Tooth DecayPhase 4VERNISNCT01038817
Impact of Fluoride Vanish Application in Dental Prevention for Elderly
A Phase 4 study testing Duraphat in people with Tooth Decay, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This study questions the interest of fluoride varnish dental application in preventing tooth decay in a population of institutionalised elderly people. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Decay
- What is being tested?
- Duraphat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to May 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of Fluoride Vanish Application in Dental Prevention Among Institutionalised Elderly People
This study questions the interest of fluoride varnish dental application in preventing tooth decay in a population of institutionalised elderly people.
Read the detailed description
Application of fluoride varnish on one side of the mandibles (left or right, randomly selected) in a population of institutionalised elderly people.
- Conditions
- Tooth Decay
- Being tested
- Duraphat
- Keywords
- tooth-decay, prevention, fluoride-varnish, institutionalised elderly people
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| fluoride varnish | Active comparator | Duraphat:
Application of fluoride varnish on one side of the mandibles (left or right, randomly selected) Receives: Drug: Duraphat |
| control | No intervention | no application on the other side |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of tooth decay at endpoint. Comparison, between the treated and not treated side of the mandibles
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startOct 2009
- Primary completionMay 2013
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DecayStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Charru, Principal investigator, Assistance Public Hôpitaux de ParisMarysette Folliguet, Study chair, Assistance Public Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038817
- Sponsor's protocol ID
- P070606
- Acronym
- VERNIS
- Status last verified
- May 2016
- First submitted
- 22 Dec 2009
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Fluoride Vanish Application in Dental Prevention Among Institutionalised Elderly People
- ClinicalTrials.gov ID
- NCT01038817
- Acronym / sponsor ID
- VERNIS / P070606
- Conditions
- Tooth Decay
- Keywords
- tooth-decay, prevention, fluoride-varnish, institutionalised elderly people
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 24 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fluoride varnish | Active comparator | Drug: DuraphatDuraphat: Application of fluoride varnish on one side of the mandibles (left or right, randomly selected) |
| control | No intervention | –no application on the other side |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuraphatAfter prophylactic cleaning of the mouth and teeth, application of fluoride varnish according to the manufacturer's recommendations (up to 0.75 ml per application) | Drug | fluoride varnish |
Primary outcome
incidence of tooth decay at endpoint. Comparison, between the treated and not treated side of the mandibles
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Charru principal investigator
Assistance Public Hôpitaux de Paris
Marysette Folliguet study chair
Assistance Public Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Duraphat in people with Tooth Decay, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of tooth decay at endpoint. Comparison, between the treated and not treated side of the mandibles (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2016.