GingivitisNCT06143670
A Clinical Study Investigating the Effects of a Dentifrice Containing 0.454% Stannous Fluoride on Gingivitis Treatment and Plaque Reduction When Used Twice Daily for 12 Weeks
A study testing Stannous fluoride toothpaste and Sodium fluoride toothpaste in people with Gingivitis, run by HALEON at 1 site in United States.
Trial summary
The purpose of this clinical study is to investigate the efficacy of a dentifrice containing 0.454 percent (%) weight by weight (w/w) stannous fluoride (SnF2), on gingivitis treatment and plaque reduction, compared to a regular fluoride dentifrice after 12 weeks twice daily brushing in a population of clinically… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingivitis
- What is being tested?
- Stannous fluoride toothpaste and Sodium fluoride toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2023to 12 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant 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.
- Participant is of either sex and any gender who, at the time of screening, is at least 18 years old, inclusive.
- A participant who is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant/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.
- Participant oral health that meets all the following:
- At Screening (Visit 1):
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- Participant with at least 20 natural, permanent teeth.
- Participant with at least 40 evaluable surfaces for MGI, BI, and TPI (An evaluable surface is defined as having two thirds of the natural tooth surface gradable for the selected clinical indices. The following will not be included in the evaluable surface count: third molars; fully crowned/extensively restored, grossly carious, orthodontically banded/bonded or abutment teeth; surfaces with calculus deposits which, in the opinion of the clinical examiner, would interfere with the baseline assessments of the selected clinical indices).
- A participant with plaque-induced gingivitis, in the opinion of the clinical examiner, as confirmed by a gross visual examination.
- At Baseline (Visit 2):
- A participant with ongoing hard tissue eligibility and, in the opinion of the clinical examiner, at least 40 evaluable surfaces.
- A participant with 10% to 30% bleeding sites (following BI).
- A participant with mean whole mouth TPI score >=1.5.
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 sponsor's 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 a pregnant female (self-reported) or is intending to become pregnant over the duration of the study.
- A participant who is a breastfeeding female.
Show all 40Show fewer
- A participant who is known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- A participant who is unwilling or unable to comply with the lifestyle considerations.
- Participant who is a current smoker or an ex-smoker who stopped within 6 months of Screening.
- 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 (for example, type 2 diabetes).
- 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.
- Medication exclusions at screening (Visit 1):
- A participant using any antibiotic medication within 14 days prior to screening or at any time during the study.
- 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).
- Medication exclusions at Baseline (Visit 2):
- A participant who has taken (in the previous 14 days), any antibiotics.
- 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 plaque formation or measures of gingivitis, in the period between Screening and the Baseline visit.
- Periodontal exclusions:
- A participant who shows signs of active periodontitis (with probing pocket depths greater than [>] 3mm).
- 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 Randomized, Controlled, Examiner-Blind Clinical Study Investigating the Effects of a Dentifrice Containing 0.454% w/w Stannous Fluoride on Gingivitis Treatment and Plaque Reduction When Used Twice Daily for 12 Weeks
The purpose of this clinical study is to investigate the efficacy of a dentifrice containing 0.454 percent (%) weight by weight (w/w) stannous fluoride (SnF2), on gingivitis treatment and plaque reduction, compared to a regular fluoride dentifrice after 12 weeks twice daily brushing in a population of clinically diagnosed gingivitis without undergoing dental prophylaxis.
Read the detailed description
This will be a single center, randomized, controlled, single blind (examiner blind), two-treatment arm, parallel study. Study participants will be over 18 years old, non-smokers, in good general health with clinically measurable levels of gingivitis that meet all study criteria at the Screening and Baseline visits. Approximately 160 participants (approximately 80 per group) will be randomized to ensure approximately 144 evaluable participants (approximately 72 per group) complete the study.
- Conditions
- Gingivitis
- Being tested
- Stannous fluoride toothpaste, Sodium fluoride toothpaste
- 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 toothpasteDrug
0.454% w/w SnF2
Sodium fluoride toothpasteDrug
0.243% w/w Sodium fluoride
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | Participants will be instructed to brush their teeth with full ribbon of toothpaste (0.454% w/w SnF2) on head of toothbrush provided for at least one (timed) minute twice a day (morning and evening) for 12 weeks. Receives: Drug: Stannous fluoride toothpaste |
| Negative Control | Active comparator | Participants will be instructed to brush their teeth with full ribbon of toothpaste (0.243% w/w Sodium fluoride) on head of toothbrush provided for at least one (timed) minute twice a day (morning and evening) for 12 weeks. Receives: Drug: Sodium fluoride toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjusted Mean Change From Baseline in the Number of Bleeding Sites (NBS) at Week 12
The NBS were calculated using the bleeding index (BI) assessment. BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth using PCP11.5B Hu-Friedy Qulix Color Coded probe. The probe was gently inserted into the gingival crevice to a depth of approximately 1 millimeter (mm) and then run around the tooth gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. NBS for each participant was calculated as the number of evaluable tooth sites with bleeding observed immediately on probing or within 30 seconds of probing. Change from Baseline was calculated by subtracting the Baseline value from the value at Week 12. Baseline was defined as Day 0. A negative change from Baseline indicated improvement in gingival condition.
