GingivitisPhase 2NCT06892834
Assessing Gingivitis of 3 Different Dentifrices Compared to a Negative Control.
A Phase 2 study testing Stannous Fluoride Dentifrice, Sodium Fluoride Dentifrice and Sodium monofluorophosphate dentifrice in people with Gingivitis, run by Procter and Gamble at 1 site in Canada.
Trial summary
The primary objective of this study is to evaluate the effect of two experimental hops extract-containing dentifrices on gingivitis relative to a positive control 0.454% SnF2 dentifrice and a negative control dentifrice 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, Sodium Fluoride Dentifrice and Sodium monofluorophosphate dentifrice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 25 Mar 2025to 19 Jun 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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; If female of child-bearing potential, agree to use a medically approved method of birth control for the duration of the study. Acceptable methods of medically approved birth control include: at least 3 months of use of a hormonal birth control (including oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormone implant), double-barrier method, intrauterine devices, non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s), vasectomy of partner at least 6 months prior to screening. Not applicable to females not of child-bearing potential (females who have undergone a sterilization procedure including hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior;
- If female and of child-bearing potential, agree to immediately inform the study investigator if they become pregnant;
- Have at least 20 gradable teeth;
- Have mild to moderate gingivitis with a range of 10 to 70% bleeding sites;
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- 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; regular floss users can continue to floss in their customary manner.
- Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study; and
- Agree to refrain from any oral hygiene the morning of each visit.
Who cannot join
- Having taken antibiotic, anti-inflammatory, or anticoagulant medications 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, severe gingivitis, or advanced periodontal disease;
- Females of child-bearing potential who are not using a medically approved method of birth control (i.e., hormonal contraceptives including oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormone implant, double-barrier method, intrauterine devices, non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s), vasectomy of partner at least 6 months prior to screening) or who have not been using hormonal birth control for a minimum of 3 months prior to study enrollment;
- Taking medication that alters gingival appearance or gingival bleeding (e.g., calcium channel blockers, anticonvulsants, or immunosuppressants) within one month prior to study initiation;
- Regularly (>5x/week) using anti-gingivitis treatments (e.g., stannous fluoride toothpaste, or anti-gingivitis mouthwashes, such as those containing chlorohexidine) in the month prior to screening;
- Removable oral appliances;
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- Fixed facial or lingual orthodontic appliances;
- Have a positive pregnancy test (Clearblue) at baseline or self-reported pregnancy during the study; ;
- Any diseases or condition that might interfere with the safe participation in the study according to the study investigator;
- Inability to undergo study procedures; and
- Allergic reactions to any of the study toothpastes and/or ingredients in the study toothpastes.
Trial locations and contacts
1 site in 1 country.
Canada1 site
All Sum ResearchAll Sum Research Center Ltd.
Mississauga, Ontario, L5N 6J2
About this study
Official title: A Three-month Clinical Study to Assess the Gingivitis Effect of Various Dentifrices.
The primary objective of this study is to evaluate the effect of two experimental hops extract-containing dentifrices on gingivitis relative to a positive control 0.454% SnF2 dentifrice and a negative control dentifrice after 12 weeks of product use.
Read the detailed description
The participants will be enrolled and use their assigned treatment products for 12 weeks (~3 months).
- Conditions
- Gingivitis
- Being tested
- Stannous Fluoride Dentifrice, Sodium 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 four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 12 weeks (~3 months).
Sodium Fluoride DentifriceDrug
Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 12 weeks (~3 months).
Sodium monofluorophosphate dentifriceDrug
Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 12 weeks (~3 months).
