Stain Removal Efficacy
Conditions
Keywords
tooth whitening; extrinsic stain; whitening toothpaste; Macpherson Lobene Stain Index; dentifrice; stain removal
Brief 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.
Interventions
OTHERWhitening Test Dentifrice (Code 826)
Whitening toothpaste used twice daily for two minutes per brushing for six weeks.
OTHERControl dentifrice (Code 378)
Non-whitening toothpaste used twice daily for two minutes per brushing for six weeks.
Sponsors
Church & Dwight Company, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
STUDY_DIRECTORAnnahita Ghassemi, PhD
Church & Dwight, Inc.
Outcome results
None listed