Tooth Discoloration
Conditions
Keywords
Lobene Tooth Stain Index
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.
Interventions
DRUGNaF
Group 1 will be instructed to brush their teeth twice daily/2 minutes each time for the duration of this study
DRUGNa MFP
Group 2 will be instructed to brush their teeth twice daily/2 minutes each time for the duration of this study
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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: |
Countries
Dominican Republic
Contacts
PRINCIPAL_INVESTIGATORFranklin Garcia-Godoy, DDS, MS, PhD
Global Research Consultants
Outcome results
None listed