NCT01038817

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 24, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 10, 2016

Status Verified

May 1, 2016

Enrollment Period

3.6 years

First QC Date

December 22, 2009

Last Update Submit

May 9, 2016

Conditions

Tooth Decay

Keywords

tooth-decaypreventionfluoride-varnishinstitutionalised elderly people

Outcome Measures

Primary Outcomes (1)

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

    2 years

Study Arms (2)

fluoride varnish

ACTIVE COMPARATOR

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

Drug: Duraphat

control

NO INTERVENTION

no application on the other side

Interventions

DuraphatDRUG

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)

fluoride varnish

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient hospitalised in nursing home or long-stay hospital department
  • patient older than 18 years old
  • obtention of informed consent
  • or more healthy or treated teeth on each side (left and right) of the mandibles

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APHP, Louis Mourier Hospital

Colombes, 92700, France

Location

MeSH Terms

Conditions

Dental Caries

Interventions

sodium fluoride topical preparation

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Philippe Charru

    Assistance Public Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • Marysette Folliguet

    Assistance Public Hôpitaux de Paris

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2009

First Posted

December 24, 2009

Study Start

October 1, 2009

Primary Completion

May 1, 2013

Study Completion

May 1, 2016

Last Updated

May 10, 2016

Record last verified: 2016-05

Locations

FR(1)