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NCT01038817 Clinical Trial

Impact of Fluoride Vanish Application in Dental Prevention for Elderly

Tooth Decay Clinical Trial

— VERNIS  

Official title:
Evaluation of the Impact of Fluoride Vanish Application in Dental Prevention Among Institutionalised Elderly People

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01038817
Other study ID # P070606
Secondary ID
Status Completed
Phase Phase 4
First received December 22, 2009
Last updated May 9, 2016
Start date October 2009
Est. completion date May 2016

Study information
Verified date May 2016
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 179
Est. completion date May 2016
Est. primary completion date May 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• 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)

Locations
Country Name City State
France APHP, Louis Mourier Hospital Colombes

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of tooth decay at endpoint. Comparison, between the treated and not treated side of the mandibles 2 years No
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