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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01038817
First received: December 22, 2009
Last updated: May 9, 2016
Last verified: May 2016
  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 ]

Enrollment: 179
Study Start Date: October 2009
Study Completion Date: May 2016
Primary Completion Date: May 2013 (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)
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
APHP, Louis Mourier Hospital
Colombes, France, 92700
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

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: May 9, 2016
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
Fluorides, Topical
Sodium fluoride topical preparation
Sodium Fluoride
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 21, 2016