Status:
RECRUITING
Efficacy of Manual Toothbrushes in Removing Tooth Stains
Lead Sponsor:
Colgate Palmolive
Conditions:
Tooth Discoloration
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06486974
Start Date
September 23 2024
End Date
October 1 2024
Last Update
September 25 2024
Active Locations (1)
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1
Spa Dental
Santo Domingo, Dominican Republic