GingivitisNCT07273539
A Study to Evaluate the Effect of a Test (Sodium Bicarbonate) Toothpaste on the Oral Microbiome
A study testing Sodium Bicarbonate Toothpaste and Sodium Fluoride Toothpaste in people with Gingivitis, run by HALEON at 1 site in United Kingdom.
Trial summary
The aim of this 12-week clinical study is to evaluate the effect of a toothpaste containing sodium bicarbonate over time on the oral microbiome and to explore its effect in comparison to a regular fluoride toothpaste in participants with localized gingivitis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Sodium Bicarbonate Toothpaste and Sodium Fluoride Toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Oct 2025to 27 Feb 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 to 65 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.
- Participant's biological sex at birth was male or female.
- Participant who, at the time of screening is aged 18-65 years, 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 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 with at least 20 natural, permanent teeth (excluding 3rd molars) and with at least 40 evaluable surfaces.
- A healthy participant with mild to moderate gingivitis in the opinion of the clinical examiner.
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 has any other clinical serious or unstable conditions (example, cardiovascular diseases, diabetes, liver disorders, and kidney disorders) which could have affected study out comes and/or participant safety.
- A participant who is a pregnant female (self-reported) at screening or baseline visit or intending to become pregnant over the duration of the study or 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.
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- A participant unwilling or unable to comply with the Lifestyle Considerations described in this protocol (these will be added in the full 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 (example, chewing tobacco, gutkha, pan containing tobacco, nicotine-based e-cigarettes).
- A participant who is diagnosed with oral dryness or is taking any medication that in the view of the investigator is causing oral dryness.
- 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 (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.
- A participant using any antibiotic and/or probiotic medication within 28 days prior to screening or at any time during the study.
- Participant who has used an oral care product containing anti-bacterial (example, chlorhexidine), probiotic or other ingredient that, in the opinion of the investigator or dentally qualified designee, could affect plaque formation or gingival health within 4 weeks of Screening or between Screening and the Baseline visit.
- A participant currently taking an anti-inflammatory medication which, in the opinion of the Investigator, could affect gingival condition.
- 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 (example, anti-inflammatory, anticoagulant, immunosuppressants) or traditional/herbal remedy which, in the opinion of the Investigator, could affect plaque/ gingival condition (example, ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers).
- A participant who shows signs of periodontitis or 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.
- 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 (example, 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 (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
- 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 Randomised, Controlled, Examiner Blind Study to Evaluate the Effect of a Sodium Bicarbonate Toothpaste on the Oral Microbiome
The aim of this 12-week clinical study is to evaluate the effect of a toothpaste containing sodium bicarbonate over time on the oral microbiome and to explore its effect in comparison to a regular fluoride toothpaste in participants with localized gingivitis.
Read the detailed description
This will be a single-center, 12-week, randomized, controlled, single-blind (examiner only), two-treatment arm, parallel group design, clinical study investigating the effect of a toothpaste containing sodium bicarbonate on the oral microbiome in healthy adult participants with mild-moderate gingivitis. Approximately 55 participants (approximately 27 per group) will be randomized to ensure approximately 50 evaluable participants (approximately 25 per group) complete the study.
- Conditions
- Gingivitis
- Being tested
- Sodium Bicarbonate 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.
Sodium Bicarbonate ToothpasteDrug
A toothpaste containing sodium bicarbonate and sodium fluoride.
Sodium Fluoride ToothpasteDrug
A toothpaste containing 0.315 percent (%) weight/weight (w/w) sodium fluoride; 1450 parts per million (ppm) fluoride.
| Study group | Role | What they receive |
|---|---|---|
| Test Toothpaste | Experimental | Participants will be instructed to brush their teeth with the test toothpaste for at least one minute twice daily (morning and evening) for 12 weeks. Receives: Drug: Sodium Bicarbonate Toothpaste |
| Reference Toothpaste | Active comparator | Participants will be instructed to brush their teeth with the reference toothpaste for at least one minute twice daily (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.
