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

NCT ID: NCT00674869

Last Updated: 2012-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2008-12-31

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

Conditions

Caries, Dental

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

pit and fissure sealant

Intervention Type: OTHER

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

2

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

pit and fissure sealant

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michèle Muller-Bolla, Pr

Role: PRINCIPAL_INVESTIGATOR

Service d'Odontologie

Locations

Centre Hospitalier Universitaire de Nice

Nice, , France

Countries

France

Other Identifiers

03-APR-12

Identifier Type: -

Identifier Source: org_study_id