GingivitisNCT05916521
A Three Month Bleeding-Model Clinical Study
A study testing 0.454% stannous fluoride, 0.76% sodium monofluorophosphate and 0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM in people with Gingivitis, run by Procter and Gamble at 1 site in United States.
Trial summary
The objective of the study is to evaluate the gingivitis control benefit of an established stannous fluoride containing toothpaste relative to a 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?
- 0.454% stannous fluoride, 0.76% sodium monofluorophosphate and 0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to 11 Feb 2022
- Phase
- Interventional
- 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
Who may be able to join
- Be at least 18 years of age;
- Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
- Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
- Have at least 20 gradable teeth;
- Have established gingivitis with 10-70% bleeding sites;
- Agree to return for scheduled visits and follow the study procedures;
- Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
- Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study.
Who cannot join
- Having taken medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the Baseline Visit;
- Having any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
- Having known hypersensitivity to the test products;
- Having removable oral appliances;
- Having fixed facial or lingual orthodontic appliances;
- Self-reported pregnancy or lactation;
- Having any diseases or condition that might interfere with the safe participation in the study;
- Having an inability to undergo study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Three-Month Bleeding-Model Clinical Study
The objective of the study is to evaluate the gingivitis control benefit of an established stannous fluoride containing toothpaste relative to a negative control dentifrice.
- Conditions
- Gingivitis
- Being tested
- 0.454% stannous fluoride, 0.76% sodium monofluorophosphate, 0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.454% stannous fluorideDrug
Brush two times daily
0.76% sodium monofluorophosphateDrug
Brush two times daily
0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PMDrug
Brush two times daily
| Study group | Role | What they receive |
|---|---|---|
| Positive Control | Active comparator | 2 brushings per day (AM and PM) Receives: Drug: 0.454% stannous fluoride |
| Negative Control | Sham comparator | 2 brushings per day (AM and PM) Receives: Drug: 0.76% sodium monofluorophosphate |
| Experimental Control | Experimental | Brush with Positive control in the morning and negative control in the evening Receives: Drug: 0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Löe-Silness Gingivitis Evaluation
Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).
Measured: Baseline
Löe-Silness Gingivitis Evaluation
Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).
Measured: Week 4
Löe-Silness Gingivitis Evaluation
Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start15 Nov 2021
- Primary completion11 Feb 2022
- Study completion11 Feb 2022
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 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
- NCT05916521
- Sponsor's protocol ID
- 2021086
- Status last verified
- Jun 2023
- First submitted
- 14 Jun 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
He T, Zou Y, Grender J, Amini P, Kaminski M, Biesbrock AR. Randomized Controlled Trials Assessing Exposure Frequency Effects of Stannous Fluoride on Gingivitis. JDR Clin Trans Res. 2025 Apr;10(2):124-134. doi: 10.1177/23800844241263031. Epub 2024 Aug 8.
PubMed 39118360
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-Month Bleeding-Model Clinical Study
- ClinicalTrials.gov ID
- NCT05916521
- Acronym / sponsor ID
- 2021086
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 11 Feb 2022 (actual)
- Study completion
- 11 Feb 2022 (actual)
- First posted
- 23 Jun 2023 (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 objective of the study is to evaluate the gingivitis control benefit of an established stannous fluoride containing toothpaste relative to a negative control dentifrice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Positive Control | Active comparator | Drug: 0.454% stannous fluoride2 brushings per day (AM and PM) |
| Negative Control | Sham comparator | Drug: 0.76% sodium monofluorophosphate2 brushings per day (AM and PM) |
| Experimental Control | Experimental | Drug: 0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PMBrush with Positive control in the morning and negative control in the evening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be at least 18 years of age;
- Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
- Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
- Have at least 20 gradable teeth;
- Have established gingivitis with 10-70% bleeding sites;
Key exclusion criteria (8 listed)
- Having taken medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the Baseline Visit;
- Having any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
- Having known hypersensitivity to the test products;
- Having removable oral appliances;
- Having fixed facial or lingual 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 |
|---|---|---|
| 0.454% stannous fluorideBrush two times daily | Drug | Positive Control |
| 0.76% sodium monofluorophosphateBrush two times daily | Drug | Negative Control |
| 0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PMBrush two times daily | Drug | Experimental Control |
Primary outcome
Löe-Silness Gingivitis Evaluation
Time frame: Baseline
Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).
Löe-Silness Gingivitis Evaluation
Time frame: Week 4
Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).
Löe-Silness Gingivitis Evaluation
Time frame: Week 12
Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).
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 23 Jun 2023.
- Derived from this study: PubMed 39118360He T, Zou Y, Grender J, Amini P, Kaminski M, Biesbrock AR. Randomized Controlled Trials Assessing Exposure Frequency Effects of Stannous Fluoride on Gingivitis. JDR Clin Trans Res. 2025 Apr;10(2):124-134. doi: 10.1177/23800844241263031. Epub 2024 Aug 8.
Related trials for Gingivitis
Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
Gingivitis
Not yet recruitingObservational study
Salivary and GCF Biomarkers in Periodontal Health, Gingivitis and Periodontitis
Periodontal Health, Gingivitis
Not yet recruiting
Individualized Management of Plaque-Related Gingival Inflammation in Routine Dental Practice
Plaque-Induced Gingivitis
Recruiting
The Study to Evaluate the Plaque Control and Anti-Gingivitis Efficacy of a Toothpaste in Chinese Population
Dental Plaque, Gingivitis
Recruiting
Alpha-Lipoic Acid as an Adjunct to Non-Surgical Periodontal Treatment in Gingivitis
Gingivitis and Periodontal Diseases
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 study testing 0.454% stannous fluoride, 0.76% sodium monofluorophosphate and 0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM in people with 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?
The sponsor lists 8 inclusion and 8 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 23 Jun 2023. 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.
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?
Löe-Silness Gingivitis Evaluation (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT05916521, 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 23 Jun 2023.