Enamel ErosionPhase 3NCT01641237
Effect of Fluoride in a Dentifrice on Remineralization of Erosive Lesions
A Phase 3 study testing sodium fluoride and no added fluoride in a silica base in people with Enamel Erosion, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The proposed study will evaluate the performance of fluoride delivered from a new dentifrice formulation without potassium nitrate. It will also evaluate the dose-response to fluoride by testing four dentifrices covering a range of sodium fluoride concentration. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Enamel Erosion
- What is being tested?
- sodium fluoride and no added fluoride in a silica base
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to May 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- intact maxillary dental arch suitable to retain a palatal appliance, an intact mandibular dental arch and a stimulated/unstimulated saliva flow rate of ≥ 0.8 milliliter/minute (ml/min) and ≥ 0.2 ml/min respectively.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Dentistry
Indianapolis, Indiana, 46202
About this study
Official title: The Effect of Fluoride in an Experimental Dentifrice on Remineralization of Erosive Lesions In-Situ
The proposed study will evaluate the performance of fluoride delivered from a new dentifrice formulation without potassium nitrate. It will also evaluate the dose-response to fluoride by testing four dentifrices covering a range of sodium fluoride concentration.
- Conditions
- Enamel Erosion
- Being tested
- sodium fluoride, no added fluoride in a silica base
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium fluorideDrug
fluoride as sodium fluoride
no added fluoride in a silica baseDrug
no added fluoride
| Study group | Role | What they receive |
|---|---|---|
| Low ppm fluoride dentifrice | Experimental | Low ppm fluoride as sodium fluoride in a silica base dentifrice Receives: Drug: sodium fluoride |
| Medium ppm fluoride dentifrice | Experimental | Medium ppm fluoride as sodium fluoride in a silica base dentifrice Receives: Drug: sodium fluoride |
| High ppm fluoride dentifrice | Experimental | High ppm fluoride as sodium fluoride in a silica base dentifrice Receives: Drug: sodium fluoride |
| No fluoride dentifrice | Placebo comparator | no added fluoride in a silica base dentifrice Receives: Drug: no added fluoride in a silica base |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship
SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.
Measured: Baseline to 4 hours
Secondary outcomes (3)
%SMHR
SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.
Measured: Baseline to 4 hours
Percentage Relative Erosion Resistance
Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine relative erosion resistance which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent relative erosion resistance was calculated by formula: [(E1-E2)/ (E1-B)]*100.
Measured: Baseline to 4 hours
Enamel Fluoride Uptake (Corrected Data)
Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of fluoride divided by area of the enamel cores. Data analysis was based on corrected data.
Measured: Baseline to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Enamel ErosionStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641237
- Sponsor's protocol ID
- RH01299
- Status last verified
- Jun 2014
- First submitted
- 12 Jul 2012
- Last updated
- 24 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fluoride in an Experimental Dentifrice on Remineralization of Erosive Lesions In-Situ
- ClinicalTrials.gov ID
- NCT01641237
- Acronym / sponsor ID
- RH01299
- Conditions
- Enamel Erosion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 16 Jul 2012 (estimated)
- Results
- Posted 31 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study will evaluate the performance of fluoride delivered from a new dentifrice formulation without potassium nitrate. It will also evaluate the dose-response to fluoride by testing four dentifrices covering a range of sodium fluoride concentration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low ppm fluoride dentifrice | Experimental | Drug: sodium fluorideLow ppm fluoride as sodium fluoride in a silica base dentifrice |
| Medium ppm fluoride dentifrice | Experimental | Drug: sodium fluorideMedium ppm fluoride as sodium fluoride in a silica base dentifrice |
| High ppm fluoride dentifrice | Experimental | Drug: sodium fluorideHigh ppm fluoride as sodium fluoride in a silica base dentifrice |
| No fluoride dentifrice | Placebo comparator | Drug: no added fluoride in a silica baseno added fluoride in a silica base dentifrice |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- intact maxillary dental arch suitable to retain a palatal appliance, an intact mandibular dental arch and a stimulated/unstimulated saliva flow rate of ≥ 0.8 milliliter/minute (ml/min) and ≥ 0.2 ml/min respectively.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| sodium fluoridefluoride as sodium fluoride | Drug | High ppm fluoride dentifrice, Low ppm fluoride dentifrice, Medium ppm fluoride dentifrice |
| no added fluoride in a silica baseno added fluoride | Drug | No fluoride dentifrice |
Primary outcome
Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship
Time frame: Baseline to 4 hours
SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.
3 secondary outcomes
%SMHR
Time frame: Baseline to 4 hours
Percentage Relative Erosion Resistance
Time frame: Baseline to 4 hours
Enamel Fluoride Uptake (Corrected Data)
Time frame: Baseline to 4 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Recruiting
Hydroxyapatite Toothpastes and Enamel Remineralization:
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sodium fluoride and no added fluoride in a silica base in people with Enamel Erosion, run by GlaxoSmithKline at 1 site in United States.
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 1 inclusion and 0 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 24 Jul 2014. 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 United States. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship (time frame: Baseline to 4 hours). 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 24 Jul 2014.