Extrinsic Tooth Whitening Evaluation of a Whitening Toothpaste

Conditions

• Stain Removal Efficacy

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Aug 8, 2024

Status verified

Feb 2026

Primary completion

Sep 20, 2024

Completion

Sep 20, 2024

Study Design

Enrollment

118 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Experimental: Test Toothpaste
  Investigational whitening toothpaste evaluated for removal of extrinsic tooth stain over 42 days of use.
• Other: Sodium Fluoride Control Dentifrice
  Non-whitening toothpaste used twice daily for two minutes per brushing for six weeks.

Primary Outcome Measure

Change in Extrinsic Tooth Stain (Total Stain Score) [ Time Frame: Baseline to Day 42 ]

Locations (1)

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