Dental PlaqueNCT07704905
A Study to Investigate the Efficacy of an Experimental Dentifrice Containing Stannous Fluoride in Improving Gingival Health
A study testing Test Dentifrice and Reference Dentifrice (Colgate Cavity Protection Dentifrice) in people with Dental Plaque and Gingivitis, run by HALEON at 1 site in United States.
Trial summary
The aim of this study will be to evaluate the ability of using an experimental dentifrice containing 0.454 percent (%) weight for weight (w/w) Stannous Fluoride (SnF2) to reduce gingivitis and plaque accumulation, compared with a regular fluoride toothpaste (negative control) in participants with mild to moderate… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Gingivitis
- What is being tested?
- Test Dentifrice and Reference Dentifrice (Colgate Cavity Protection Dentifrice)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2026to 30 Sep 2026
- 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
- Participant provision of a signed and dated informed consent document indicating that the participant will have been informed of all pertinent aspects of the study before any assessment is performed.
- A participant who is willing and able to comply with scheduled visits, treatment plan and other study procedures, study restrictions, Lifestyle considerations.
- A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the participant's ability to understand and follow study procedures and requirements.
Who cannot join
- A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
- A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
- A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical, psychiatric condition or laboratory abnormality or any other clinical serious or unstable conditions (Example(e.g.), cardiovascular diseases, diabetes, liver disorders, and kidney disorders) that may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
- A participant who is a pregnant female (self-reported) or intending to become pregnant over the duration of the study.
- A female participant who is breastfeeding.
- A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Show all 27Show fewer
- A participant unwilling or unable to comply with the lifestyle considerations described in this protocol.
- A participant who is a current smoker or an ex-smoker (including vaping) who stopped within 6 months of Screening.
- A participant who is using smokeless forms of tobacco (example, chewing tobacco, gutkha, paan containing tobacco, nicotine-based e-cigarettes).
- A participant who has diagnosed xerostomia or is taking any medication that in the view of the investigator, is causing xerostomia.
- A participant who has a medical condition which could directly influenced gingival bleeding (e.g., type 2 diabetes).
- A participant who has a bleeding disorder that could affected study outcomes and/or participant safety.
- A participant who has a recent history (within the last year) of alcohol or other substance abuse.
- A participant who has a severe oral condition (e.g., acute necrotizing ulcerative gingivitis or oral or peri-oral ulceration including herpetic lesions) that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant/examiner if they participate in the study.
- Presence of a tongue or lip piercing, or any other oral feature that could interfere with the usage of a toothbrush.
- A participant currently taking any such medication or oral care product which in opinion of the investigator could affect gingival condition.
- Dental exclusions:
- A participant who has active caries that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant if they participate in the study.
- A participant who has dentures (partial or full).
- A participant who has fixed orthodontic appliances or is undergoing active or recent (within 3 months of Screening) orthodontic treatment, which, in the opinion of the investigator, could interfere with study procedures, assessments or outcomes.
- A participant who has other orthodontic devices (e.g., bands, fixed retainers, or removable retainers) that could, in the opinion of the investigator, interferes with study procedures, assessment, or outcomes.
- A participant who has numerous restorations in a poor state of repair.
- A participant who has any dental condition (e.g., overcrowding) that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant if they participate in the study.
- A participant who has had dental prophylaxis and teeth bleaching within 12 weeks of Screening.
- A participant who has high levels of extrinsic stain or calculus deposits, in the opinion of the investigator, that could interfered with plaque assessments.
- A participant who has previously been enrolled in this study.
- A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An 8-Week Randomized, Controlled, Examiner-Blind, Clinical Study Investigating the Efficacy of an Experimental Dentifrice Containing Stannous Fluoride in Improving Gingival Health
The aim of this study will be to evaluate the ability of using an experimental dentifrice containing 0.454 percent (%) weight for weight (w/w) Stannous Fluoride (SnF2) to reduce gingivitis and plaque accumulation, compared with a regular fluoride toothpaste (negative control) in participants with mild to moderate gingivitis.
Read the detailed description
This will be a single-center, 8-week randomized, controlled, single blind (examiner only), 2-treatment arm, parallel group, stratified study, to evaluate the efficacy of using an experimental dentifrice containing 0.454% w/w Stannous Fluoride, twice daily in reducing gingivitis and plaque accumulation in a population with a clinically measurable level of gingivitis. The clinical efficacy of the experimental dentifrice will be compared to a commercially available regular fluoride dentifrice as negative control. Sufficient participants will be screened to randomize approximately 110 participants (approximately 55 per group) to ensure approximately 100 evaluable participants (approximately 50 per group) complete the study.
