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

Caries, Dental Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674869
• Other study ID #: 03-APR-12
• Status: Completed
• Phase: N/A
• First received: April 22, 2008
• Last updated: February 20, 2012
• Start date: December 2004
• Est. completion date: December 2008

Study information

• Verified date: June 2009
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la SantéFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Caries, Dental
• Dental Caries

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caries development		every six month during 2 years	No
Secondary	CAOD		every six months during 2 years	No
Secondary	Retention sealing of furrows (grooves)		every 6 months during 2 years	No