Measured: Baseline and Week 12
Secondary outcomes (6)
Adjusted Mean Change From Baseline in the NBS at Week 12 (Test Product Versus [vs.] Reference Product)
The NBS were calculated using the BI assessment. BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth using PCP11.5B Hu-Friedy Qulix Color Coded probe. The probe was gently inserted into the gingival crevice to a depth of approximately 1 mm and then run around the tooth gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. NBS for each participant was calculated as the number of evaluable tooth sites with bleeding observed immediately on probing or within 30 seconds of probing. Change from Baseline was calculated by subtracting the Baseline value from the value at Week 12. Baseline was defined as Day 0. A negative change from Baseline indicated improvement in gingival condition.
Measured: Baseline and Week 12
Adjusted Mean Change From Baseline in the NBS at Week 3 and Week 6 (Test Product vs. Reference Product)
The NBS were calculated using the BI assessment. BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth using PCP11.5B Hu-Friedy Qulix Color Coded probe. The probe was gently inserted into the gingival crevice to a depth of approximately 1 mm and then run around the tooth gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. NBS for each participant was calculated as the number of evaluable tooth sites with bleeding observed immediately on probing or within 30 seconds of probing. Change from Baseline was calculated by subtracting the Baseline value from the value at each indicated timepoint. Baseline was defined as Day 0. A negative change from Baseline indicated improvement in gingival condition.
Measured: Baseline, Week 3 and Week 6
Adjusted Mean Change From Baseline in Mean Overall Turesky Plaque Index (TPI) at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
TPI was used to assess plaque on the facial and lingual surfaces of each scorable tooth. The plaque was first disclosed using a plaque disclosing dye solution, disclosed plaque was then scored on 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 less than one third of the tooth surface; 4=Plaque covering more than one third but less than two thirds of the tooth surface; 5=Plaque covering more than two thirds of the tooth surface. Overall TPI score for each participant=Sum of index values over all evaluable tooth sites (sites scored as 0 to 5), divided by the number of evaluable tooth sites and ranged from 0 to 5. Lower score=better outcome. Change from Baseline=Value at each indicated timepoint minus Baseline value. Baseline=Day 0. A negative change from Baseline indicated improvement (less plaque accumulation).
Measured: Baseline, Weeks 3, 6 and 12
Adjusted Mean Change From Baseline in Mean Interproximal TPI at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
TPI was used to assess plaque on the facial and lingual surfaces of each scorable tooth. The plaque was first disclosed using a plaque disclosing dye solution and scored on 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 less than one third of the tooth surface; 4=Plaque covering more than one third but less than two thirds of the tooth surface; 5=Plaque covering more than two thirds of the tooth surface. Interproximal TPI score for each participant=Sum of index values over all evaluable distal and mesial tooth sites, divided by the number of evaluable distal and mesial tooth sites and ranged from 0 to 5. Lower score=better outcome. Change from Baseline=Value at each indicated timepoint minus Baseline value. Baseline=Day 0. A negative change from Baseline indicated improvement (less plaque accumulation).
Measured: Baseline, Weeks 3, 6 and 12
Adjusted Mean Change From Baseline in BI at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. BI was assessed on the facial and lingual gingival surfaces of each scorable tooth using PCP11.5B Hu-Friedy Qulix Color Coded probe. Gingival bleeding was scored on a 3-points scale with scores ranging from 0 to 2, where 0=No bleeding after 30 seconds, 1=Bleeding observed within 30 seconds of probing, 2=Bleeding observed immediately on probing. BI score for each participant=sum of index values over all evaluable tooth sites (those scored as 0, 1, or 2), divided by the number of evaluable tooth sites. Lower score=better outcome. Change from Baseline was calculated by subtracting the Baseline value from the value at each indicated timepoint. Baseline=Day 0. A negative change from Baseline indicated improvement in gingival condition.
Measured: Baseline, Weeks 3, 6 and 12
Adjusted Mean Change From Baseline in Modified Gingival Index (MGI) at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
MGI assessment is a non-invasive evaluation which focuses on visual symptoms of gingivitis (example, redness, texture, edema). MGI was assessed on facial and lingual surfaces of each scorable tooth and scored on a 5-point scale ranging from 0 to 4, where 0=Absence of inflammation; 1=Mild inflammation; slight change in color, little change in color; little change in texture of any portion of marginal or papillary gingival unit; 2=Mild inflammation; criteria as 1 but involving entire marginal or papillary gingival unit; 3=Moderate inflammation; glazing, redness, edema, and/or hypertrophy of marginal or papillary gingival unit; 4=Severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Lower score indicated better outcome. Change from Baseline=Value at each indicated timepoint minus Baseline [Day 0] value. A negative change from Baseline indicated improvement in symptoms.
