Extrinsic Tooth Whitening Evaluation of a Whitening Toothpaste

This single-site, randomized, examiner-blind, two-cell parallel clinical trial enrolled adult subjects with qualifying extrinsic tooth stain. Following baseline assessments, subjects were randomized to either a test whitening dentifrice or a marketed control dentifrice. Subjects brushed twice daily for two minutes with their assigned toothpaste and toothbrush for 42 days. Extrinsic stain on the labial surfaces of the 12 anterior teeth was evaluated at baseline and at Days 7, 14, 28, and 42 using the Macpherson Modification of the Lobene Stain Index, assessing stain intensity, stain area, and total stain scores. Safety was monitored via oral soft and hard tissue examinations and subject-reported sensory assessments. Treatment comparisons were performed using ANCOVA with baseline scores as covariates.

• Whitening Test Dentifrice (Code 826) (Other): Whitening toothpaste used twice daily for two minutes per brushing for six weeks.
• Control dentifrice (Code 378) (Other): Non-whitening toothpaste used twice daily for two minutes per brushing for six weeks.

Primary outcomes

• Change in Extrinsic Tooth Stain (Total Stain Score) [Baseline to Day 42]: Mean change in total extrinsic stain score measured on the labial surfaces of the 12 anterior teeth using the Macpherson Modification of the Lobene Stain Index, combining stain intensity and stain area scores.

Secondary outcomes

• Change in Stain Intensity and Stain Area Scores [Baseline to Days 7, 14, 28, and 42]: Mean changes in stain intensity and stain area scores at each post-baseline time point.

Other outcomes

• Subject-Reported Whitening and Sensory Assessments [Baseline and Days 7, 14, 28, and 42]: Subject-reported perceptions of whitening, mouthfeel, and sensory responses collected via questionnaires.

Sex: All, ages: 18 Years to 65 Years

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

• Annahita Ghassemi, PhD, Study director, Church & Dwight, Inc.