Impact of Fluoride Vanish Application in Dental Preventio... | NCT01038817

Studies
Impact of Fluoride Vanish Application in Dental Prevention for Elderly

NCT01038817

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

May 10, 2016Estimated

Enrollment

179Actual

Phase

Phase 4

Conditions

Tooth Decay

Interventions

Duraphat

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

May 2013Actual

Completion Date

May 2016Actual

First Submitted Date

Dec 22, 2009

First Submission Date that Met QC Criteria

Dec 22, 2009

First Posted Date

Dec 24, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2016

Last Update Posted Date

May 10, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

179Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Duraphat	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)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of tooth decay at endpoint. Comparison, between the treated and not treated side of the mandibles		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philippe Charru	Assistance Public Hôpitaux de Paris	Principal Investigator
Marysette Folliguet	Assistance Public Hôpitaux de Paris	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
APHP, Louis Mourier Hospital		Colombes		92700	France

Condition Browse Module

MeSH Terms

ID	Term
D003731	Dental Caries

Ancestor Terms

ID	Term
D017001	Tooth Demineralization
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C023807	sodium fluoride topical preparation

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided