Dental PlaqueNCT06602466
A Clinical Study Investigating the Effect of an Experimental Toothpaste Containing Stannous Fluoride in Improving Gingival Health
A study testing Test toothpaste and Colgate Cavity Protection Toothpaste in people with Dental Plaque and Gingivitis, run by HALEON at 1 site in United Kingdom.
Trial summary
The aim of this 4-week clinical study is to evaluate the ability of an experimental toothpaste, containing 0.454 percent (%) Stannous Fluoride (SnF2), 0.3% Zinc Chloride (ZnCl2) and 1% Alumina, to improve gingival health and plaque accumulation compared to a regular fluoride toothpaste (negative control) in… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Gingivitis
- What is being tested?
- Test toothpaste and Colgate Cavity Protection Toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Sep 2024to 13 Dec 2024
- Phase
- Interventional
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- Biological sex at birth was male or female.
- Aged 18 to 70 years inclusive, at the signing of the informed consent.
- Willing and able to comply with scheduled visits, treatment plan, saliva sample collection, study restrictions, Lifestyle Considerations and other study procedures.
- 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 individual's ability to understand and follow study procedures and requirements.
- Participant oral health that meets all the following:
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- At Screening (Visit 1):
- Participant with at least 20 natural, permanent teeth, (excluding 3rd molars).
- Participant with at least 40 evaluable surfaces for MGI, BI, and TPI.
- A healthy participant with mild to moderate plaque-induced gingivitis in the opinion of the clinical examiner.
- Overall MGI less than or equal to (<=) 1.75 to <= 2.30
- At Baseline (Visit 2):
- Overall MGI greater than or equal to (>=) 1.75 to <= 2.30
- Overall TPI score >= 1.5
Who cannot join
- 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 or psychiatric condition or laboratory abnormality 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 has any other clinical serious or unstable conditions (for example, cardiovascular diseases, diabetes, liver disorders, and kidney disorders) which could have affected study outcomes and/or participant safety.
- A participant who is pregnant (self-reported) or intending to become pregnant over the duration of the study.
- A participant who is breastfeeding.
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- A participant with known or suspected intolerance or hypersensitivity to any study materials (or closely related compounds) or any of their stated ingredients.
- 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 vaper) who stopped within 6 months of Screening.
- A participant who is using smokeless forms of tobacco (for example, chewing tobacco, gutkha, pan containing tobacco, nicotine-based e-cigarettes).
- A participant who is 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 have directly influenced gingival bleeding.
- A participant who has a bleeding disorder that could have 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 (for example, 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.
- Medications exclusions: At Screening (Visit 1):
- A participant using any antibiotic medication within 28 days prior to screening or at any time during the study.
- Participant who has used an anti-bacterial toothpaste/mouthwash (for example, chlorhexidine) or another oral care product within 2 weeks of Screening that, in the opinion of the investigator or dentally qualified designee, could affect gingival health, plaque formation or oral bacteria.
- A participant currently taking an anti-inflammatory medication which, in the opinion of the Investigator, could affect gingival condition.
- A participant currently taking a systemic medication (for example, anti-inflammatory, anticoagulant, immunosuppressants) or traditional/ herbal remedy which, in the opinion of the Investigator, could affect plaque/ gingival condition (for example, ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers, statins).
- Medications exclusions: At Baseline (Visit 2):
- A participant who has taken any antibiotics during the washout period (between Screening and Baseline).
- A participant who has taken (in the previous 14 days) a systemic medication (for example, anti-inflammatory, anti-coagulant, immunosuppressants) or traditional/ herbal remedy which, in the opinion of the Investigator, could affect plaque/ gingival condition (for example, ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers).
- A participant who has used an antibacterial dentifrice or mouthwash (for example, chlorhexidine) or any oral care product that in the view of the investigator could interfere with gingival health, plaque formation and oral bacteria, in the period between Screening and the Baseline visit.
- Periodontal exclusions:
- A participant who shows signs of periodontitis [at both Screening (Visit 1) and Baseline visits (Visit 2)].
- A participant with a Basic Periodontal Examination (BPE) score of 4 or above in one or more sextants.
- A participant with BPE score >= 3, if with probing pocket, a single tooth dept is >= 5 mm.
- A participant who is receiving or has received treatment for periodontal disease (including surgery) within 12 months of Screening.
- A participant who has gingivitis, which in the opinion of the investigator, is not expected to respond to treatment with an over the counter (OTC) dentifrice.
