Clinical Research Study to Evaluate the Stain Removal Efficacy (NCT06242769) | Clinical Trial Compass
CompletedPhase 3
Clinical Research Study to Evaluate the Stain Removal Efficacy
Puerto Rico80 participantsStarted 2020-07-27
Plain-language summary
The objective of this clinical research study is to evaluate the stain removal efficacy of a toothpaste containing stannous fluoride as compared to negative control toothpaste in adults.
Who can participate
Age range21 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:
* Signed Informed Consent Form
* Good general health
* Male and female subjects, aged 21-70, inclusive
* Present 12 scoreable natural anterior teeth
* A minimum mean Composite Lobene Index score of 1 or greater
* Available for the duration of the study
* Clinical evidence of a tendency to form extrinsic stain on anterior teeth
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
* Use of antibiotics or stain inducing medications 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
* Self-reported pregnancy and/or women who are breast feeding
* Dental prophylaxis received in the past four weeks prior to baseline examinations
* History of allergies to oral care/personal care consumer products or their ingredients, including allergies to hydrogen peroxide
* On any prescription medicines that might interfere with the study outcome
* History of alcohol and/or drug abuse
* Exposed to a tooth whitening procedure during the last 3 months
What they're measuring
1
Composite Lobene Stain Index
Timeframe: measurement at baseline, 3 week & 6 week