Measured: Baseline, Weeks 3, 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start29 Nov 2023
- Primary completion12 Mar 2024
- Study completion12 Mar 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 GingivitisStudies 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
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143670
- Sponsor's protocol ID
- 300107
- Status last verified
- Feb 2025
- First submitted
- 16 Nov 2023
- Last updated
- 21 Mar 2025
- 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 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Examiner-Blind Clinical Study Investigating the Effects of a Dentifrice Containing 0.454% w/w Stannous Fluoride on Gingivitis Treatment and Plaque Reduction When Used Twice Daily for 12 Weeks
- ClinicalTrials.gov ID
- NCT06143670
- Acronym / sponsor ID
- 300107
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 22 Nov 2023 (actual)
- Results
- Posted 21 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical study is to investigate the efficacy of a dentifrice containing 0.454 percent (%) weight by weight (w/w) stannous fluoride (SnF2), on gingivitis treatment and plaque reduction, compared to a regular fluoride dentifrice after 12 weeks twice daily brushing in a population of clinically diagnosed gingivitis without undergoing dental prophylaxis.
Detailed description
This will be a single center, randomized, controlled, single blind (examiner blind), two-treatment arm, parallel study. Study participants will be over 18 years old, non-smokers, in good general health with clinically measurable levels of gingivitis that meet all study criteria at the Screening and Baseline visits. Approximately 160 participants (approximately 80 per group) will be randomized to ensure approximately 144 evaluable participants (approximately 72 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 Product | Experimental | Drug: Stannous fluoride toothpasteParticipants will be instructed to brush their teeth with full ribbon of toothpaste (0.454% w/w SnF2) on head of toothbrush provided for at least one (timed) minute twice a day (morning and evening) for 12 weeks. |
| Negative Control | Active comparator | Drug: Sodium fluoride toothpasteParticipants will be instructed to brush their teeth with full ribbon of toothpaste (0.243% w/w Sodium fluoride) on head of toothbrush provided for at least one (timed) minute twice a day (morning and evening) for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participant 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.
- Participant is of either sex and any gender who, at the time of screening, is at least 18 years old, inclusive.
- A participant who is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant/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.
- Participant oral health that meets all the following:
Key exclusion criteria (40 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 sponsor's 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 a pregnant female (self-reported) or is 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 |
|---|---|---|
| Stannous fluoride toothpaste0.454% w/w SnF2 | Drug | Test Product |
| Sodium fluoride toothpaste0.243% w/w Sodium fluoride | Drug | Negative Control |
Primary outcome
Adjusted Mean Change From Baseline in the Number of Bleeding Sites (NBS) at Week 12
Time frame: Baseline and Week 12
The NBS were calculated using the bleeding index (BI) assessment. BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth using PCP11.5B Hu-Friedy Qulix Color Coded probe. The probe was gently inserted into the gingival crevice to a depth of approximately 1 millimeter (mm) and then run around the tooth gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. NBS for each participant was calculated as the number of evaluable tooth sites with bleeding observed immediately on probing or within 30 seconds of probing. Change from Baseline was calculated by subtracting the Baseline value from the value at Week 12. Baseline was defined as Day 0. A negative change from Baseline indicated improvement in gingival condition.
6 secondary outcomes
Adjusted Mean Change From Baseline in the NBS at Week 12 (Test Product Versus [vs.] Reference Product)
Time frame: Baseline and Week 12
Adjusted Mean Change From Baseline in the NBS at Week 3 and Week 6 (Test Product vs. Reference Product)
Time frame: Baseline, Week 3 and Week 6
Adjusted Mean Change From Baseline in Mean Overall Turesky Plaque Index (TPI) at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
Time frame: Baseline, Weeks 3, 6 and 12
Adjusted Mean Change From Baseline in Mean Interproximal TPI at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
Time frame: Baseline, Weeks 3, 6 and 12
Adjusted Mean Change From Baseline in BI at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
Time frame: Baseline, Weeks 3, 6 and 12
Adjusted Mean Change From Baseline in Modified Gingival Index (MGI) at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
Time frame: Baseline, Weeks 3, 6 and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- 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 Stannous fluoride toothpaste and Sodium fluoride toothpaste in people with 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 13 inclusion and 40 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 21 Mar 2025. 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?
Yes. Results are posted in the registry (first posted 21 Mar 2025). 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 Change From Baseline in the Number of Bleeding Sites (NBS) at Week 12 (time frame: Baseline and Week 12). 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 21 Mar 2025.