A Randomized, Single-center, Two-cell, Double-blind and Parallel-group Design Clinical Study Conducted in the Bangkok, Thailand Area, to Investigate the Clinical Efficacy of a Test Toothpaste Containing 0.454% Stannous Fluoride as Compared to a Regular Fluoride Toothpaste Containing 0.76% Sodium Monofluorophosphate in Controlling Supragingival Calculus Formation Over a 12-week Period.
| Registry | NCT07223060 |
|---|---|
| Status | Completed |
| Phase | Phase 2 / Phase 3 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 100 (Actual) |
| Sponsor | Colgate Palmolive (Industry) |
| Conditions | Calculus, Dental |
| Interventions | 0.454% stannous fluoride, 0.76% sodium monofluorophosphate (Drug) |
| Dates | start 2017-05-17, primary completion 2017-10-06, completion 2017-10-06, first posted 2025-10-31, last updated 2025-12-11 |
| Locations | 1 site in Thailand |
Related Papers Related Patents Related Grants Related Experts
All trials for Calculus, Dental All trials of 0.454% stannous fluoride All trials of 0.76% sodium monofluorophosphate
To evaluate the comparative clinical efficacy of a test toothpaste containing 0.454% stannous fluoride as compared to a regular fluoride toothpaste containing 0.76% sodium monofluorophosphate in controlling supragingival calculus formation over a 12-week period.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Test 1 toothpaste | Experimental | Drug: 0.454% stannous fluoride | |
| Test 2 toothpaste | Active comparator | Drug: 0.76% sodium monofluorophosphate |
Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers
Inclusion Criteria: * Subjects were required to sign an Informed Consent form * Subjects had to be in general good health * Male and female adults between the ages of 18-70 (inclusive) * Six (6) scoreable mandibular anterior teeth free of large restorations or dental prosthetic crowns * Subjects were required to possess a Volpe-Manhold Calculus Index of at least 7.0 * Subjects had to be able to participate for the full duration (20 weeks) of the study Exclusion Criteria: * Presence of orthodontic appliances or removable prosthesis at the lower jaw or more than one mandibular anterior tooth with a prosthetic crown or veneer * Tumor(s) or significant pathology of the soft or hard tissues of the oral cavity * Moderate or advanced periodontal disease * Five or more carious lesions requiring immediate care * Use of antibiotics or steroids any time during one month prior to entry into the study * Participation in any other clinical study or panel test * Pregnant or breast feeding women * History of allergies to dentifrice and personal care ingredients * Allergies to dentifrice products * Medical reasons that prohibit eating or drinking for 4 hours prior to clinical facility visit.
| Facility | City | Country | Status |
|---|---|---|---|
| M U International Oral Science Research, Ltd. | Bangkok, Bangkok | Thailand |