NCT07428603

Extrinsic Tooth Whitening Evaluation of a Whitening Toothpaste

Six-Week Clinical Evaluation of a Toothpaste in Tooth Whitening Via Extrinsic Stain Removal

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Church & Dwight Company, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Stain Removal Efficacy

Interventions

Type	Name	Description
OTHER	Whitening Test Dentifrice (Code 826)	Whitening toothpaste used twice daily for two minutes per brushing for six weeks.
OTHER	Control dentifrice (Code 378)	Non-whitening toothpaste used twice daily for two minutes per brushing for six weeks.

Timeline

• Start date: 2024-08-08
• Primary completion: 2024-09-20
• Completion: 2024-09-20
• First posted: 2026-02-24
• Last updated: 2026-02-24

Locations

1 site across 1 country: United States