Enamel ErosionNCT04006470
Meta-analysis of Stannous Fluoride and the Effects on Enamel Erosion
An observational study of Enamel Erosion, run by Procter and Gamble at 1 site in United States.
Trial summary
The aim of this 5 study analysis was to compare the effect of bioavailable stannous fluoride (SnF2) dentifrices to assess enamel erosion protection in-situ using surface profilometry. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Enamel Erosion
- What is being tested?
- Stannous fluoride dentifrice
- How many people
- 172 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2018to 30 Nov 2018
- Phase
- Observational
- 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
Study population: This meta-analysis includes healthy adult male and females.
Who may be able to join
- healthy subjects
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Multiple P&G Investigation Clinical Sites
Cincinnati, Ohio, 45040
About this study
Official title: Bioavailable Stannous Fluoride Dentifrice Meta-Analyses: Effects on Dentine Hypersensitivity and Enamel Erosion
The aim of this 5 study analysis was to compare the effect of bioavailable stannous fluoride (SnF2) dentifrices to assess enamel erosion protection in-situ using surface profilometry.
- Conditions
- Enamel Erosion
- Being tested
- Stannous fluoride dentifrice, Positive control dentifrice, Negative control dentifrice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stannous fluoride dentifriceDrug
Stannous fluoride (0.454%) dentifrice
Positive control dentifriceDrug
Positive control dentifrice containing potassium nitrate or arginine.
Negative control dentifriceDrug
Negative control dentifrice containing either sodium fluoride (0.243%) or sodium monofluorophosphate (0.76%)
| Study group | Role | What they receive |
|---|---|---|
| Stannous Fluoride Dentifrice | Twice daily use Receives: Drug: Stannous fluoride dentifrice | |
| Positive control dentifrice | Twice daily use Receives: Drug: Positive control dentifrice | |
| Negative control dentifrice | Twice daily use Receives: Drug: Negative control dentifrice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Surface profilometry
Enamel samples will be measured via profilometry after 10 days of study use.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start8 Jan 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enamel ErosionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006470
- Sponsor's protocol ID
- 2019SnF2ErosionAnalysis
- Status last verified
- Jul 2019
- First submitted
- 1 Jul 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailable Stannous Fluoride Dentifrice Meta-Analyses: Effects on Dentine Hypersensitivity and Enamel Erosion
- ClinicalTrials.gov ID
- NCT04006470
- Acronym / sponsor ID
- 2019SnF2ErosionAnalysis
- Conditions
- Enamel Erosion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 5 Jul 2019 (actual)
- 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 5 study analysis was to compare the effect of bioavailable stannous fluoride (SnF2) dentifrices to assess enamel erosion protection in-situ using surface profilometry.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stannous Fluoride Dentifrice | – | Drug: Stannous fluoride dentifriceTwice daily use |
| Positive control dentifrice | – | Drug: Positive control dentifriceTwice daily use |
| Negative control dentifrice | – | Drug: Negative control dentifriceTwice daily use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This meta-analysis includes healthy adult male and females.
Key inclusion criteria (1 listed)
- healthy subjects
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 |
|---|---|---|
| Stannous fluoride dentifriceStannous fluoride (0.454%) dentifrice | Drug | Stannous Fluoride Dentifrice |
| Positive control dentifricePositive control dentifrice containing potassium nitrate or arginine. | Drug | Positive control dentifrice |
| Negative control dentifriceNegative control dentifrice containing either sodium fluoride (0.243%) or sodium monofluorophosphate (0.76%) | Drug | Negative control dentifrice |
Primary outcome
Change from Baseline Surface profilometry
Time frame: 10 days
Enamel samples will be measured via profilometry after 10 days of study use.
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 5 Jul 2019.
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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.
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?
An observational study of Enamel Erosion, run by Procter and Gamble 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 5 Jul 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 from Baseline Surface profilometry (time frame: 10 days). 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 5 Jul 2019.