Dental CariesPhase 4NCT02592278
Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars
A Phase 4 study testing Fluoride Varnish in people with Dental Caries, run by Universidad Iberoamericana.
Trial summary
The aim of this study is to determine the effectiveness of fluoride varnishes in the prevention of dental caries lesions in erupting permanent first molars, in high-risk patients. Read more about this study
- Who is it for?
- Ages 6 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Fluoride Varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Mar 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 6 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Informed Consent from parents.
- Child assent
- High risk of dental caries
- At least one sound first permanent molar (ICDAS=0)
Who cannot join
- Bad behaviour
- Any systemic condition, disability
About this study
The aim of this study is to determine the effectiveness of fluoride varnishes in the prevention of dental caries lesions in erupting permanent first molars, in high-risk patients. Using as reference ICDAS criteria, when the success means that the surface maintain an ICDAS value 0 and failure that has change in ICDAS value 0 to 1.
Sample: The sample comprise 180 patients between 6-7 years old with high-risk of dental caries.
Study design: It proposed an experimental design randomized into 3 groups according to the frequency of topical fluoride application.(Group A: every 6 month; Group B: every 3 month; Group C: positive control).
- Conditions
- Dental Caries
- Being tested
- Fluoride Varnish, Control Group
- Keywords
- Dental Caries, Fluoride Varnish, Preschool child, Prevention
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride VarnishDrug
Also called Duraphat (Colgate)
Application of fluoride varnish every 3 and 6 months.
Control GroupDrug
Also called Colgate Total Toothpaste
Twice a day brush with fluoride toothpaste.
| Study group | Role | What they receive |
|---|---|---|
| Fluoride Varnish each 6 months | Experimental | Fluoride Varnish application every 6 months. Receives: Drug: Fluoride Varnish |
| Fluoride Varnish each 3 months | Experimental | Fluoride Varnish application every 3 months. Receives: Drug: Fluoride Varnish |
| Fluoride tooth paste | Active comparator | Control group. Twice a day brush with fluoride toothpaste. Receives: Drug: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of first permanent molars with caries Lesion (taking into account ICDAS criteria)
We are going to measure changed to decay surfaces in first permanent molars = ICDAS > 0 in a year.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Iberoamericana
- Sponsor type
- University, hospital or other
- Collaborators
- Colgate Palmolive
- Responsible party
- Sponsor
- Investigators
- Ninoska Abreu, Principal investigator, Universidad Iberoamericana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592278
- Sponsor's protocol ID
- 04-2015
- Status last verified
- Nov 2016
- First submitted
- 28 Oct 2015
- Last updated
- 4 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars
- ClinicalTrials.gov ID
- NCT02592278
- Acronym / sponsor ID
- 04-2015
- Conditions
- Dental Caries
- Keywords
- Dental Caries, Fluoride Varnish, Preschool child, Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Universidad IberoamericanaUniversity, hospital or other
- Collaborators
- Colgate Palmolive
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 30 Oct 2015 (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.
The aim of this study is to determine the effectiveness of fluoride varnishes in the prevention of dental caries lesions in erupting permanent first molars, in high-risk patients. Using as reference ICDAS criteria, when the success means that the surface maintain an ICDAS value 0 and failure that has change in ICDAS value 0 to 1.
Sample: The sample comprise 180 patients between 6-7 years old with high-risk of dental caries.
Study design: It proposed an experimental design randomized into 3 groups according to the frequency of topical fluoride application.(Group A: every 6 month; Group B: every 3 month; Group C: positive control).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluoride Varnish each 6 months | Experimental | Drug: Fluoride VarnishFluoride Varnish application every 6 months. |
| Fluoride Varnish each 3 months | Experimental | Drug: Fluoride VarnishFluoride Varnish application every 3 months. |
| Fluoride tooth paste | Active comparator | Drug: Control GroupControl group. Twice a day brush with fluoride toothpaste. |
Who may qualify
- Ages
- 6 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Informed Consent from parents.
- Child assent
- High risk of dental caries
- At least one sound first permanent molar (ICDAS=0)
Key exclusion criteria (2 listed)
- Bad behaviour
- Any systemic condition, disability
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 |
|---|---|---|
| Fluoride VarnishAlso: Duraphat (Colgate)Application of fluoride varnish every 3 and 6 months. | Drug | Fluoride Varnish each 3 months, Fluoride Varnish each 6 months |
| Control GroupAlso: Colgate Total ToothpasteTwice a day brush with fluoride toothpaste. | Drug | Fluoride tooth paste |
Primary outcome
Number of first permanent molars with caries Lesion (taking into account ICDAS criteria)
Time frame: One year
We are going to measure changed to decay surfaces in first permanent molars = ICDAS > 0 in a year.
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 4 Nov 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.
Ninoska Abreu principal investigator
Universidad Iberoamericana
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluoride Varnish in people with Dental Caries, run by Universidad Iberoamericana.
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 2 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 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of first permanent molars with caries Lesion (taking into account ICDAS criteria) (time frame: One year). 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 4 Nov 2016.