- 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 an orthodontic appliance (bands, appliances, or fixed/ removable retainers).
- A participant who received orthodontic therapy within 3 months of Screening.
- A participant who has numerous restorations in a poor state of repair.
- A participant who has any dental condition (for example, 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 within 12 weeks of Screening.
- A participant who has had 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 have 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: A 4-Week Randomised, Controlled, Examiner-blind, Clinical Study Investigating the Efficacy of an Experimental Toothpaste Containing Stannous Fluoride in Improving Gingival Health
The aim of this 4-week clinical study is to evaluate the ability of an experimental toothpaste, containing 0.454 percent (%) Stannous Fluoride (SnF2), 0.3% Zinc Chloride (ZnCl2) and 1% Alumina, to improve gingival health and plaque accumulation compared to a regular fluoride toothpaste (negative control) in participants with plaque-induced mild to moderate gingivitis.
Read the detailed description
This will be a single-center, 4 weeks, randomized, controlled, examiner-blind, 2 treatment arms, stratified, parallel group design clinical study, investigating gingival health and supra-gingival plaque reduction on healthy participants after using an experimental toothpaste containing 0.454% SnF2, 0.3% ZnCl2 and 1% Alumina. Sufficient participants will be screened so that at least 160 participants are randomized (approximately 80 per group) to ensure approximately 144 (approximately 72 per group) evaluable participants complete the entire study.
- Conditions
- Dental Plaque, Gingivitis
- Being tested
- Test toothpaste, Colgate Cavity Protection Toothpaste
- 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 toothpasteDrug
0.454% Stannous Fluoride, 0.3% Zinc Chloride,1% Alumina toothpaste containing 1100 parts per million (ppm) fluoride.
Colgate Cavity Protection ToothpasteDrug
Commercial toothpaste containing 1450 ppm fluoride.
| Study group | Role | What they receive |
|---|---|---|
| Test Toothpaste | Experimental | Participants will brush their teeth with full ribbon of test toothpaste on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks. Receives: Drug: Test toothpaste |
| Reference Toothpaste (Negative Control) | Active comparator | Participants will brush their teeth with full ribbon of reference toothpaste (Colgate Cavity Protection) on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks. Receives: Drug: Colgate Cavity Protection Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjusted Mean Bleeding Index (BI) at Week 4
The BI is an invasive assessment of gingival bleeding performed using a round-end probe. Presence/absence of gingival bleeding was assessed for 30 seconds after probing. BI was assessed on 3-points scale ranging from 0 to 2, where 0= Absence of bleeding on probing, 1= Bleeding observed within 30 seconds of probing, 2= Bleeding observed immediately on probing. Mean BI was calculated by taking the average over all tooth sites assessed for a participant. Lower score indicated improvement in the symptoms. Adjusted mean value was derived using ANCOVA model.
Measured: Week 4
Secondary outcomes (4)
Adjusted Mean Number of Bleeding Sites (NBS) at Week 4
The bleeding assessment was done using round-end probe. The number of bleeding sites for each participant= the number of evaluable tooth sites with bleeding observed immediately on probing or within 30 seconds of probing. Adjusted mean value was derived using ANCOVA model.
Measured: Week 4
Adjusted Mean Modified Gingival Index (MGI) at Week 4
The MGI is a non-invasive visual assessment of gingival inflammation. MGI was assessed for all evaluable surfaces, four sites per tooth and was scored on a 5-point scale ranging from 0 to 4, where 0= Absence of inflammation, 4= Severe inflammation. Lower score indicated improvement in the symptoms. Adjusted mean value was derived using ANCOVA model.
Measured: Week 4
Adjusted Mean Overall Turesky Plaque Index (TPI) at Week 4
The TPI is a non-invasive assessment of supra-gingival plaque accumulation. The plaque was disclosed using a plaque disclosing dye solution and the TPI was assessed using a 6-point scale ranging from 0 to 5, where 0= No plaque, 5= Plaque covering 2/3 or more of the crown of the tooth. Lower score indicated improvement in the symptoms. Adjusted mean value was derived using ANCOVA model.
