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

Primary Purpose

Tooth Decay

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Duraphat
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tooth Decay focused on measuring tooth-decay, prevention, fluoride-varnish, institutionalised elderly people

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • APHP, Louis Mourier Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

fluoride varnish

control

Arm Description

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

no application on the other side

Outcomes

Primary Outcome Measures

incidence of tooth decay at endpoint. Comparison, between the treated and not treated side of the mandibles

Secondary Outcome Measures

Full Information

First Posted
December 22, 2009
Last Updated
May 9, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01038817
Brief Title
Impact of Fluoride Vanish Application in Dental Prevention for Elderly
Acronym
VERNIS
Official Title
Evaluation of the Impact of Fluoride Vanish Application in Dental Prevention Among Institutionalised Elderly People
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Decay
Keywords
tooth-decay, prevention, fluoride-varnish, institutionalised elderly people

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
179 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fluoride varnish
Arm Type
Active Comparator
Arm Description
Duraphat: Application of fluoride varnish on one side of the mandibles (left or right, randomly selected)
Arm Title
control
Arm Type
No Intervention
Arm Description
no application on the other side
Intervention Type
Drug
Intervention Name(s)
Duraphat
Intervention Description
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)
Primary Outcome Measure Information:
Title
incidence of tooth decay at endpoint. Comparison, between the treated and not treated side of the mandibles
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Charru
Organizational Affiliation
Assistance Public Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marysette Folliguet
Organizational Affiliation
Assistance Public Hôpitaux de Paris
Official's Role
Study Chair
Facility Information:
Facility Name
APHP, Louis Mourier Hospital
City
Colombes
ZIP/Postal Code
92700
Country
France

12. IPD Sharing Statement

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Impact of Fluoride Vanish Application in Dental Prevention for Elderly

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