Impact of Fluoride Vanish Application in Dental Prevention for Elderly

Phase 4

Completed

• Conditions: Tooth Decay
• Interventions: Drug: Duraphat

• Registration Number: NCT01038817
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

Detailed Description

Application of fluoride varnish on one side of the mandibles (left or right, randomly selected) in a population of institutionalised elderly people.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-12-22
• Study First Submitted QC: 2009-12-22
• Study First Posted: 2009-12-24
• Primary Completion: 2013-05
• Status Verified: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-09
• Last Update Posted: 2016-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
fluoride varnish	Duraphat	Duraphat: Application of fluoride varnish on one side of the mandibles (left or right, randomly selected)

Primary Outcome Measures

Name	Time	Method
incidence of tooth decay at endpoint. Comparison, between the treated and not treated side of the mandibles	2 years

Trial Locations

Locations (1)

APHP, Louis Mourier Hospital; 🇫🇷 Colombes, France