Change From Baseline in Bacterial Composition at Week 12 by Treatment Groups
Taxonomic changes of microbial communities in plaque samples will be reported.
Measured: Baseline and Week 12
Secondary outcomes (3)
Change From Baseline in Potential Bacterial Activity at Week 12 by Treatment Groups
Potential functional capabilities of microbial communities in plaque samples will be reported in different areas of plaque.
Measured: Baseline and Week 12
Differences in Bacterial Composition at Week 12 (Test Toothpaste Versus (Vs) Control Toothpaste)
Comparison of bacterial composition in different areas of plaque will be reported.
Measured: Week 12
Differences in Bacterial Composition Between Different Areas of Plaque at Week 12
Comparison of bacterial composition in different areas of plaque will be reported for test and reference toothpaste.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start27 Oct 2025
- Primary completion27 Feb 2026
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 74 participants (actual)
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
- NCT07273539
- Sponsor's protocol ID
- 400039
- Status last verified
- Mar 2026
- First submitted
- 27 Nov 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- 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 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled, Examiner Blind Study to Evaluate the Effect of a Sodium Bicarbonate Toothpaste on the Oral Microbiome
- ClinicalTrials.gov ID
- NCT07273539
- Acronym / sponsor ID
- 400039
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 9 Dec 2025 (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 12-week clinical study is to evaluate the effect of a toothpaste containing sodium bicarbonate over time on the oral microbiome and to explore its effect in comparison to a regular fluoride toothpaste in participants with localized gingivitis.
Detailed description
This will be a single-center, 12-week, randomized, controlled, single-blind (examiner only), two-treatment arm, parallel group design, clinical study investigating the effect of a toothpaste containing sodium bicarbonate on the oral microbiome in healthy adult participants with mild-moderate gingivitis. Approximately 55 participants (approximately 27 per group) will be randomized to ensure approximately 50 evaluable participants (approximately 25 per group) complete the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Toothpaste | Experimental | Drug: Sodium Bicarbonate ToothpasteParticipants will be instructed to brush their teeth with the test toothpaste for at least one minute twice daily (morning and evening) for 12 weeks. |
| Reference Toothpaste | Active comparator | Drug: Sodium Fluoride ToothpasteParticipants will be instructed to brush their teeth with the reference toothpaste for at least one minute twice daily (morning and evening) for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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's biological sex at birth was male or female.
- Participant who, at the time of screening is aged 18-65 years, 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 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 (33 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 has any other clinical serious or unstable conditions (example, cardiovascular diseases, diabetes, liver disorders, and kidney disorders) which could have affected study out comes and/or participant safety.
- A participant who is a pregnant female (self-reported) at screening or baseline visit or intending to become pregnant over the duration of the study or 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 |
|---|---|---|
| Sodium Bicarbonate ToothpasteA toothpaste containing sodium bicarbonate and sodium fluoride. | Drug | Test Toothpaste |
| Sodium Fluoride ToothpasteA toothpaste containing 0.315 percent (%) weight/weight (w/w) sodium fluoride; 1450 parts per million (ppm) fluoride. | Drug | Reference Toothpaste |
Primary outcome
Change From Baseline in Bacterial Composition at Week 12 by Treatment Groups
Time frame: Baseline and Week 12
Taxonomic changes of microbial communities in plaque samples will be reported.
3 secondary outcomes
Change From Baseline in Potential Bacterial Activity at Week 12 by Treatment Groups
Time frame: Baseline and Week 12
Differences in Bacterial Composition at Week 12 (Test Toothpaste Versus (Vs) Control Toothpaste)
Time frame: Week 12
Differences in Bacterial Composition Between Different Areas of Plaque at Week 12
Time frame: Week 12
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 11 Mar 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.
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 Sodium Bicarbonate Toothpaste and Sodium Fluoride Toothpaste in people with 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 7 inclusion and 33 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 11 Mar 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?
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 Bacterial Composition at Week 12 by Treatment Groups (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 11 Mar 2026.