Dental PlaqueNCT07842042
A Study Investigating Gingival Crevicular Fluid Biomarkers Following Use of a Commercially Available Toothpaste Containing Stannous Fluoride
A study testing Test Toothpaste and Regular Fluoride Toothpaste in people with Dental Plaque and Gingivitis, run by HALEON at 1 site in United Kingdom.
Trial summary
The aim of this study is to evaluate the feasibility, sensitivity, and interpretability of gingival crevicular fluid (GCF) cytokine biomarkers as early indicators of tissue recovery following use of commercial dentifrice compared with a standard fluoride dentifrice in experimental gingivitis model, after 14 days twice… 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 Regular Fluoride Toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Sep 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
- A participant is willing and able to comply with scheduled visits, and other study procedures and restrictions including the lifestyle restrictions.
- A participant is 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.
- A participant with probing pocket depths of less than (<) 3.5mm and a minimum of four teeth from maxillary canine to third molar in both maxillary quadrants that are scorable (including two molars and at least one premolar) at screening.
- A participant has, localized, plaque induced gingivitis at screening, defined as >= 10 and less than equal to (<=) 30% of sites exhibiting bleeding on probing (BOP).
- A participants have a canine, one or two premolars, and two or three molars present in each maxillary quadrant (right and left side).
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 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 is breast feeding, is pregnant (self-reported) or intending to become pregnant over the duration of the study.
- A participant with known or suspected intolerance or hypersensitivity to the 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.
Show all 20Show fewer
- A participant with a recent history (within the last year) of alcohol or other substance abuse.
- Participant who:
- Is taking antibiotics during the study or has taken antibiotics in the two weeks prior to the screening visit.
- Is using or has used an anti-bacterial toothpaste/mouthwash (e.g., chlorhexidine) or another oral care product within 2 weeks of Screening that, in the opinion of the investigator or dentally qualified designee, could affect plaque formation or gingival health.
- Currently taking a systemic medication (e.g., anti-inflammatory, anticoagulant, immunosuppressants) or traditional/ herbal remedy which, in the opinion of the Investigator, could affect plaque/ gingival condition (e.g., ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers).
- Smokes or uses smokeless forms of tobacco (example [e.g.] chewing tobacco, gutkha, pan containing tobacco, e-cigarettes [vapes]).
- Is diagnosed with xerostomia or who the investigator believes might suffer from xerostomia based upon medications or oral examination.
- Has a tongue or lip piercing, or any other oral feature that, in the opinion of the investigator, could interfere with the proper usage of a toothbrush.
- Has, in the opinion of the investigator or medically qualified designee, signs of active periodontal disease or who is receiving or has received treatment for periodontal disease (including surgery) within 12 months of Screening.
- Requires immediate dental intervention to resolve any oral condition.
- Has dentures (partial or full) or has an orthodontic appliance (bands, appliances, or fixed/ removable retainers) that, in the opinion of the investigator, could interfere with the proper usage of a toothbrush.
- A participant who has had teeth bleaching within 12 weeks of Screening.
- 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. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Birmingham
Birmingham, B5 7EG
Praveen Sharma
About this study
Official title: Exploratory Method Development Randomised, Controlled, Double-Blind, Clinical Study Investigating Gingival Crevicular Fluid Biomarkers Following Use of a Commercially Available Toothpaste Containing Stannous Fluoride
The aim of this study is to evaluate the feasibility, sensitivity, and interpretability of gingival crevicular fluid (GCF) cytokine biomarkers as early indicators of tissue recovery following use of commercial dentifrice compared with a standard fluoride dentifrice in experimental gingivitis model, after 14 days twice daily use.
Read the detailed description
This will be a single-center, randomized, controlled, double-blind, split-mouth, 2 treatment arms, parallel group, stratified clinical study in healthy participants with gingivitis and plaque accumulation induced using an experimental gingivitis model, to characterize GCF biomarkers associated with gingival health over time following use of a Test Toothpaste containing stannous fluoride (SnF2) compared to a Regular Fluoride Toothpaste (Reference Toothpaste) on GCF biomarkers. Sufficient participants will be screened to randomize approximately 20 participants (10 per group) to ensure approximately 18 (9 per group) evaluable participants complete the entire study.
- Conditions
- Dental Plaque, Gingivitis
- Being tested
- Test Toothpaste, Regular Fluoride 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 ToothpasteOther
A marketed toothpaste containing 0.454 percent (%) SnF2.
Regular Fluoride ToothpasteOther
A marketed toothpaste containing 0.3152% Weight on Weight (w/w) Sodium Fluoride (NaF).
| Study group | Role | What they receive |
|---|---|---|
| Test Toothpaste | Experimental | Participants will brush their teeth with a full ribbon of Test Toothpaste on the head of the toothbrush thoroughly for at least one (timed) minute twice a day (morning and evening) for 14 days. Receives: Other: Test Toothpaste |
| Reference Toothpaste | Other | Participants will brush their teeth with full ribbon of Reference Toothpaste on the head of the toothbrush thoroughly for at least one (timed) minute twice a day (morning and evening) for 14 days. Receives: Other: Regular Fluoride Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
GCF Biomarkers Profile Assessment at Baseline (Day 0), Day 3, 7, 10 and 14
GCF samples will be collected from the mesio-buccal site of the selected teeth. Proteins will be eluted from the pooled collection papers and then analysed by proximity extension assay.
Measured: Baseline (Day 0) and Day 3, 7, 10 and 14
Secondary outcomes (3)
GCF Volume at Baseline (Day 0), Day 3, 7, 10 and 14
GCF samples will be collected from the mesio-buccal site of the selected teeth. The volume of GCF collected on each strip will be quantified using a Periotron device, which measures the fluid absorbed by the PerioPaper strips and provides an estimate of GCF volume.