- Conditions
- Dental Plaque, Gingivitis
- Being tested
- Test Dentifrice, Reference Dentifrice (Colgate Cavity Protection Dentifrice)
- Medical subject headings
- Dental Plaque, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test DentifriceDrug
Experimental dentifrice containing 0.454% w/w SnF2.
Reference Dentifrice (Colgate Cavity Protection Dentifrice)Drug
A marketed regular fluoride dentifrice.
| Study group | Role | What they receive |
|---|---|---|
| Test Dentifrice | Experimental | Participants will brush their teeth thoroughly for at least one timed minute twice daily (morning and evening) for 8 Weeks, using a full ribbon of Test Dentifrice on the head of the toothbrush provided. Receives: Drug: Test Dentifrice |
| Reference Dentifrice | Active comparator | Participants will brush their teeth thoroughly for at least one timed minute twice daily (morning and evening) for 8 Weeks, using a full ribbon of Reference Dentifrice on the head of the toothbrush provided. Receives: Drug: Reference Dentifrice (Colgate Cavity Protection Dentifrice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Overall Modified Gingival Index (MGI) at Week 8
The MGI assessment is a non-invasive visual evaluation to assess the symptoms of gingivitis. It will be assessed on all scorable teeth. For each tooth, 3 scores will be recorded and will be scored on a 5-point scale ranging from 0 to 4, where 0 equals (=) Absence of inflammation, 1= Mild inflammation; slight or little change in color; little change in texture of any portion of the marginal/ papillary gingival unit, 2= Mild inflammation; criteria as above, but involving the entire marginal/ papillary gingival unit, 3= Moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal/ papillary gingival unit, 4= Severe inflammation; marked redness, edema and/ or hypertrophy of the marginal/ papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Change from Baseline= Week 8 score minus Baseline score. Lower scores indicate symptom improvement.
Measured: Baseline and Week 8
Secondary outcomes (3)
Change from Baseline in Interproximal MGI at Week 8
The MGI assessment is a non-invasive visual evaluation to assess the symptoms of gingivitis. It will be assessed on all scorable teeth. For each tooth, 3 scores will be recorded and will be scored on a 5-point scale ranging from 0 to 4, where 0= Absence of inflammation, 1= Mild inflammation; slight or little change in color; little change in texture of any portion of the marginal/ papillary gingival unit, 2= Mild inflammation; criteria as above, but involving the entire marginal/ papillary gingival unit, 3= Moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal/ papillary gingival unit, 4= Severe inflammation; marked redness, edema and/ or hypertrophy of the marginal/ papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Change from Baseline= Week 8 score minus Baseline score. Lower scores will indicate symptom improvement.
Measured: Baseline and Week 8
Change from Baseline in Overall Turesky Modification of the Quigley Hein Plaque Index (TPI) at Week 8
TPI will be used to assess plaque on all gradable teeth. The plaque will first be disclosed using a plaque disclosing dye solution. The TPI will be assessed on the facial and lingual surfaces of each scorable tooth. Three scores will be recorded buccally/labially and three scores lingually/palatally. The disclosed plaques will be scored using a 6-point scale ranging from 0 to 5, where 0= No plaque, 1= Separate flecks of plaque at the cervical margin, 2= Thin continuous band of plaque (up to 1 millimeter[mm]) at the cervical margin, 3= Band of plaque wider than 1 mm but covering less than (<) 1/3 of the tooth surface, 4= Plaque covering greater than or equal to (≥) 1/3 but < 2/3 of the tooth surface, 5= Plaque covering ≥ 2/3 of the tooth surface. Change from Baseline= Week 8 score minus Baseline score. Lower scores will indicate symptom improvement.
Measured: Baseline and Week 8
Change from Baseline in Interproximal TPI at Week 8
TPI will be used to assess plaque on all gradable teeth. The plaque will first be disclosed using a plaque disclosing dye solution. The TPI will be assessed on the facial and lingual surfaces of each scorable tooth. Three scores will be recorded buccally/labially and three scores lingually/palatally. The disclosed plaques will be scored using a 6-point scale ranging from 0 to 5, where 0= No plaque, 1= Separate flecks of plaque at the cervical margin, 2= Thin continuous band of plaque (up to 1 mm) at the cervical margin, 3= Band of plaque wider than 1 mm but covering < 1/3 of the tooth surface, 4= Plaque covering ≥ 1/3 but < 2/3 of the tooth surface, 5= Plaque covering ≥ 2/3 of the tooth surface. Change from Baseline= Week 8 score minus Baseline score. Lower scores will indicate symptom improvement.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start13 Jul 2026
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- More trials run by HALEONThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffery L Milleman, DDS, Principal investigator, Salus Research Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704905
- Sponsor's protocol ID
- 400347
- Status last verified
- Oct 2026
- First submitted
- 10 Jul 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-Week Randomized, Controlled, Examiner-Blind, Clinical Study Investigating the Efficacy of an Experimental Dentifrice Containing Stannous Fluoride in Improving Gingival Health
- ClinicalTrials.gov ID
- NCT07704905
- Acronym / sponsor ID
- 400347
- Conditions
- Dental Plaque, Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 15 Jul 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.
