NCT07276672CompletedPhase 3
Efficacy of a Toothpaste Containing Hydrogen Peroxide as Compared to a Regular Fluoride Toothpaste Without Hydrogen Peroxide in the Immediate Removal of Tooth Stains After a Single Brushing
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Colgate Palmolive
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Mod. Lobene Stain Index
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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;
- •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.
Arms & Interventions
Test 1 toothpaste
Experimental
2%HPToothpaste
Intervention: Optic White Adv Sparkling White (2%HP) Toothpaste (Drug)
Test 2 toothpaste
Active Comparator
.76% Na MFP toothpaste
Intervention: Colgate Great Regular Flavor Toothpaste (Drug)
Outcomes
Primary Outcomes
Mod. Lobene Stain Index
Time Frame: one day
each tooth will be scored separately using a 4 point area and intensity scale
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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