Sites / Locations

  • Centre Hospitalier Universitaire de Nice

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

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

No intervention

Outcomes

Primary Outcome Measures

Caries development

Secondary Outcome Measures

CAOD
Retention sealing of furrows (grooves)

Full Information

First Posted
April 22, 2008
Last Updated
February 20, 2012
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT00674869
Brief Title
Effectiveness of Pit and Fissure Sealants in the Prevention of Dental Caries
Official Title
Effectiveness of Pit and Fissure Sealants in the Prevention of Dental Caries
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (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 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.
Detailed Description
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. This study assesses the cost-effectiveness of sealants according to the individual caries risk. This study takes place in Nice, Marseille and Paris (France) and the patients are to be enrolled both in the dental hospitals and in the private practice. In the hospitals, the subjects are recruited directly by the headmasters of the pediatric dentistry or public health departments in the three dental schools. In private practice, the head of the department of pediatric dentistry and / or public health dentistry, of each dental school chooses 4 to 6 private practitioners who are used to place dental sealants in their daily practice. They recruit the subjects among their own patients. The type of study corresponds to randomized clinical trial (Split mouth design) in which the tooth is the statistical unit (one pair of molars considered for each included patient). This study has a direct benefit for individuals. The number of necessary subjects is 328; the sample size is 400. The follow-up duration is 2 years. The treatment is a pit and fissure sealant on one randomized tooth by pair of permanent molars (Split mouth design). Sealant material is set up in accordance with the usual practice of each practitioner. Occlusal exams are conducted every 6 months. The effectiveness of dental sealants and the retention of sealing materials are statistically analyzed according to both the individual caries risk and the clinical protocol

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries, Dental
Keywords
sealant, pit, child, over, 6 years old, least

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
pit and fissure sealant on one randomized tooth by pair of permanent molar
Arm Title
2
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
pit and fissure sealant
Intervention Description
pit and fissure sealant on one randomized tooth by pair of permanent molar
Primary Outcome Measure Information:
Title
Caries development
Time Frame
every six month during 2 years
Secondary Outcome Measure Information:
Title
CAOD
Time Frame
every six months during 2 years
Title
Retention sealing of furrows (grooves)
Time Frame
every 6 months during 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: not cooperating in care not speaking french or english
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michèle Muller-Bolla, Pr
Organizational Affiliation
Service d'Odontologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Nice
City
Nice
ZIP/Postal Code
06000
Country
France

12. IPD Sharing Statement

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Effectiveness of Pit and Fissure Sealants in the Prevention of Dental Caries

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