NCT06292611

Two Week Cumulative Extrinsic Stain Removal of a Battery-powered Toothbrush and a Manual Toothbrush

Clinical Evaluation of a Powered Toothbrush in Tooth Whitening Via Extrinsic Stain Removal

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Church & Dwight Company, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To evaluate and compare the extrinsic stain removal efficacy of a battery-powered toothbrush and a manual toothbrush following two weeks of brushing.

Detailed description

This is a two week, examiner blinded, randomized, parallel group, IRB-approved research study evaluating the extrinsic stain removal efficacy of a new battery-operated toothbrush and a marketed manual toothbrush. This study will accept up to 110 subjects, 18-65 years of age, in anticipation that 50 subjects per treatment group will complete the study. Qualified subjects with sufficient extrinsic stain, according to Macpherson Modified Lobene Stain Index (MLSI) will be randomly assigned to one of two treatment groups. Subjects will brush with the assigned toothbrush and toothpaste provided for timed brushing twice a day for two weeks.

Conditions

• Dental Devices, Home Care

Interventions

Type	Name	Description
DEVICE	Battery operated toothbrush	Device on extrinsic stain removal efficacy
DEVICE	Manual toothbrush	Device on extrinsic stain removal efficacy

Timeline

• Start date: 2023-11-27
• Primary completion: 2023-12-12
• Completion: 2024-01-25
• First posted: 2024-03-05
• Last updated: 2024-03-05

Locations

1 site across 1 country: United States