Evaluating how well manual toothbrushes remove tooth stains
Efficacy of Manual Toothbrushes in Removing Tooth Stains: A 6-Week Clinical Research Study.
This study tests if using a manual toothbrush with fluoride treatments can help people aged 18-70 reduce tooth stains over six weeks.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Colgate Palmolive Industry-sponsored |
| Locations | 1 site (Santo Domingo) |
| Trial ID | NCT06486974 on ClinicalTrials.gov |
What this trial studies
This clinical research evaluates the effectiveness of manual toothbrushes in reducing tooth discoloration over a 6-week period of unsupervised daily use. Participants will be assessed based on the Lobene Tooth Stain Index to measure the reduction in staining. The study includes both male and female subjects aged 18-70 who have good oral health and a tendency to form extrinsic stains. The intervention involves the use of fluoride treatments alongside the toothbrushes to enhance stain removal.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-70 with natural anterior teeth who are prone to extrinsic tooth staining.
Not a fit: Patients with orthodontic appliances, significant dental restorations, or severe oral health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with effective oral hygiene solutions to improve the appearance of their teeth.
How similar studies have performed: Previous studies have shown varying degrees of success in using manual toothbrushes for stain removal, but this specific approach is being evaluated in a structured clinical setting.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 to oral care/personal care consumer products or their ingredients; * History of alcohol and/or drug abuse.
Where this trial is running
Santo Domingo
- Spa Dental — Santo Domingo, Dominican Republic (Recruiting)
Study contacts
- Principal investigator: Franklin Garcia-Godoy, DDS, MS, PhD — Global Research Consultants
- Study coordinator: Franklin Garcia-Godoy, DDS, MS, PhD
- Email: fgarciagodoy@gmail.com
- Phone: +1 (901) 488-1820
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.