NCT01038817CompletedPhase 4
Evaluation of the Impact of Fluoride Vanish Application in Dental Prevention Among Institutionalised Elderly People
Assistance Publique - Hôpitaux de Paris1 site in 1 country179 target enrollmentStarted: October 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 179
- Locations
- 1
- Primary Endpoint
- incidence of tooth decay at endpoint. Comparison, between the treated and not treated side of the mandibles
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
fluoride varnish
Active Comparator
Duraphat:
Application of fluoride varnish on one side of the mandibles (left or right, randomly selected)
Intervention: Duraphat (Drug)
Outcomes
Primary Outcomes
incidence of tooth decay at endpoint. Comparison, between the treated and not treated side of the mandibles
Time Frame: 2 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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