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Completed
NCT07870018
Clinical Research Study to Evaluate Stain Removal and Whitening Improvement
Conditions: Tooth Whitening, Tooth Discoloration
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: Yes
Phase: PHASE2
Enrollment: 75
Sponsor: Colgate Palmolive
Location: Consumer Research Consulting, LLC Melbourne Florida
Summary
The objective of this clinical research study is to evaluate the stain removal and whitening improvement of a toothpaste containing Vitamin C and 1100 ppm F as sodium fluoride as compared to a matching placebo toothpaste (identically formulated without Vitamin C ) in adults
Eligibility Criteria
Inclusion Criteria:
* Signed Informed Consent Form;
* Male and female subjects, aged 18-70, inclusive;
* Good general health and good oral health based on the opinion of the study investigator;
* Presence of all permanent natural anterior teeth (no veneers /crowns /restorations that may interfere with this study scoring procedures );
* A minimum mean of 1 .5 ≥ determined by the Interproximal Modified Lobene (IML ) Stain Index;
* Minimum average VITA 3D-Master Extended Bleachedguide shade score of 17 ≥ or darker;
* Available for the duration of the study;
* Clinical evidence of a tendency to form extrinsic stain on anterior teeth
Exclusion Criteria:
* Presence of orthodontic appliances /retainers involving scorable teeth;
* Presence of partial removable /fixed dentures and /or restorations involving scorable teeth;
* Tumor (s ) of the soft or hard tissues of the oral cavity;
* Obvious signs of periodontal disease rampant caries, or any condition that the dental examiner considers exclusionary from the study;
* Five or more carious lesions requiring immediate care;
* Use of antibiotics, stain-inducing medications, and /or on any prescription that might interfere with the study outcome;
* Concurrent participation in another clinical study;
* Self-reported pregnancy and /or lactating women;
* Have used professional whitening product within one (1 ) year or had a dental prophylaxis (professional dental cleaning ) within thirty (30 ) days - prior to the start of the study;
* History of allergies to oral care /personal care consumer products or their ingredients;
* History of alcohol and /or drug abuse.
Source: ClinicalTrials.gov (NCT07870018). StuddyBuddy aggregates publicly available trial information.