GingivitisPhase 4NCT07158112
Assessing Gingivitis and Plaque From a Marketed Toothpaste
A Phase 4 study testing Stannous Fluoride Dentifrice, Test Stannous Fluoride Dentifrice and Sodium monofluorophosphate dentifrice in people with Gingivitis, run by Procter and Gamble at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the effect of two 0.454% stannous fluoride dentifrices on gingivitis relative to a negative control (Colgate® Cavity Protection toothpaste) and the comparative anti-gingivitis efficacy of the two 0.454% SnF2 dentifrices after 12 weeks of product use. 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, Test Stannous Fluoride Dentifrice and Sodium monofluorophosphate dentifrice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2025to 7 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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; ii. Provide consent prior to study participation and receive a signed copy of the Informed Consent form; iii. Be in good general health as determined by the Investigator/Designee based on a review of their medical history; iv. Have at least 16 gradable teeth; v. Have mild to moderate gingivitis with 10%-70% bleeding sites; vi. Agree to return for scheduled visits and follow the study procedures; vii. Agree to refrain from use of any non-study oral hygiene products for the duration of the study; viii. Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study; ix. Agree to refrain from any oral hygiene for 12 hours prior to their next visit; x. Agree to refrain from eating, drinking using tobacco in any form (including smoking substances such as marijuana, vaping products, e-cigarettes), flossing, using toothpicks, using medicated lozenges and/or breath mints, or chewing gum at least 4 hours from your next study visit (exception allowed: small sips of water up until 45 minutes prior to their appointment); and, xi. Agree not to participate in any other oral care studies for the duration of this 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; ii. Have 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; iii. Have any of the following: fixed orthodontic appliances or attachments for aligner treatment, lower bonded retainers; removable partial dentures, iv. Have a history of allergies or hypersensitivity to ingredients in commercial dental products or cosmetics; v. Had oral/gum surgery within the previous two months; vi. Nursing, self-reported pregnancy or the intention of becoming pregnant any time during the course of this study; vii. A condition requiring the need for antibiotic premedication prior to dental procedures or use within 2 weeks of the Baseline visit; or viii. Have any condition or disease, as determined by the Investigator/Designee based on a review of the medical history which could be expected to interfere with examination procedures or with the subject's safe completion of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Health Resources Group
Whitter, California, 90602
About this study
Official title: A Randomized Three-Month Clinical Trial Evaluating Anti-Gingivitis Efficacy of Stannous Fluoride Dentifrices Relative to a Negative Control
The primary objective of this study is to evaluate the effect of two 0.454% stannous fluoride dentifrices on gingivitis relative to a negative control (Colgate® Cavity Protection toothpaste) and the comparative anti-gingivitis efficacy of the two 0.454% SnF2 dentifrices after 12 weeks of product use.
- Conditions
- Gingivitis
- Being tested
- Stannous Fluoride Dentifrice, Test Stannous Fluoride Dentifrice, Sodium monofluorophosphate 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
Each subject will be randomly assigned to one of three treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months.
Test Stannous Fluoride DentifriceDrug
Each subject will be randomly assigned to one of three treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months.
