Efficacy of Manual Toothbrushes in Removing Tooth Stains
- Registration Number
- NCT06486974
- Lead Sponsor
- Colgate Palmolive
- Brief Summary
Efficacy of Manual Toothbrushes in Removing Tooth Stains: A 6-Week Clinical Research Study.
- Detailed Description
The aim of this study is to evaluate the effectiveness of manual toothbrushes in reducing tooth staining after 6 weeks of unsupervised, daily use by participants.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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 Lobene Tooth Stain Index;
- Available for the duration of the study;
- Clinical evidence of a tendency to form extrinsic stains on anterior teeth.
- 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 to oral care/personal care consumer products or their ingredients;
- History of alcohol and/or drug abuse.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 NaF Colgate MaxFresh Toothpaste - 0.243% NaF (1100 ppm F) Total Polish 23 CHS TB Colgate Active Prevention Manual Toothbrush Group 2 Na MFP Colgate Great Regular Flavor Toothpaste - 0.76% Na MFP (1000 ppm F) Colgate Adult Extra Clean soft-bristle toothbrush
- Primary Outcome Measures
Name Time Method Lobene Tooth Stain Index Baseline, and 6-weeks Each tooth will be scored separately using a 4 point area Stain Area (extent):
(0) No stain detected
1. Stain covering up to one third (1/3) of the region
2. Stain covering \> 1/3 to 2/3 of the region
3. Stain covering \> 2/3 of the region
Stain Intensity:
(0) No stain
1. Light Stain - yellow to light brown or gray
2. Moderate stain - medium brown
3. Heavy stain - dark brown to black and intensity scale ranging from: Using the Lobene Tooth Stain Index, each tooth will be scored separately using a 4 point area and intensity scale ranging from:
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Spa Dental
🇩🇴Santo Domingo, Dominican Republic