Clinical Study to Investigate the Tooth Stain Removal Efficacy of Two Experimental Toothpastes Co… (NCT05459558) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study to Investigate the Tooth Stain Removal Efficacy of Two Experimental Toothpastes Compared to a Standard Toothpaste When Used Twice Daily for 8 Weeks
United States280 participantsStarted 2022-09-15
Plain-language summary
The aim of this study is to investigate the stain removal efficacy of 2 experimental anti-dentin hypersensitivity (DH) dentifrices with four and eight weeks twice daily use. A daily use, regular fluoride dentifrice will be included as a reference dentifrice.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. At least 16 natural (vital) teeth including 11 of the 12 anterior teeth.
✓. Facial surfaces of all anterior teeth (maxillary and mandibular) and lingual surfaces of anterior teeth (mandibular only) gradable for MLSI with no significant calculus or large restorations as judged by the clinical examiner.
✓. Presence of extrinsic dental stain (formed on the surface of the teeth) as determined from a gross visual examination which, in the opinion of the clinical examiner, originates from the diet and/or use of tobacco products.
✓. Facial surfaces of central and lateral maxillary incisors gradable for tooth shade (free of cervical margin defects and restorations which could impact assessment), as judged by the clinical examiner.
✓. Baseline Total MLSI (Area x Intensity) greater than or equal to (\>=)15 for the facial surfaces of the 12 anterior teeth.
✓. Baseline mean tooth shade (VITA Bleachedguide 3D-MASTER) \>=11 on the facial surfaces of the 4 maxillary incisors.
Exclusion criteria
✕. currently daily use of mouthwashes containing ingredients known to cause tooth stain (for example, chlorhexidine or cetylpyridinium chloride),
✕. past or current use of minocycline,
✕. use of tetracycline or doxycycline within 30 days of screening and/or during the study,
✕. medications known to cause tooth stain (for example, drugs or supplements containing metal ions known to increase enamel staining).
What they're measuring
1
Change From Baseline in Mean Total Modified Lobene Stain Index (MLSI) Score at Week 8