Efficacy of a Toothpaste in Reducing Plaque, Gingivitis, and Gingival Bleeding (NCT07499115) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Efficacy of a Toothpaste in Reducing Plaque, Gingivitis, and Gingival Bleeding
China90 participantsStarted 2026-04
Plain-language summary
To assess the efficacy of a toothpaste containing chitosan in reducing plaque, gingivitis, and gingival bleeding, compared with Colgate Cavity Protection Toothpaste
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female, aged 18-70 years (inclusive).
* Available for the duration of the study.
* Able to understand and willing to read and sign the Informed Consent Form after the nature of the study has been fully explained.
* Willing to comply with all study procedures and clinical examination schedules.
* Good general health (absence of any condition that, in the opinion of the study examiner, might pose risk during participation; e.g., certain heart conditions, valve/hip replacements).
* Presence of at least 20 natural teeth (excluding third molars) with scorable facial and lingual surfaces.
* Mean Modified Gingival Index (MGI, Lobene) ≥ 2.0 and Mean Modified Plaque Index (MPI, Turesky) ≥ 1.5 at screening.
* Willing and able to complete study questionnaires on product usage experience during routine toothbrushing.
Exclusion Criteria:
* Pregnant or lactating.
* Use of tobacco products.
* History of alcohol or drug abuse.
* Any medical condition (e.g., significant heart or liver disease, bleeding disorders, blood dyscrasias) or current medication use that, in the investigator's judgment, may compromise subject safety or the quality of study results.
* Medical condition requiring pre-medication prior to dental visits/procedures.
* History of allergy to oral hygiene products.
* Use of anti-inflammatory, immunosuppressive, antimicrobial, or anticoagulant drugs, or antibiotics within 30 days prior to study start or during the study.
* Ongoing use of medicati…