Gingival InflammationNCT07640399
Stannous Fluoride Toothpaste for Reduction and Treatment of Gingivitis
A study testing Sodium Fluoride Dentifrice and Stannous Fluoride Toothpaste (SnF) in people with Gingival Inflammation and Plaque, run by Church & Dwight Company, Inc. at 1 site in Canada.
Trial summary
This study evaluated the efficacy of a stannous fluoride toothpaste compared to a sodium fluoride control toothpaste in reducing gingivitis, bleeding, and plaque over a 12-week period. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Inflammation, Plaque, Bleeding
- What is being tested?
- Sodium Fluoride Dentifrice and Stannous Fluoride Toothpaste (SnF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteCanada
- Study dates
- 17 Mar 2025to 13 Jun 2025
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 18 to 65 years (inclusive)
- Provided written informed consent prior to participation
- Able to brush their own teeth on a daily basis
- In good general health based on medical history review
- Minimum of at least 18 natural, scorable teeth
- Mean plaque index score ≥ 1.95
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- Mean baseline gingival index score ≥ 1.70 and ≤ 3.0
- Agreed to refrain from use of all oral hygiene products other than those supplied for the study
- Agreed to refrain from oral hygiene, eating, drinking, and chewing gum for approximately 12 hours prior to study visits
- Agreed not to undergo dental prophylaxis or elective dental procedures during the study
- Willing and able to comply with study procedures and visit schedule
Who cannot join
- Physical limitations or restrictions that preclude normal tooth brushing
- Requirement for premedication prior to dental treatment
- Pregnancy or intent to become pregnant during the study period
- Use of tobacco or nicotine products
- Poor oral hygiene defined as >40 bleeding sites
- Presence of dental caries or calculus deposits that may interfere with plaque assessments
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- Major oral hard or soft tissue lesions or trauma at baseline
- Presence of fixed or removable orthodontic appliances
- Dental prophylaxis within 1 month prior to baseline visit
- History of significant adverse events, allergy, or irritation related to oral hygiene products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Stannous Fluoride Toothpaste in the Reduction and Treatment of Gingivitis: A Randomized Controlled Trial
This study evaluated the efficacy of a stannous fluoride toothpaste compared to a sodium fluoride control toothpaste in reducing gingivitis, bleeding, and plaque over a 12-week period.
A total of 132 subjects were randomized to one of two treatment groups and assessed at baseline and at Weeks 2, 4, 8, and 12 using standardized clinical indices, including the Modified Gingival Index (MGI), Bleeding Index (BI), and Plaque Index (PI).
- Conditions
- Gingival Inflammation, Plaque, Bleeding
- Being tested
- Sodium Fluoride Dentifrice, Stannous Fluoride Toothpaste (SnF)
- Medical subject headings
- Gingivitis, Plaque, Amyloid, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Fluoride DentifriceDrug
Comparator toothpaste
Stannous Fluoride Toothpaste (SnF)Drug
Test toothpaste (0.454% SnF)
| Study group | Role | What they receive |
|---|---|---|
| Sodium Fluoride Control Dentifrice | Active comparator | Dentifrice containing sodium fluoride, serving as the control comparator Receives: Drug: Sodium Fluoride Dentifrice |
| Stannous Fluoride Toothpaste | Experimental | Dentifrice containing stannous fluoride evaluated for gingivitis effect Receives: Drug: Stannous Fluoride Toothpaste (SnF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of a stannous fluoride toothpaste in gingival inflammation
Change from baseline in whole-mouth Modified Gingival Index (MGI) score at Week 12 Whole-mouth gingival inflammation will be assessed using the Modified Gingival Index (MGI). Scores are recorded on scorable gingival areas of all scorable teeth using a 0-4 scale, and the whole-mouth MGI score is calculated as the sum of all site scores divided by the number of scorable sites examined. The primary analysis compares the change from baseline to Week 12 between treatment groups.
Measured: 12 weeks
Secondary outcomes (3)
Evaluate improvements at weeks 2, 4, 8; assess gingival bleeding at weeks 2, 4, 8, and 12 weeks
Secondary outcome measures include change from baseline in whole-mouth bleeding index at Weeks 2, 4, 8, and 12...based on scorable gingival areas using the Saxton 0-2 scale
Measured: 2, 4, 8, and 12 weeks
Evaluate improvements at weeks 2, 4, 8; assess plaque control at weeks 2, 4, 8, and 12 weeks
Secondary outcome measures include change from baseline in plaque at Weeks 2, 4, 8, and 12...calculated from disclosed plaque scores on scorable buccal and lingual tooth surfaces using the Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index; lower scores indicate improvement for all measures.
