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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00674869
First received: April 22, 2008
Last updated: February 20, 2012
Last verified: June 2009
  Purpose

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.


Condition Intervention
Caries, Dental
Other: pit and fissure sealant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effectiveness of Pit and Fissure Sealants in the Prevention of Dental Caries

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • Caries development [ Time Frame: every six month during 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CAOD [ Time Frame: every six months during 2 years ] [ Designated as safety issue: No ]
  • Retention sealing of furrows (grooves) [ Time Frame: every 6 months during 2 years ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: December 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
pit and fissure sealant on one randomized tooth by pair of permanent molar
Other: pit and fissure sealant
pit and fissure sealant on one randomized tooth by pair of permanent molar
Other Name: pit and fissure sealant
No Intervention: 2
No intervention

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

  Eligibility

Ages Eligible for Study:   6 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674869

Locations
France
Centre Hospitalier Universitaire de Nice
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Michèle Muller-Bolla, Pr Service d'Odontologie
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00674869     History of Changes
Other Study ID Numbers: 03-APR-12
Study First Received: April 22, 2008
Last Updated: February 20, 2012
Health Authority: France: Direction Générale de la Santé
France: Institutional Ethical Committee

Keywords provided by Centre Hospitalier Universitaire de Nice:
sealant
pit
child
over
6 years old
least

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on August 28, 2014