Dental CariesEarly Phase 1NCT02486458
Long-term Release of Fluoride Formed on Enamel by Fluoride Gel or Varnish to Biofilm Fluid
A Early Phase 1 study testing 5% sodium fluoride varnish and 1.23% sodium fluoride acidic gel in people with Dental Caries, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
The anticaries effect of professional fluoride application has been associated with the formation of calcium fluoride-like products ("CaF2") on dental surface, which may function as a slow release fluoride reservoir. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- 5% sodium fluoride varnish and 1.23% sodium fluoride acidic gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2015to Dec 2016
- Phase
- Early Phase 1
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good general health
- Good oral health
- At least 5 teeth in each hemiarch
- All 4 superior incisors in the mouth
- Rapid biofilm forming
Who cannot join
- Pregnancy
- Intake of medication that reduces salivary flow
- Chronic diseases
- Smokers
- Orthodontic appliances
- Dental prosthesis
- Allergy to fluoride varnish components
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retention of Fluoride Formed on Enamel by Fluoride Gel or Varnish Application and Its Release to Dental Biofilm Fluid - in Vivo Study
The anticaries effect of professional fluoride application has been associated with the formation of calcium fluoride-like products ("CaF2") on dental surface, which may function as a slow release fluoride reservoir. Among professional fluoride products, fluoride gel and varnish are the most important, and have different soluble fluoride concentrations, pHs and vehicles. Although the concentration of fluoride formed on enamel after the use of both is similar, the retention of these reaction products is unknown. Also, it is unknown the capacity of these reservoirs to enhance dental biofilm fluid with fluoride. Moreover, the effect of the varnish application time on these parameters is unknown. Therefore, the aim of this study is to compare the capacity of fluoride gel and varnish to form fluoride reservoirs on enamel and increase dental biofilm fluid fluoride concentration with time. Rapid biofilm-forming individuals will be selected to participate and divided into 4 experimental groups: 1. Negative control: no treatment; 2. Varnish 4 hours: fluoride varnish will be applied and kept on teeth for 4 hours; 3. Varnish 24 h: fluoride varnish will be applied on teeth and kept for 24 h; and 4. Gel: Fluoride gel will be applied on teeth. Microbiopsies of enamel will be obtained by a microbiospy technique to assess fluoride concentration before, 7 and 28 days after the treatments. Dental biofilm will be collected before and 3, 7, 14 and 28 days after treatments. Fluoride concentration on enamel and in the biofilm fluid will be determined by an ion-specific electrode. Data will be analyzed statistically comparing the groups and collection times.
- Conditions
- Dental Caries
- Being tested
- 5% sodium fluoride varnish, 1.23% sodium fluoride acidic gel
- Keywords
- Fluoride, Biofilm fluid, Calcium fluoride, Topical
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% sodium fluoride varnishDrug
Fluoride varnish containing 22,600 ppm F, as NaF, in a neutral base
1.23% sodium fluoride acidic gelDrug
Fluoride gel containing 12,300 ppm F (as NaF) in an acidic pH (by addition of phosphoric acid)
| Study group | Role | What they receive |
|---|---|---|
| Negative control | No intervention | No treatment will be applied |
| Varnish 4 h | Experimental | Fluoride varnish will be applied on teeth and removed after 4 hours Receives: Drug: 5% sodium fluoride varnish |
| Varnish 24 h | Experimental | Fluoride varnish will be applied on teeth and removed after 24 hours Receives: Drug: 5% sodium fluoride varnish |
| Fluoride Gel | Experimental | Fluoride gell will be applied on teeth and removed after 4 minutes Receives: Drug: 1.23% sodium fluoride acidic gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fluoride concentration in enamel days after fluoride application
Measured: Up to 28 days
Change in fluoride concentration in dental biofilm fluid days after fluoride application
Measured: Up to 28 days
Secondary outcomes (1)
Change in fluoride concentration in whole biofilm days after fluoride application
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2015
- Study completionDec 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Livia Maria Andaló Tenuta, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486458
