CompletedNot Applicable

Extrinsic Tooth Whitening Evaluation of a Whitening Toothpaste

United States118 participantsStarted 2024-08-08

Plain-language summary

This randomized, examiner-blind, parallel-group clinical study evaluated the effectiveness of a whitening toothpaste compared with a control toothpaste in removing extrinsic tooth stain over six weeks of twice-daily unsupervised use. Adult subjects were assessed at baseline and after 7, 14, 28, and 42 days of product use using the Macpherson Modification of the Lobene Stain Index. Oral soft and hard tissues and subject-reported sensory responses were also evaluated throughout the study.

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: * Adults 18-65 years in good general health * Mean MLSI score ≥1.5 on labial surfaces of at least 8 of 12 anterior teeth * Adequate oral hygiene and willingness to comply with study requirements * Dental prophylaxis within past 18 months but not within past 3 months * Willing to refrain from other whitening or oral care products during the study Exclusion Criteria: * Significant medical conditions or oral pathology affecting assessments * History of adverse reactions to oral hygiene products * Orthodontic appliances or restorations interfering with stain assessment * Moderate or advanced periodontitis * Recent bleaching or whitening treatments * Pregnant or nursing

What they're measuring

Change in Extrinsic Tooth Stain (Total Stain Score)

Timeframe: Baseline to Day 42

Trial details

NCT IDNCT07428603

SponsorChurch & Dwight Company, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09-20

View on ClinicalTrials.gov More Stain Removal Efficacy trials