Measured: Week 4
Adjusted Mean Interproximal TPI at Week 4
The TPI is a non-invasive assessment of supra-gingival plaque accumulation. The plaque was disclosed using a plaque disclosing dye solution and the TPI was assessed using a 6-point scale ranging from 0 to 5, where 0= No plaque, 5= Plaque covering 2/3 or more of the crown of the tooth. Lower score indicated improvement in the symptoms. Adjusted mean value was derived using ANCOVA model.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start23 Sep 2024
- Primary completion13 Dec 2024
- Study completion13 Dec 2024
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 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
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602466
- Sponsor's protocol ID
- 300178
- Status last verified
- Jan 2026
- First submitted
- 17 Sep 2024
- Last updated
- 22 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-Week Randomised, Controlled, Examiner-blind, Clinical Study Investigating the Efficacy of an Experimental Toothpaste Containing Stannous Fluoride in Improving Gingival Health
- ClinicalTrials.gov ID
- NCT06602466
- Acronym / sponsor ID
- 300178
- Conditions
- Dental Plaque, Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Posted 22 Jan 2026
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 4-week clinical study is to evaluate the ability of an experimental toothpaste, containing 0.454 percent (%) Stannous Fluoride (SnF2), 0.3% Zinc Chloride (ZnCl2) and 1% Alumina, to improve gingival health and plaque accumulation compared to a regular fluoride toothpaste (negative control) in participants with plaque-induced mild to moderate gingivitis.
Detailed description
This will be a single-center, 4 weeks, randomized, controlled, examiner-blind, 2 treatment arms, stratified, parallel group design clinical study, investigating gingival health and supra-gingival plaque reduction on healthy participants after using an experimental toothpaste containing 0.454% SnF2, 0.3% ZnCl2 and 1% Alumina. Sufficient participants will be screened so that at least 160 participants are randomized (approximately 80 per group) to ensure approximately 144 (approximately 72 per group) evaluable participants complete the entire study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Toothpaste | Experimental | Drug: Test toothpasteParticipants will brush their teeth with full ribbon of test toothpaste on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks. |
| Reference Toothpaste (Negative Control) | Active comparator | Drug: Colgate Cavity Protection ToothpasteParticipants will brush their teeth with full ribbon of reference toothpaste (Colgate Cavity Protection) on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- Biological sex at birth was male or female.
- Aged 18 to 70 years inclusive, at the signing of the informed consent.
- Willing and able to comply with scheduled visits, treatment plan, saliva sample collection, study restrictions, Lifestyle Considerations and other study procedures.
- 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 individual's ability to understand and follow study procedures and requirements.
Key exclusion criteria (43 listed)
- 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 or psychiatric condition or laboratory abnormality 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 has any other clinical serious or unstable conditions (for example, cardiovascular diseases, diabetes, liver disorders, and kidney disorders) which could have affected study outcomes and/or participant safety.
- A participant who is pregnant (self-reported) or intending to become pregnant over the duration 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 |
|---|---|---|
| Test toothpaste0.454% Stannous Fluoride, 0.3% Zinc Chloride,1% Alumina toothpaste containing 1100 parts per million (ppm) fluoride. | Drug | Test Toothpaste |
| Colgate Cavity Protection ToothpasteCommercial toothpaste containing 1450 ppm fluoride. | Drug | Reference Toothpaste (Negative Control) |
Primary outcome
Adjusted Mean Bleeding Index (BI) at Week 4
Time frame: Week 4
The BI is an invasive assessment of gingival bleeding performed using a round-end probe. Presence/absence of gingival bleeding was assessed for 30 seconds after probing. BI was assessed on 3-points scale ranging from 0 to 2, where 0= Absence of bleeding on probing, 1= Bleeding observed within 30 seconds of probing, 2= Bleeding observed immediately on probing. Mean BI was calculated by taking the average over all tooth sites assessed for a participant. Lower score indicated improvement in the symptoms. Adjusted mean value was derived using ANCOVA model.
4 secondary outcomes
Adjusted Mean Number of Bleeding Sites (NBS) at Week 4
Time frame: Week 4
Adjusted Mean Modified Gingival Index (MGI) at Week 4
Time frame: Week 4
Adjusted Mean Overall Turesky Plaque Index (TPI) at Week 4
Time frame: Week 4
Adjusted Mean Interproximal TPI at Week 4
Time frame: Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 toothpaste and Colgate Cavity Protection Toothpaste in people with Dental Plaque and Gingivitis, run by HALEON at 1 site in United Kingdom.
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 14 inclusion and 43 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 22 Jan 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 Kingdom. 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?
Yes. Results are posted in the registry (first posted 22 Jan 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?
Adjusted Mean Bleeding Index (BI) at Week 4 (time frame: Week 4). 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 22 Jan 2026.