Measured: 2, 4, 8, and 12 weeks
Evaluate improvements at weeks 2, 4, 8; in whole mouth Modified Gingival Index (MGI) scores
Secondary outcome measures include change from baseline in whole-mouth MGI at Weeks 2, 4, and 8, using the Modified Gingival Index (MGI). Scores are recorded on scorable gingival areas of all scorable teeth using a 0-4 scale, and the whole-mouth MGI score is calculated as the sum of all site scores divided by the number of scorable sites examined.
Measured: 2, 4, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start17 Mar 2025
- Primary completion13 Jun 2025
- Study completion13 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival InflammationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Church & Dwight Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Annahita Ghassemi, Study director, Church & Dwight, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640399
- Sponsor's protocol ID
- ST-25-U01
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The sponsor does not plan to share individual participant data. Summary results will be provided as required, but no de identified datasets will be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Stannous Fluoride Toothpaste in the Reduction and Treatment of Gingivitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07640399
- Acronym / sponsor ID
- ST-25-U01
- Conditions
- Gingival Inflammation, Plaque, Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Church & Dwight Company, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 13 Jun 2025 (actual)
- Study completion
- 13 Jun 2025 (actual)
- First posted
- 10 Jun 2026 (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.
This study evaluated the efficacy of a stannous fluoride toothpaste compared to a sodium fluoride control toothpaste in reducing gingivitis, bleeding, and plaque over a 12-week period.
A total of 132 subjects were randomized to one of two treatment groups and assessed at baseline and at Weeks 2, 4, 8, and 12 using standardized clinical indices, including the Modified Gingival Index (MGI), Bleeding Index (BI), and Plaque Index (PI).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Fluoride Control Dentifrice | Active comparator | Drug: Sodium Fluoride DentifriceDentifrice containing sodium fluoride, serving as the control comparator |
| Stannous Fluoride Toothpaste | Experimental | Drug: Stannous Fluoride Toothpaste (SnF)Dentifrice containing stannous fluoride evaluated for gingivitis effect |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female subjects aged 18 to 65 years (inclusive)
- Provided written informed consent prior to participation
- Able to brush their own teeth on a daily basis
- In good general health based on medical history review
- Minimum of at least 18 natural, scorable teeth
Key exclusion criteria (10 listed)
- Physical limitations or restrictions that preclude normal tooth brushing
- Requirement for premedication prior to dental treatment
- Pregnancy or intent to become pregnant during the study period
- Use of tobacco or nicotine products
- Poor oral hygiene defined as >40 bleeding sites
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 |
|---|---|---|
| Sodium Fluoride DentifriceComparator toothpaste | Drug | Sodium Fluoride Control Dentifrice |
| Stannous Fluoride Toothpaste (SnF)Test toothpaste (0.454% SnF) | Drug | Stannous Fluoride Toothpaste |
Primary outcome
Evaluate the efficacy of a stannous fluoride toothpaste in gingival inflammation
Time frame: 12 weeks
Change from baseline in whole-mouth Modified Gingival Index (MGI) score at Week 12 Whole-mouth gingival inflammation will be assessed using the Modified Gingival Index (MGI). Scores are recorded on scorable gingival areas of all scorable teeth using a 0-4 scale, and the whole-mouth MGI score is calculated as the sum of all site scores divided by the number of scorable sites examined. The primary analysis compares the change from baseline to Week 12 between treatment groups.
3 secondary outcomes
Evaluate improvements at weeks 2, 4, 8; assess gingival bleeding at weeks 2, 4, 8, and 12 weeks
Time frame: 2, 4, 8, and 12 weeks
Evaluate improvements at weeks 2, 4, 8; assess plaque control at weeks 2, 4, 8, and 12 weeks
Time frame: 2, 4, 8, and 12 weeks
Evaluate improvements at weeks 2, 4, 8; in whole mouth Modified Gingival Index (MGI) scores
Time frame: 2, 4, and 8 weeks
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 10 Jun 2026.
- Individual participant dataSharing planned: No. The sponsor does not plan to share individual participant data. Summary results will be provided as required, but no de identified datasets will be made publicly available.
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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.
Annahita Ghassemi study director
Church & Dwight, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Fluoride Dentifrice and Stannous Fluoride Toothpaste (SnF) in people with Gingival Inflammation and Plaque, run by Church & Dwight Company, Inc. at 1 site in Canada.
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 11 inclusion and 10 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 10 Jun 2026. 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 Canada. 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?
Evaluate the efficacy of a stannous fluoride toothpaste in gingival inflammation (time frame: 12 weeks). 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 10 Jun 2026.