A Study to Evaluate the Effect of a Test (Sodium Bicarbonate) Toothpaste on the Oral Microbiome (NCT07273539) | Clinical Trial Compass
CompletedNot Applicable
A Study to Evaluate the Effect of a Test (Sodium Bicarbonate) Toothpaste on the Oral Microbiome
United Kingdom74 participantsStarted 2025-10-27
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 immedia…
What they're measuring
1
Change From Baseline in Bacterial Composition at Week 12 by Treatment Groups