Extrinsic Tooth Whitening Evaluation of a Whitening Toothpaste

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

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.

Study Overview

• Status: Completed
• Conditions: Stain Removal Efficacy
• Intervention / Treatment: Other: Whitening Test Dentifrice (Code 826); Other: Control dentifrice (Code 378)

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.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Salus Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Toothpaste; Investigational whitening toothpaste evaluated for removal of extrinsic tooth stain over 42 days of use.	Other: Whitening Test Dentifrice (Code 826); Whitening toothpaste used twice daily for two minutes per brushing for six weeks.
Other: Sodium Fluoride Control Dentifrice; Non-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Extrinsic Tooth Stain (Total Stain Score)	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.	Baseline to Day 42

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Stain Intensity and Stain Area Scores	Mean changes in stain intensity and stain area scores at each post-baseline time point.	Baseline to Days 7, 14, 28, and 42

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject-Reported Whitening and Sensory Assessments	Subject-reported perceptions of whitening, mouthfeel, and sensory responses collected via questionnaires.	Baseline and Days 7, 14, 28, and 42

Collaborators and Investigators

• Sponsor: Church & Dwight Company, Inc.
• Investigators: Study Director: Annahita Ghassemi, PhD, Church & Dwight, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2024
• Primary Completion (Actual): September 20, 2024
• Study Completion (Actual): September 20, 2024

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: tooth whitening; extrinsic stain; whitening toothpaste; Macpherson Lobene Stain Index; dentifrice; stain removal
• Other Study ID Numbers: ST-24-U46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The sponsor does not plan to share individual participant data. Aggregate results are reported, but no de-identified datasets will be made publicly available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No