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NCT07842978
Clinical Study Examining the Control of Plaque and Gingivitis
Conditions: Gingivitis
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: Yes
Phase: PHASE3
Enrollment: 135
Sponsor: Colgate Palmolive
Location: West China Dental Institute of Chengdu Chengdu Sichuan
Summary
The objective of this six-month clinical investigation is to evaluate the efficacy of a silica-free meridol toothpaste versus Colgate Cavity Protection Toothpaste in the control of established dental plaque and gingivitis.
Eligibility Criteria
Inclusion Criteria:
* Subjects, ages 18-70, inclusive.
* Availability for the six-month duration of the clinical research study.
* Good general health.
* Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
* Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
* Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
* Signed Informed Consent Form
Exclusion Criteria:
* Presence of orthodontic bands.
* Presence of partial removable dentures.
* Tumor(s) of the soft or hard tissues of the oral cavity.
* Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
* Five or more carious lesions requiring immediate restorative treatment.
* Antibiotic use any time during the one month prior to entry into the study.
* Participation in any other clinical study or test panel within the one month prior to entry into the study.
* Dental prophylaxis during the past two weeks prior to baseline examinations.
* History of allergies to oral care/personal care consumer products or their ingredients.
* On any prescription medicines that might interfere with the study outcome.
* An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
Source: ClinicalTrials.gov (NCT07842978). StuddyBuddy aggregates publicly available trial information.