Clinical trial Recruiting at 1 site Interventional Ages 18 to 70

Toothpaste that may reduce plaque and gingivitis in Chinese adults

Official title: A 12-Week, Randomized, Controlled, Examiner-blind, Clinical Study to Evaluate the Plaque Control and Anti-Gingivitis Efficacy of a Toothpaste in Chinese Population

Run by Haleon · NCT07816406 · Data updated 2026-11-12

A toothpaste test will be used to see if it reduces plaque and gingivitis more than a regular fluoride toothpaste in Chinese people with localized gingivitis.

Quick facts

Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment120 (estimated)
SponsorHaleon
Industry-sponsored
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedSeptember 7, 2026
Main results expectedJanuary 2027
Study endsJanuary 2027
Registry record updatedOctober 20, 2026
Trial IDNCT07816406 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with localized plaque-induced gingivitis who can commit to all study visits and procedures.

Probably not a fit

Those without gingivitis or with other oral health conditions may not experience a benefit from the test toothpaste.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, 12-week randomized, examiner-blind study in participants with localized plaque-induced gingivitis. Participants will be assigned to either the test toothpaste or a regular fluoride toothpaste in a parallel-group design with stratification. About 120 individuals will be screened to enroll roughly 108, aiming for 54 per group, to assess gingival health and plaque accumulation. Outcomes focus on changes in gingivitis scores and plaque levels using standard clinical assessments. The study is sponsored by HALEON and conducted at Shanghai Ninth People’s Hospital and affiliated Shanghai Jiao Tong University sources.

Why it matters

Potential benefit: If successful, participants may experience improved gum health and cleaner teeth with the test toothpaste.

How similar studies have gone: Previous studies of similar anti-gingivitis toothpastes have shown potential benefits in reducing plaque and gingival inflammation.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 who is willing and able to comply with scheduled visits, treatment plan, study restrictions, lifestyle considerations 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.
* A participant with localized plaque-induced gingivitis, in the opinion of the clinical examiner or medically qualified designee, as confirmed by visual examination.

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 immediate family.
* A participant who has participated in other studies (including non-medicinal studies) involving study 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 study 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 pregnant (self-reported) or intending to become pregnant over the duration of the study.
* A participant who is breastfeeding.
* A participant with known or suspected intolerance or hypersensitivity to any study materials (or closely related compounds) or any of their stated ingredients.
* A participant unwilling or unable to comply with lifestyle considerations described in this protocol.
* Participants with, in the opinion of the investigator or medically qualified designee, any clinically significant/relevant abnormalities in medical history or oral examination, or any other condition, that would affect the individual's ability to understand and follow study procedures and requirements.
* A participant with any medical condition which, in the opinion of the investigator or medically qualified designee, are causing xerostomia.
* Participants with any medical condition which, in the opinion of the investigator or medically qualified designee, could directly influence gingival bleeding.
* A participant who habitually rinses with water during toothbrushing (self-reported at Screening (Visit 1)).
* Participants with recent history (within the last year) of alcohol or other substance abuse.
* A participant who is a current smoker or an ex-smoker who stopped within 6 months of Screening (self-reported at Screening (Visit 1)).
* A participant who currently uses smokeless forms of tobacco (example \[e.g.\], chewing tobacco, nicotine-based e-cigarettes).
* A participant with oral mucosa disease (e.g., oral lichen planus, oral leukoplakia etc.) or a severe oral condition (e.g., acute necrotizing ulcerative gingivitis or oral or peri-oral ulceration including herpetic lesions) that, in the opinion of the investigator or dentally qualified designee, would compromise study outcomes or the oral health of the Participant /clinical examiner if they were to participate in the study.
* A participant with a tongue or lip piercing, or any other oral feature that, in the opinion of the investigator or dentally qualified designee, could interfere with toothbrush usage or act as a plaque retentive factor.
* A Participant who has previously been enrolled in this study.
* A Participant who has used an anti-bacterial mouthwash (e.g., chlorhexidine) or use of any oral care product within 14 days of Baseline (Visit 2) that, in the opinion of the investigator or dentally qualified designee, could affect plaque formation or gingival health.
* Periodontal Exclusions:

  1. A participant with severe periodontitis or signs of active periodontitis who, in the opinion of the investigator or dentally qualified designee, should not participate in the study.
  2. A participant with gingivitis which, in the opinion of the investigator or dentally qualified designee, would not be expected to respond to treatment with an anti-Gingivitis toothpaste.
  3. A participant who is receiving or has received treatment for periodontal disease (including surgery) within 12 months of Screening.
* Dental Exclusions:

  1. A participant with active caries that, in the opinion of the investigator or dentally qualified designee, could compromise study outcomes or the oral health of the participant if they were to participate in the study.
  2. A participant with a partial or full denture and with an orthodontic appliance (bands, appliances or fixed/ removable retainers).
  3. A Participant who has received orthodontic therapy within 12 months of Screening.
  4. A participant with numerous restorations in a poor state of repair.
  5. A participant with any dental condition (e.g., overcrowding) that, in the opinion of the investigator or dentally qualified designee, could compromise study outcomes or the oral health of the participant if they were to participate in the study.
  6. A participant who has had dental prophylaxis or teeth bleaching within 12 weeks of Screening.
  7. A participant with high levels of extrinsic stain or calculus deposits that, in the opinion of the investigator or dentally qualified designee, could interfere with Baseline (preprophylaxis) plaque assessments.
* A participant currently taking any such medication or oral care product which in opinion of the investigator could affect gingival condition
* A participant who is not eligible for dental prophylaxis based on investigator or medically qualified designee review of their laboratory (blood) test results which includes blood platelet; white blood cell out of normal range; Prothrombin Time (PT) exceeds 15 seconds; Activated Partial Thromboplastin Time (APTT) exceeds 35 seconds; positive HIV test; positive HBV test, Hepatitis B Surface Antigen (HbsAg) and positive syphilis test.
* A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.

Where it's running

  • Shanghai Ninth People's Hospital, Shanghai Jiao Tong Universi-ty School of Medicine
    Shanghai, Shanghai Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.