- Sponsor's protocol ID
- FOPBioq005
- Status last verified
- May 2017
- First submitted
- 26 May 2015
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retention of Fluoride Formed on Enamel by Fluoride Gel or Varnish Application and Its Release to Dental Biofilm Fluid - in Vivo Study
- ClinicalTrials.gov ID
- NCT02486458
- Acronym / sponsor ID
- FOPBioq005
- Conditions
- Dental Caries
- Keywords
- Fluoride, Biofilm fluid, Calcium fluoride, Topical
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 1 Jul 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 anticaries effect of professional fluoride application has been associated with the formation of calcium fluoride-like products ("CaF2") on dental surface, which may function as a slow release fluoride reservoir. Among professional fluoride products, fluoride gel and varnish are the most important, and have different soluble fluoride concentrations, pHs and vehicles. Although the concentration of fluoride formed on enamel after the use of both is similar, the retention of these reaction products is unknown. Also, it is unknown the capacity of these reservoirs to enhance dental biofilm fluid with fluoride. Moreover, the effect of the varnish application time on these parameters is unknown. Therefore, the aim of this study is to compare the capacity of fluoride gel and varnish to form fluoride reservoirs on enamel and increase dental biofilm fluid fluoride concentration with time. Rapid biofilm-forming individuals will be selected to participate and divided into 4 experimental groups: 1. Negative control: no treatment; 2. Varnish 4 hours: fluoride varnish will be applied and kept on teeth for 4 hours; 3. Varnish 24 h: fluoride varnish will be applied on teeth and kept for 24 h; and 4. Gel: Fluoride gel will be applied on teeth. Microbiopsies of enamel will be obtained by a microbiospy technique to assess fluoride concentration before, 7 and 28 days after the treatments. Dental biofilm will be collected before and 3, 7, 14 and 28 days after treatments. Fluoride concentration on enamel and in the biofilm fluid will be determined by an ion-specific electrode. Data will be analyzed statistically comparing the groups and collection times.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Negative control | No intervention | –No treatment will be applied |
| Varnish 4 h | Experimental | Drug: 5% sodium fluoride varnishFluoride varnish will be applied on teeth and removed after 4 hours |
| Varnish 24 h | Experimental | Drug: 5% sodium fluoride varnishFluoride varnish will be applied on teeth and removed after 24 hours |
| Fluoride Gel | Experimental | Drug: 1.23% sodium fluoride acidic gelFluoride gell will be applied on teeth and removed after 4 minutes |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Good general health
- Good oral health
- At least 5 teeth in each hemiarch
- All 4 superior incisors in the mouth
- Rapid biofilm forming
Key exclusion criteria (7 listed)
- Pregnancy
- Intake of medication that reduces salivary flow
- Chronic diseases
- Smokers
- Orthodontic appliances
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 |
|---|---|---|
| 5% sodium fluoride varnishFluoride varnish containing 22,600 ppm F, as NaF, in a neutral base | Drug | Varnish 24 h, Varnish 4 h |
| 1.23% sodium fluoride acidic gelFluoride gel containing 12,300 ppm F (as NaF) in an acidic pH (by addition of phosphoric acid) | Drug | Fluoride Gel |
Primary outcome
Change in fluoride concentration in enamel days after fluoride application
Time frame: Up to 28 days
Change in fluoride concentration in dental biofilm fluid days after fluoride application
Time frame: Up to 28 days
1 secondary outcome
Change in fluoride concentration in whole biofilm days after fluoride application
Time frame: Up to 28 days
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 9 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 5% sodium fluoride varnish and 1.23% sodium fluoride acidic gel in people with Dental Caries, run by University of Campinas, Brazil at 1 site in Brazil.
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 5 inclusion and 7 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 9 May 2017. 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 Brazil. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change in fluoride concentration in enamel days after fluoride application (time frame: Up to 28 days). The study lists 2 primary outcomes in all. 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 9 May 2017.