CompletedNCT06892834Updated May 4, 2026Results posted

Assessing Gingivitis of 3 Different Dentifrices Compared to a Negative Control.

A Phase 2 interventional study of Stannous Fluoride Dentifrice and Sodium Fluoride Dentifrice in Gingivitis, sponsored by Procter and Gamble. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by Procter and Gamble · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 120
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 the detailed description

The participants will be enrolled and use their assigned treatment products for 12 weeks (\~3 months).

Conditions studied

Gingivitis

Browse trials for

Gingivitis 631

In context

Gingivitis

631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.

This study's enrollment of 120 is above the median of 66 across 507 interventional studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

Procter and Gamble is the lead sponsor of 83 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Be at least 18 years of age;
Provide written 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 , agree to use a medically approved method of 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 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;
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.

Exclusion criteria

Exclusion Criteria:

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 who are not using a medically approved method of (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 ) 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;
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.

Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 120 participants (actual)

Study arms

Active comparator
Positive Control
0.454% stannous fluoride, 0.533% zinc citrate
Drug: Stannous Fluoride Dentifrice
Experimental
Experimental #1
0.243% NaF with 0.1% Hops, Humulus lupulus extract \[0.045% hops β-acids\]
Drug: Sodium Fluoride Dentifrice
Experimental
Experimental #2
0.243% NaF with 0.5% Hops, Humulus lupulus extract \[0.225% hops β-acids\]
Drug: Sodium Fluoride Dentifrice
Active comparator
Negative Control
0.76% Sodium Monofluorophosphate
Drug: Sodium monofluorophosphate dentifrice

Interventions

DrugStannous Fluoride Dentifrice
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).
DrugSodium Fluoride Dentifrice
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).
DrugSodium monofluorophosphate dentifrice
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).

What researchers measure

Primary outcomes

Number Bleeding Sites
Time frame: 4 weeks (~1 month) and 12 weeks (~3 months)

Secondary outcomes

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
Time frame: 4 weeks (~1 month) and 12 weeks (~3 months)

Results

Posted May 4, 2026

Participant flow

Participant flow — Overall Study
Milestone	Negative Control	Experimental #1	Experimental #2	Positive Control
Started	30	30	30	30
Completed	30	30	30	30
Not completed	0	0	0	0

Outcome measures

PrimaryNumber Bleeding Sites

Time frame:: 4 weeks (~1 month) and 12 weeks (~3 months)
Reported as:: Least squares mean · number of bleeding sites

Number Bleeding Sites
number of bleeding sites	Negative Control	Experimental #1	Experimental #2	Positive Control
4 weeks (~1 month)	31.52 ± 0.471	25.90 ± 0.700	21.65 ± 0.507	19.13 ± 1.017
12 weeks (~3 Months)	28.37 ± 0.555	20.18 ± 0.700	13.92 ± 0.443	9.22 ± 0.866

SecondaryLöe-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

Time frame:: 4 weeks (~1 month) and 12 weeks (~3 months)
Reported as:: Least squares mean · score on scale

Löe-Silness Gingivitis Evaluation
score on scale	Negative Control	Experimental #1	Experimental #2	Positive Control
1 Month	1.18 ± 0.006	1.11 ± 0.005	1.07 ± 0.006	1.06 ± 0.009
3 Months	1.16 ± 0.006	1.06 ± 0.007	0.98 ± 0.012	0.93 ± 0.010

Adverse events

Collected over Data collected over 12 weeks (~3 months) of product use.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Positive Control	0/30 (0%)	0/30 (0%)	2/30 (6.7%)
Experimental #1	0/30 (0%)	0/30 (0%)	0/30 (0%)
Experimental #2	0/30 (0%)	0/30 (0%)	0/30 (0%)
Negative Control	0/30 (0%)	0/30 (0%)	0/30 (0%)

Most frequent other events

Most frequent other events
Event	Positive Control	Experimental #1	Experimental #2	Negative Control
HEADACHENervous system disorders	2/30	0/30	0/30	0/30

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Negative Control	Experimental #1	Experimental #2	Positive Control	Total
Mean	46.00 ± 15.326	51.20 ± 14.639	48.23 ± 15.664	43.63 ± 16.155	47.27 ± 15.516

Sex: Female, Male
Sex: Female, Male(Participants)	Negative Control	Experimental #1	Experimental #2	Positive Control	Total
Female	20	20	22	20	82
Male	10	10	8	10	38

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Negative Control	Experimental #1	Experimental #2	Positive Control	Total
Hispanic or Latino	1	1	1	1	4
Not Hispanic or Latino	29	29	29	29	116
Unknown or Not Reported	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Negative Control	Experimental #1	Experimental #2	Positive Control	Total
American Indian or Alaska Native	0	0	0	0	0
Asian	4	6	9	8	27
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	13	5	12	11	41
White	13	18	9	11	51
More than one race	0	1	0	0	1
Unknown or Not Reported	0	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Negative Control	Experimental #1	Experimental #2	Positive Control	Total
Canada	30	30	30	30	120

Study locations

1 site

All Sum ResearchAll Sum Research Center Ltd.
Mississauga, Ontario L5N 6J2, Canada

References and documents

Study documents

Protocol and statistical analysis plan ↗ · Feb 20, 2025

PDFs hosted by the registry, ClinicalTrials.gov.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2025 to primary completion in Jun 2025, 2 months.

Results were first posted in May 2026, 10 months after primary completion.

Of 16 phase 2 interventional studies under Gingivitis, half reached primary completion within 2 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 15. This study's 2 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 19, 2025
First posted: Mar 25, 2025
StartActual: Mar 25, 2025
Primary completionActual: Jun 19, 2025
CompletionActual: Jun 19, 2025
Results first posted: May 4, 2026
Last update: May 4, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06892834
Lead sponsor: Procter and Gamble
Responsible party: Sponsor
First posted: Mar 25, 2025
Start date: Mar 25, 2025
Primary completion: Jun 19, 2025
Completion: Jun 19, 2025
Results posted: May 4, 2026
Last update: May 4, 2026

Study contacts

All Sum Research

principal investigator · All Sum Research

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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