| Study group | Role | What they receive |
|---|---|---|
| Positive Control | Active comparator | 0.454% stannous fluoride, 0.533% zinc citrate Receives: Drug: Stannous Fluoride Dentifrice |
| Experimental #1 | Experimental | 0.243% NaF with 0.1% Hops, Humulus lupulus extract [0.045% hops β-acids] Receives: Drug: Sodium Fluoride Dentifrice |
| Experimental #2 | Experimental | 0.243% NaF with 0.5% Hops, Humulus lupulus extract [0.225% hops β-acids] Receives: Drug: Sodium Fluoride Dentifrice |
| Negative Control | Active comparator | 0.76% Sodium Monofluorophosphate Receives: Drug: Sodium monofluorophosphate dentifrice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Bleeding Sites
Measured: 4 weeks (~1 month) and 12 weeks (~3 months)
Secondary outcomes (1)
Löe-Silness Gingivitis Evaluation
scored on a scale of 0-3; 0 Normal gingiva; 1 Mild inflammation - slight change in colour, slight edema. No bleeding on probing; 2 Moderate inflammation - redness, edema, and glazing. Bleeding on probing; 3 Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding
Measured: 4 weeks (~1 month) and 12 weeks (~3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start25 Mar 2025
- Primary completion19 Jun 2025
- Study completion19 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- All Sum Research, Principal investigator, All Sum Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892834
- Sponsor's protocol ID
- 2024026
- Status last verified
- Jun 2025
- First submitted
- 19 Mar 2025
- Last updated
- 4 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-month Clinical Study to Assess the Gingivitis Effect of Various Dentifrices.
- ClinicalTrials.gov ID
- NCT06892834
- Acronym / sponsor ID
- 2024026
- Conditions
- Gingivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 25 Mar 2025 (actual)
- Results
- Posted 4 May 2026
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 experimental hops extract-containing dentifrices on gingivitis relative to a positive control 0.454% SnF2 dentifrice and a negative control dentifrice after 12 weeks of product use.
Detailed description
The participants will be enrolled and use their assigned treatment products for 12 weeks (~3 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Positive Control | Active comparator | Drug: Stannous Fluoride Dentifrice0.454% stannous fluoride, 0.533% zinc citrate |
| Experimental #1 | Experimental | Drug: Sodium Fluoride Dentifrice0.243% NaF with 0.1% Hops, Humulus lupulus extract [0.045% hops β-acids] |
| Experimental #2 | Experimental | Drug: Sodium Fluoride Dentifrice0.243% NaF with 0.5% Hops, Humulus lupulus extract [0.225% hops β-acids] |
| Negative Control | Active comparator | Drug: Sodium monofluorophosphate dentifrice0.76% Sodium Monofluorophosphate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 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; If female of child-bearing potential, agree to use a medically approved method of birth control for the duration of the study. Acceptable methods of medically approved birth control include: at least 3 months of use of a hormonal birth control (including oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormone implant), double-barrier method, intrauterine devices, non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s), vasectomy of partner at least 6 months prior to screening. Not applicable to females not of child-bearing potential (females who have undergone a sterilization procedure including hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior;
- If female and of child-bearing potential, agree to immediately inform the study investigator if they become pregnant;
- Have at least 20 gradable teeth;
Key exclusion criteria (11 listed)
- Having taken antibiotic, anti-inflammatory, or anticoagulant medications 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, severe gingivitis, or advanced periodontal disease;
- Females of child-bearing potential who are not using a medically approved method of birth control (i.e., hormonal contraceptives including oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormone implant, double-barrier method, intrauterine devices, non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s), vasectomy of partner at least 6 months prior to screening) or who have not been using hormonal birth control for a minimum of 3 months prior to study enrollment;
- Taking medication that alters gingival appearance or gingival bleeding (e.g., calcium channel blockers, anticonvulsants, or immunosuppressants) within one month prior to study initiation;
- Regularly (>5x/week) using anti-gingivitis treatments (e.g., stannous fluoride toothpaste, or anti-gingivitis mouthwashes, such as those containing chlorohexidine) in the month prior to screening;
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 four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 12 weeks (~3 months). | Drug | Positive Control |
| Sodium Fluoride DentifriceEach subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 12 weeks (~3 months). | Drug | Experimental #1, Experimental #2 |
| Sodium monofluorophosphate dentifriceEach subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 12 weeks (~3 months). | Drug | Negative Control |
Primary outcome
Number Bleeding Sites
Time frame: 4 weeks (~1 month) and 12 weeks (~3 months)
1 secondary outcome
Löe-Silness Gingivitis Evaluation
Time frame: 4 weeks (~1 month) and 12 weeks (~3 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
All Sum Research principal investigator
All Sum Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stannous Fluoride Dentifrice, Sodium Fluoride Dentifrice and Sodium monofluorophosphate dentifrice in people with Gingivitis, run by Procter and Gamble 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 10 inclusion and 11 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 4 May 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Bleeding Sites (time frame: 4 weeks (~1 month) and 12 weeks (~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 4 May 2026.