The Study to Evaluate the Plaque Control and Anti-Gingivitis Efficacy of a Toothpaste in Chinese Population

NCT07816406 | Not Yet Recruiting

• 1 other identifier: 400317
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the efficacy of the test toothpaste compared to a regular fluoride toothpaste in the reducing gingivitis and plaque accumulation in Chinese participants with plaque-induced gingivitis.

Conditions

Dental Plaque; Gingivitis

Outcome Measures

Primary Outcomes (1)

• Mean Bleeding Index (Bl) at Week 12

  Gingival bleeding will be assessed as an invasive assessment of BI. It will be assessed for all evaluable surfaces of the facial and lingual/palatal gingiva with six sites per tooth. To perform the bleeding assessment, a round-ended probe will be inserted approximately 1 millimeter (mm) into the gingival sulcus at approximately 60 degrees and will be moved from the distal interproximal area to the mesial interproximal area. Presence/ absence of gingival bleeding will be assessed for 30 seconds after probing and will be scored on a 3-points scale ranging from 0 to 2, where 0 equal to (=) no bleeding after 30 seconds; 1= bleeding observed within 30 seconds of probing; 2= bleeding observed immediately on probing. Lower score will indicate an improvement in the symptoms.

  At Week 12

Secondary Outcomes (5)

• Mean BI At Week 2 and 6

  At Week 2 and 6

• Mean Number of Bleeding Site (NBS) At Week 2, 6 and 12

  At Week 2, 6 and 12

• Mean Overall Turesky Modification of the Quigley Hein Index (TPI) At Week 2, 6 and 12

  At Week 2, 6 and 12

• Mean Interproximal TPI At Week 2, 6 and 12

  At Week 2, 6 and 12

• Mean Modified Gingival Index (MGI) At Week 2, 6 and 12

  At Week 2, 6 and 12

Study Arms (2)

Test Toothpaste

EXPERIMENTAL

Participants will brush their teeth with a ribbon of Test Toothpaste across the full brush head for at least one timed minute twice a day (morning and evening) for 12 Weeks.

Other: Test Toothpaste

Control Toothpaste (Regular Fluoride Toothpaste)

OTHER

Participants will brush their teeth with a ribbon of Control Toothpaste across the full brush head for at least one timed minute twice a day (morning and evening) for 12 Weeks.

Other: Regular Fluoride Toothpaste

Interventions

Test Toothpaste OTHER

A toothpaste containing Isopropyl Methyl Phenol (IPMP).

Test Toothpaste

Regular Fluoride Toothpaste OTHER

A regular sodium fluoride toothpaste containing 1450 parts per million (ppm).

Control Toothpaste (Regular Fluoride Toothpaste)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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 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.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

Shanghai Ninth People's Hospital, Shanghai Jiao Tong Universi-ty School of Medicine

Shanghai, Shanghai Municipality, 200011, China

Location

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Central Study Contacts

Haleon Response Center

CONTACT

+441932 95 95 00; ww.clinical-trial-register@haleon.com

Study Design

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

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 11, 2026

Record last verified: 2026-09

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

CN (1)