A Six-month Clinical Investigation of a Silica-free Meridol Toothpaste Versus Colgate Cavity Protection Toothpaste for the Control of Established Dental Plaque and Gingivitis
| Registry | NCT07842978 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 135 (Estimated) |
| Sponsor | Colgate Palmolive (Industry) |
| Conditions | Gingivitis |
| Interventions | Silica Free Meridol, Meridol, Colgate Dental Product (Drug) |
| Dates | start 2026-10-01 (estimated), primary completion 2027-04-01 (estimated), completion 2027-04-01 (estimated), first posted 2026-09-25, last updated 2026-09-25 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Gingivitis All trials of Silica Free Meridol All trials of Meridol
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Test 1 toothpaste | Experimental | Drug: Silica Free Meridol | Subjects will be instructed to brush their teeth with the assigned teeth dentifrice and toothbrush twice daily. |
| Test 2 toothpaste | Active comparator | Drug: Meridol | Subjects will be instructed to brush their teeth with the assigned teeth dentifrice and toothbrush twice daily. |
| Test 3 toothpaste | Active comparator | Drug: Colgate Dental Product | Subjects will be instructed to brush their teeth with the assigned teeth dentifrice and toothbrush twice daily. |
Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| West China Dental Institute of Chengdu | Chengdu, Sichuan | China |