GingivitisNCT03970759
Meta-analysis of Stannous Fluoride and the Effects on Gingival Health
An observational study of Gingivitis, run by Procter and Gamble at 1 site in United States.
Trial summary
The aim of this 18 study analysis was to compare the effect of bioavailable stannous fluoride (SnF2) dentifrices when used up to 3 months on gingivitis relative to 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
- Gingivitis
- What is being tested?
- Stannous Fluoride Dentifrice
- How many people
- 2,890 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 with mild-moderate gingivitis.
Subjects were excluded from this study for the following reasons;
- pregnancy,
- rampant caries,
- 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: A Review of Meta-Analyses on Bioavailable Stannous Fluoride Dentifrices: Effects on Gingival Health
The aim of this 18 study analysis was to compare the effect of bioavailable stannous fluoride (SnF2) dentifrices when used up to 3 months on gingivitis relative to a positive or negative control dentifrice.
- Conditions
- Gingivitis
- Being tested
- Stannous Fluoride Dentifrice, Positive control dentifrice, Negative control dentifrice
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stannous Fluoride DentifriceDrug
Experimental stannous fluoride (0.454%) dentifrice
Positive control dentifriceDrug
Positive control dentifrice containing (0.3%) triclosan.
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.
Number of Bleeding Sites
Change from baseline as measured on number of bleeding sites (gingival bleeding index or Loe Silness index).
Measured: Up to 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies 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
- 2,890 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
- NCT03970759
- Sponsor's protocol ID
- 2019SnF2GIAnalysis
- Status last verified
- Jun 2019
- First submitted
- 29 May 2019
- Last updated
- 17 Jun 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Biesbrock A, He T, DiGennaro J, Zou Y, Ramsey D, Garcia-Godoy F. The effects of bioavailable gluconate chelated stannous fluoride dentifrice on gingival bleeding: Meta-analysis of eighteen randomized controlled trials. J Clin Periodontol. 2019 Dec;46(12):1205-1216. doi: 10.1111/jcpe.13203.
PubMed 31562774
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Review of Meta-Analyses on Bioavailable Stannous Fluoride Dentifrices: Effects on Gingival Health
- ClinicalTrials.gov ID
- NCT03970759
- Acronym / sponsor ID
- 2019SnF2GIAnalysis
- Conditions
- Gingivitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,890 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
- 3 Jun 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 18 study analysis was to compare the effect of bioavailable stannous fluoride (SnF2) dentifrices when used up to 3 months on gingivitis relative to 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 with mild-moderate gingivitis.
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 DentifriceExperimental stannous fluoride (0.454%) dentifrice | Drug | Stannous Fluoride Dentifrice |
| Positive control dentifricePositive control dentifrice containing (0.3%) triclosan. | 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
Number of Bleeding Sites
Time frame: Up to 12 Weeks
Change from baseline as measured on number of bleeding sites (gingival bleeding index or Loe Silness index).
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 17 Jun 2019.
- Derived from this study: PubMed 31562774Biesbrock A, He T, DiGennaro J, Zou Y, Ramsey D, Garcia-Godoy F. The effects of bioavailable gluconate chelated stannous fluoride dentifrice on gingival bleeding: Meta-analysis of eighteen randomized controlled trials. J Clin Periodontol. 2019 Dec;46(12):1205-1216. doi: 10.1111/jcpe.13203.
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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 Gingivitis, 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 17 Jun 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?
Number of Bleeding Sites (time frame: Up to 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03970759, which also lists 1 linked publication.
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 17 Jun 2019.