The aim of this study will be to evaluate the ability of using an experimental dentifrice containing 0.454 percent (%) weight for weight (w/w) Stannous Fluoride (SnF2) to reduce gingivitis and plaque accumulation, compared with a regular fluoride toothpaste (negative control) in participants with mild to moderate gingivitis.
Detailed description
This will be a single-center, 8-week randomized, controlled, single blind (examiner only), 2-treatment arm, parallel group, stratified study, to evaluate the efficacy of using an experimental dentifrice containing 0.454% w/w Stannous Fluoride, twice daily in reducing gingivitis and plaque accumulation in a population with a clinically measurable level of gingivitis. The clinical efficacy of the experimental dentifrice will be compared to a commercially available regular fluoride dentifrice as negative control. Sufficient participants will be screened to randomize approximately 110 participants (approximately 55 per group) to ensure approximately 100 evaluable participants (approximately 50 per group) complete the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Dentifrice | Experimental | Drug: Test DentifriceParticipants will brush their teeth thoroughly for at least one timed minute twice daily (morning and evening) for 8 Weeks, using a full ribbon of Test Dentifrice on the head of the toothbrush provided. |
| Reference Dentifrice | Active comparator | Drug: Reference Dentifrice (Colgate Cavity Protection Dentifrice)Participants will brush their teeth thoroughly for at least one timed minute twice daily (morning and evening) for 8 Weeks, using a full ribbon of Reference Dentifrice on the head of the toothbrush provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant provision of a signed and dated informed consent document indicating that the participant will have been informed of all pertinent aspects of the study before any assessment is performed.
- A participant who is willing and able to comply with scheduled visits, treatment plan and other study procedures, study restrictions, Lifestyle considerations.
- A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the participant's ability to understand and follow study procedures and requirements.
Key exclusion criteria (27 listed)
- A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
- A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
- A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical, psychiatric condition or laboratory abnormality or any other clinical serious or unstable conditions (Example(e.g.), cardiovascular diseases, diabetes, liver disorders, and kidney disorders) that may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
- A participant who is a pregnant female (self-reported) or intending to become pregnant over the duration of the study.
- A female participant who is breastfeeding.
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 |
|---|---|---|
| Test DentifriceExperimental dentifrice containing 0.454% w/w SnF2. | Drug | Test Dentifrice |
| Reference Dentifrice (Colgate Cavity Protection Dentifrice)A marketed regular fluoride dentifrice. | Drug | Reference Dentifrice |
Primary outcome
Change from Baseline in Overall Modified Gingival Index (MGI) at Week 8
Time frame: Baseline and Week 8
The MGI assessment is a non-invasive visual evaluation to assess the symptoms of gingivitis. It will be assessed on all scorable teeth. For each tooth, 3 scores will be recorded and will be scored on a 5-point scale ranging from 0 to 4, where 0 equals (=) Absence of inflammation, 1= Mild inflammation; slight or little change in color; little change in texture of any portion of the marginal/ papillary gingival unit, 2= Mild inflammation; criteria as above, but involving the entire marginal/ papillary gingival unit, 3= Moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal/ papillary gingival unit, 4= Severe inflammation; marked redness, edema and/ or hypertrophy of the marginal/ papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Change from Baseline= Week 8 score minus Baseline score. Lower scores indicate symptom improvement.
3 secondary outcomes
Change from Baseline in Interproximal MGI at Week 8
Time frame: Baseline and Week 8
Change from Baseline in Overall Turesky Modification of the Quigley Hein Plaque Index (TPI) at Week 8
Time frame: Baseline and Week 8
Change from Baseline in Interproximal TPI at Week 8
Time frame: Baseline and Week 8
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 7 Oct 2026.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com.
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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.
Jeffery L Milleman, DDS principal investigator
Salus Research 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 Test Dentifrice and Reference Dentifrice (Colgate Cavity Protection Dentifrice) in people with Dental Plaque and Gingivitis, run by HALEON 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 3 inclusion and 27 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 7 Oct 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 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.
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?
Change from Baseline in Overall Modified Gingival Index (MGI) at Week 8 (time frame: Baseline and Week 8). 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 7 Oct 2026.