Whitening
Conditions
Keywords
Hydrogen Peroxide
Brief summary
The aim of this study is to evaluate and compare the immediate efficacy of a hydrogen peroxide-containing toothpaste versus a regular fluoride toothpaste without hydrogen peroxide in removing extrinsic tooth stains following a single supervised brushing in healthy adult participants.
Interventions
0.76% Na MFP
DRUGOptic White Adv Sparkling White (2%HP) Toothpaste
0.243% NaF toothpaste
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed Informed Consent Form; * Male and female subjects, aged 18-70, inclusive; * Good general health and good oral health based on the opinion of the study investigator; - Presence of permanent natural anterior teeth (no veneers/crowns/restorations that may interfere with this study scoring procedures); * A minimum composite mean of ≥ 1.5 determined by the Mod. Lobene Tooth Stain Index; * Available for the duration of the study; * Clinical evidence of a tendency to form extrinsic stains on anterior teeth
Exclusion criteria
* Presence of orthodontic appliances/retainers involving scorable teeth; * Presence of partial removable/fixed dentures and/or restorations involving scorable teeth; 3. Tumor(s) of the soft or hard tissues of the oral cavity; * Obvious signs of periodontal disease rampant caries, or any condition that the dental examiner considers exclusionary from the study; * Five or more carious lesions requiring immediate care; * Use of antibiotics, stain-inducing medications, and/or on any prescription that might interfere with the study outcome; * Concurrent participation in another clinical study; * Self-reported pregnancy and/or lactating women; * Have used professional whitening product within one (1) year or had a dental prophylaxis (professional dental cleaning) within thirty (30) days - prior to the start of the study * History of allergies or sensitivity to tooth whitening products, hydrogen peroxide, personal care consumer products, or their ingredients; * History of alcohol and/or drug abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mod. Lobene Stain Index | one day | each tooth will be scored separately using a 4 point area and intensity scale |
Countries
Dominican Republic
Outcome results
None listed