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

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ClinicalTrials.gov Identifier: NCT00674869
Recruitment Status : Completed
First Posted : May 8, 2008
Last Update Posted : February 22, 2012
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

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.

Condition or disease Intervention/treatment Phase
Caries, Dental Other: pit and fissure sealant Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectiveness of Pit and Fissure Sealants in the Prevention of Dental Caries
Study Start Date : December 2004
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
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

No Intervention: 2
No intervention



Primary Outcome Measures :
  1. Caries development [ Time Frame: every six month during 2 years ]

Secondary Outcome Measures :
  1. CAOD [ Time Frame: every six months during 2 years ]
  2. Retention sealing of furrows (grooves) [ Time Frame: every 6 months during 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00674869     History of Changes
Other Study ID Numbers: 03-APR-12
First Posted: May 8, 2008    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: June 2009

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