Sodium monofluorophosphate dentifriceDrug
Each subject will be randomly assigned to one of three treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Positive Control | Active comparator | 0.454% stannous fluoride Receives: Drug: Stannous Fluoride Dentifrice |
| Negative Control | Active comparator | 0.76% Sodium Monofluorophosphate Receives: Drug: Sodium monofluorophosphate dentifrice |
| Test Product | Active comparator | 0.454% stannous fluoride Receives: Drug: Test Stannous Fluoride Dentifrice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Bleeding Sites
Number of Bleeding Sites
Measured: 1 month and 3 months
Secondary outcomes (2)
Loe-Silness Gingival Evaluation
Evaluation of bleeding and gum inflammation
Measured: 1 month and 3 months
Turesky Plaque Evaluation
Evaluation of Plaque
Measured: 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start30 Aug 2025
- Primary completion7 Dec 2025 (estimated)
- Study completion7 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nachnani, Principal investigator, University Health Resources Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158112
- Sponsor's protocol ID
- 2025029
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Three-Month Clinical Trial Evaluating Anti-Gingivitis Efficacy of Stannous Fluoride Dentifrices Relative to a Negative Control
- ClinicalTrials.gov ID
- NCT07158112
- Acronym / sponsor ID
- 2025029
- Conditions
- Gingivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- 7 Dec 2025 (estimated)
- Study completion
- 7 Dec 2025 (estimated)
- First posted
- 5 Sep 2025 (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 primary objective of this study is to evaluate the effect of two 0.454% stannous fluoride dentifrices on gingivitis relative to a negative control (Colgate® Cavity Protection toothpaste) and the comparative anti-gingivitis efficacy of the two 0.454% SnF2 dentifrices after 12 weeks of product use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Positive Control | Active comparator | Drug: Stannous Fluoride Dentifrice0.454% stannous fluoride |
| Negative Control | Active comparator | Drug: Sodium monofluorophosphate dentifrice0.76% Sodium Monofluorophosphate |
| Test Product | Active comparator | Drug: Test Stannous Fluoride Dentifrice0.454% stannous fluoride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Be at least 18 years of age; ii. Provide consent prior to study participation and receive a signed copy of the Informed Consent form; iii. Be in good general health as determined by the Investigator/Designee based on a review of their medical history; iv. Have at least 16 gradable teeth; v. Have mild to moderate gingivitis with 10%-70% bleeding sites; vi. Agree to return for scheduled visits and follow the study procedures; vii. Agree to refrain from use of any non-study oral hygiene products for the duration of the study; viii. Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study; ix. Agree to refrain from any oral hygiene for 12 hours prior to their next visit; x. Agree to refrain from eating, drinking using tobacco in any form (including smoking substances such as marijuana, vaping products, e-cigarettes), flossing, using toothpicks, using medicated lozenges and/or breath mints, or chewing gum at least 4 hours from your next study visit (exception allowed: small sips of water up until 45 minutes prior to their appointment); and, xi. Agree not to participate in any other oral care studies for the duration of this study.
Key exclusion criteria (1 listed)
- Having taken medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the Baseline Visit; ii. Have 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; iii. Have any of the following: fixed orthodontic appliances or attachments for aligner treatment, lower bonded retainers; removable partial dentures, iv. Have a history of allergies or hypersensitivity to ingredients in commercial dental products or cosmetics; v. Had oral/gum surgery within the previous two months; vi. Nursing, self-reported pregnancy or the intention of becoming pregnant any time during the course of this study; vii. A condition requiring the need for antibiotic premedication prior to dental procedures or use within 2 weeks of the Baseline visit; or viii. Have any condition or disease, as determined by the Investigator/Designee based on a review of the medical history which could be expected to interfere with examination procedures or with the subject's safe completion of the study.
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 DentifriceEach subject will be randomly assigned to one of three treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months. | Drug | Positive Control |
| Test Stannous Fluoride DentifriceEach subject will be randomly assigned to one of three treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months. | Drug | Test Product |
| Sodium monofluorophosphate dentifriceEach subject will be randomly assigned to one of three treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months. | Drug | Negative Control |
Primary outcome
Number of Bleeding Sites
Time frame: 1 month and 3 months
Number of Bleeding Sites
2 secondary outcomes
Loe-Silness Gingival Evaluation
Time frame: 1 month and 3 months
Turesky Plaque Evaluation
Time frame: 1 month and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
Related trials for Gingivitis
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingObservational study
Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption
Active, not recruitingObservational study
Comparison of Saliva Characteristics and Oral Health in Pregnant and Non-pregnant Women
Plaque Induced 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
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.
Nachnani principal investigator
University Health Resources Group, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stannous Fluoride Dentifrice, Test Stannous Fluoride Dentifrice and Sodium monofluorophosphate dentifrice 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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: 1 month and 3 months). 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 23 Sep 2025.