Clinical Study to Assess the Efficacy of Professional Tooth Whitening Maintenance System (NCT06613347) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study to Assess the Efficacy of Professional Tooth Whitening Maintenance System
United States93 participantsStarted 2024-10-07
Plain-language summary
Clinical study to assess the efficacy of professional tooth whitening maintenance system of a Colgate toothpaste containing 5% Hydrogen Peroxide with a stain-fighter mouthwash as compared to only the stainfighter mouthwash and a negative control toothpaste
Who can participate
Age range18 Years – 65 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:
* permanent natural teeth (6-11) (22-27)
* composite lobene =\>1
* Signed Informed Consent Form
* Male and female subjects aged 18-70 years, inclusive
* Good general health and good oral health based on the opinion of the study investigator
* All maxillary anterior teeth (teeth #6 through #11) must be present;\& mandibular anterior ( Teeth #22 through 27) must be present
* Availability for the duration of the study
* Minimum average Vita Extended Bleachedguide 3D-Master shade score of 17 ≥ or darker
* A minimum mean of 1.5 ≥ determined by the Interproximal Modified Lobene (IML) Stain Index
* Demonstrate a tendency to form stain in anterior teeth/ Have high staining habits ( coffee/ wine/ tea drinker)
Exclusion Criteria:
* allergies
* Presence of orthodontic appliances or any anterior tooth with a prosthetic crown or veneer
* Restorations on the tooth to be scored which may interfere with scoring procedures
* 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
* Concurrent participation in another clinical study
* Self-reported pregnant and/or lactating women
* History of allergies to tooth whitening products, hydrogen peroxide, personal care consumer products, or their ingredients
* Have dentinal sensitivity
* Taking medication within a year which could alters natural tooth color or appearance,
* Have used Professiona…