Measured: Baseline (Day 0) and Day 3, 7, 10 and 14
Change from Baseline in Modified Gingival Index (MGI) at Day 3, 7, 10 and 14
The MGI assessment is a non-invasive visual evaluation to assess the symptoms of gingivitis. It will be assessed for all evaluable teeth, four sites per test and reference tooth. 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 change in color, little change in texture of any portion of the marginal or papillary gingival unit, 2= Mild inflammation: criteria as (1) but involving the entire marginal or papillary gingival unit, 3= Moderate inflammation: glazing, redness, edema, and/or hypertrophy of the 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. Change from baseline will be calculated by subtracting the Baseline score from the score at the indicated timepoints. Lower score will indicate an improvement in condition.
Measured: Baseline (Day 0) and Day 3, 7, 10 and 14
Change from Baseline in Turesky modification of the Quigley Hein Plaque Index (TPI) at Day 3, 7, 10 and 14
TPI will be used to assess plaque on all gradable test and reference teeth. The plaque will first be disclosed using a plaque disclosing dye solution. 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 more than equal to (>=) 1/3 but < 2/3 of the tooth surface, 5= Plaque covering >= 2/3 of the tooth surface. Change from baseline will be calculated by subtracting the Baseline score from the score at the indicated timepoints. Lower score will indicate improvement in gingival health.
Measured: Baseline (Day 0) and Day 3, 7, 10 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start28 Sep 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Praveen Sharma, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842042
- Sponsor's protocol ID
- 400370
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2026
- Last updated
- 9 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Method Development Randomised, Controlled, Double-Blind, Clinical Study Investigating Gingival Crevicular Fluid Biomarkers Following Use of a Commercially Available Toothpaste Containing Stannous Fluoride
- ClinicalTrials.gov ID
- NCT07842042
- Acronym / sponsor ID
- 400370
- Conditions
- Dental Plaque, Gingivitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 25 Sep 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 is to evaluate the feasibility, sensitivity, and interpretability of gingival crevicular fluid (GCF) cytokine biomarkers as early indicators of tissue recovery following use of commercial dentifrice compared with a standard fluoride dentifrice in experimental gingivitis model, after 14 days twice daily use.
Detailed description
This will be a single-center, randomized, controlled, double-blind, split-mouth, 2 treatment arms, parallel group, stratified clinical study in healthy participants with gingivitis and plaque accumulation induced using an experimental gingivitis model, to characterize GCF biomarkers associated with gingival health over time following use of a Test Toothpaste containing stannous fluoride (SnF2) compared to a Regular Fluoride Toothpaste (Reference Toothpaste) on GCF biomarkers. Sufficient participants will be screened to randomize approximately 20 participants (10 per group) to ensure approximately 18 (9 per group) evaluable participants complete the entire study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Toothpaste | Experimental | Other: Test ToothpasteParticipants will brush their teeth with a full ribbon of Test Toothpaste on the head of the toothbrush thoroughly for at least one (timed) minute twice a day (morning and evening) for 14 days. |
| Reference Toothpaste | Other | Other: Regular Fluoride ToothpasteParticipants will brush their teeth with full ribbon of Reference Toothpaste on the head of the toothbrush thoroughly for at least one (timed) minute twice a day (morning and evening) for 14 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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.
- A participant is willing and able to comply with scheduled visits, and other study procedures and restrictions including the lifestyle restrictions.
- A participant is 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.
- A participant with probing pocket depths of less than (<) 3.5mm and a minimum of four teeth from maxillary canine to third molar in both maxillary quadrants that are scorable (including two molars and at least one premolar) at screening.
- A participant has, localized, plaque induced gingivitis at screening, defined as >= 10 and less than equal to (<=) 30% of sites exhibiting bleeding on probing (BOP).
Key exclusion criteria (20 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 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 is breast feeding, is pregnant (self-reported) or intending to become pregnant over the duration of the study.
- A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
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 ToothpasteA marketed toothpaste containing 0.454 percent (%) SnF2. | Other | Test Toothpaste |
| Regular Fluoride ToothpasteA marketed toothpaste containing 0.3152% Weight on Weight (w/w) Sodium Fluoride (NaF). | Other | Reference Toothpaste |
Primary outcome
GCF Biomarkers Profile Assessment at Baseline (Day 0), Day 3, 7, 10 and 14
Time frame: Baseline (Day 0) and Day 3, 7, 10 and 14
GCF samples will be collected from the mesio-buccal site of the selected teeth. Proteins will be eluted from the pooled collection papers and then analysed by proximity extension assay.
3 secondary outcomes
GCF Volume at Baseline (Day 0), Day 3, 7, 10 and 14
Time frame: Baseline (Day 0) and Day 3, 7, 10 and 14
Change from Baseline in Modified Gingival Index (MGI) at Day 3, 7, 10 and 14
Time frame: Baseline (Day 0) and Day 3, 7, 10 and 14
Change from Baseline in Turesky modification of the Quigley Hein Plaque Index (TPI) at Day 3, 7, 10 and 14
Time frame: Baseline (Day 0) and Day 3, 7, 10 and 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 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.
Praveen Sharma principal investigator
University of Birmingham
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 Regular Fluoride 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 6 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 9 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haleon Response Center (+441932 95 95 00, ww.clinical-trial-register@haleon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GCF Biomarkers Profile Assessment at Baseline (Day 0), Day 3, 7, 10 and 14 (time frame: Baseline (Day 0) and Day 3, 7, 10 and 14). 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 9 Oct 2026.