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
Recruitment status was Recruiting
Sponsor:
Assistance Publique - Hôpitaux de Paris
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
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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 Cariostatic Agents Protective Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013