Dentine HypersensitivityNCT04005417
Meta-analysis of Stannous Fluoride Dentifrice and the Effects on Dentine Hypersensitivity
An observational study of Dentine Hypersensitivity, run by Procter and Gamble at 1 site in United States.
Trial summary
The aim of this 11 study analysis was to compare the effect of bioavailable stannous fluoride (SnF2) on dentine hypersensitivity versus a positive or negative control dentifrice. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dentine Hypersensitivity
- What is being tested?
- Stannous fluoride dentifrice
- How many people
- 1,036 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.
Subjects were excluded from this study for the following reasons;
- severe periodontitis
- at discretionary of the Principal Investigator
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 11 study analysis was to compare the effect of bioavailable stannous fluoride (SnF2) on dentine hypersensitivity versus a positive or negative control dentifrice.
- Conditions
- Dentine Hypersensitivity
- Being tested
- Stannous fluoride dentifrice, Positive control dentifrice, Negative control dentifrice
- Medical subject headings
- Dentin Sensitivity
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 brushing Receives: Drug: Stannous fluoride dentifrice | |
| Positive control dentifrice | Twice daily brushing Receives: Drug: Positive control dentifrice | |
| Negative control dentifrice | Twice daily brushing 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 Air Challenge
The Schiff Sensitivity Scale is assessed for each test tooth via an evaporative air challenge. The examiner records the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth.
Measured: Up to 8 weeks
Change from Baseline in Tactile Threshold
Tactile Threshold is measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and is recorded as the threshold on the Tactile Sensitivity Score form.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 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 Dentine HypersensitivityStudies 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
- 1,036 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
- NCT04005417
- Sponsor's protocol ID
- 2019SnF2SensitivityAnalysis
- Status last verified
- Jul 2019
- First submitted
- 1 Jul 2019
- Last updated
- 2 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 2 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
- NCT04005417
- Acronym / sponsor ID
- 2019SnF2SensitivityAnalysis
- Conditions
- Dentine Hypersensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,036 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
- 2 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 11 study analysis was to compare the effect of bioavailable stannous fluoride (SnF2) on dentine hypersensitivity versus a positive or negative control dentifrice.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stannous fluoride dentifrice | – | Drug: Stannous fluoride dentifriceTwice daily brushing |
| Positive control dentifrice | – | Drug: Positive control dentifriceTwice daily brushing |
| Negative control dentifrice | – | Drug: Negative control dentifriceTwice daily brushing |
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.
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 Air Challenge
Time frame: Up to 8 weeks
The Schiff Sensitivity Scale is assessed for each test tooth via an evaporative air challenge. The examiner records the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth.
Change from Baseline in Tactile Threshold
Time frame: Up to 8 weeks
Tactile Threshold is measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and is recorded as the threshold on the Tactile Sensitivity Score form.
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 2 Jul 2019.
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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 Dentine Hypersensitivity, 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?
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 2 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 Air Challenge (time frame: Up to 8 weeks). 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 2 Jul 2019.