This trial is active, not recruiting.

Condition tooth decay
Treatment duraphat
Phase phase 4
Sponsor Assistance Publique - Hôpitaux de Paris
Start date October 2009
End date May 2013
Trial size 300 participants
Trial identifier NCT01038817, P070606


This study questions the interest of fluoride varnish dental application in preventing tooth decay in a population of institutionalised elderly people.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double blind (subject, investigator)
Primary purpose prevention
(Active Comparator)
Duraphat: Application of fluoride varnish on one side of the mandibles (left or right, randomly selected)
duraphat Duraphat
After prophylactic cleaning of the mouth and teeth, application of fluoride varnish according to the manufacturer's recommendations (up to 0.75 ml per application)
(No Intervention)
no application on the other side

Primary Outcomes

incidence of tooth decay at endpoint. Comparison, between the treated and not treated side of the mandibles
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - patient hospitalised in nursing home or long-stay hospital department - patient older than 18 years old - obtention of informed consent - 3 or more healthy or treated teeth on each side (left and right) of the mandibles Exclusion Criteria: - patient in palliative care or end-of-life care - patient without social security affiliation - patient participating in another research dealing with dental care - contra-indication to fluoride varnish

Additional Information

Official title Evaluation of the Impact of Fluoride Vanish Application in Dental Prevention Among Institutionalised Elderly People
Principal investigator Philippe Charru
Description Application of fluoride varnish on one side of the mandibles (left or right, randomly selected) in a population of institutionalised elderly people.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.