Impact of Fluoride Vanish Application in Dental Prevention for Elderly

NCT ID: NCT01038817

Last Updated: 2016-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2016-05-31

Brief Summary

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

Detailed Description

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

Conditions

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Tooth Decay

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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fluoride varnish

Duraphat:

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

Group Type ACTIVE_COMPARATOR

Duraphat

Intervention Type DRUG

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)

control

no application on the other side

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe Charru

Role: PRINCIPAL_INVESTIGATOR

Assistance Public Hôpitaux de Paris

Marysette Folliguet

Role: STUDY_CHAIR

Assistance Public Hôpitaux de Paris

Locations

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APHP, Louis Mourier Hospital

Colombes, , France

Site Status

Countries

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France

Other Identifiers

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P070606

Identifier Type: -

Identifier Source: org_study_id

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