A Study to Evaluate the Effect of a Test (Sodium Bicarbonate) Toothpaste on the Oral Microbiome

NCT07273539 | Completed

• 1 other identifier: 400039
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Bacterial Composition at Week 12 by Treatment Groups

  Taxonomic changes of microbial communities in plaque samples will be reported.

  Baseline and Week 12

Secondary Outcomes (3)

• Change From Baseline in Potential Bacterial Activity at Week 12 by Treatment Groups

  Baseline and Week 12

• Differences in Bacterial Composition at Week 12 (Test Toothpaste Versus (Vs) Control Toothpaste)

  Week 12

• Differences in Bacterial Composition Between Different Areas of Plaque at Week 12

  Week 12

Study Arms (2)

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.

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.

Drug: Sodium Fluoride Toothpaste

Interventions

Sodium Bicarbonate Toothpaste DRUG

A toothpaste containing sodium bicarbonate and sodium fluoride.

Test Toothpaste

Sodium Fluoride Toothpaste DRUG

A toothpaste containing 0.315 percent (%) weight/weight (w/w) sodium fluoride; 1450 parts per million (ppm) fluoride.

Reference Toothpaste

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

University of Birmingham

Birmingham, B5 7EG, United Kingdom

Location

MeSH Terms

Conditions

Gingivitis

Interventions

sodium bicarbonate-based toothpaste

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Praveen Sharma

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 9, 2025
• Study Start: October 27, 2025
• Primary Completion: February 27, 2026
• Study Completion: February 27, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.

Locations

GB (1)