Impact of Fluoride Vanish Application in Dental Prevention for Elderly (VERNIS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01038817
First received: December 22, 2009
Last updated: July 25, 2012
Last verified: July 2009
  Purpose

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


Condition Intervention Phase
Tooth Decay
Drug: Duraphat
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Evaluation of the Impact of Fluoride Vanish Application in Dental Prevention Among Institutionalised Elderly People

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • incidence of tooth decay at endpoint. Comparison, between the treated and not treated side of the mandibles [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2009
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: fluoride varnish

Duraphat:

Application of fluoride varnish on one side of the mandibles (left or right, randomly selected)

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)
Other Name: Duraphat
No Intervention: control
no application on the other side

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038817

Contacts
Contact: Philippe Charru 01 47 60 66 80 philippe.charru@lmr.aphp.fr
Contact: Folliguet Marysette 01 47 60 68 40 marysette.folliguet@lmr.aphp.fr

Locations
France
APHP, Louis Mourier Hospital Recruiting
Colombes, France, 92700
Contact: Philippe Charru    01 47 60 66 80    philippe.charru@lmr.aphp.fr   
Sub-Investigator: Agnès Veille Finet         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Philippe Charru Assistance Public Hôpitaux de Paris
Study Chair: Marysette Folliguet Assistance Public Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01038817     History of Changes
Other Study ID Numbers: P070606
Study First Received: December 22, 2009
Last Updated: July 25, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
tooth-decay
prevention
fluoride-varnish
institutionalised elderly people

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides, Topical
Fluorides
Sodium Fluoride
Sodium fluoride topical preparation
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 20, 2014