Staining
Conditions
Keywords
whitening, stains, perceptions
Brief summary
Clinical study to assess the efficacy of professional tooth whitening maintenance system of a Colgate toothpaste containing 5% Hydrogen Peroxide with a stain-fighter mouthwash as compared to only the stainfighter mouthwash and a negative control toothpaste
Interventions
OTHERwhitening maintenance
whitening maintenance regimen
OTHERwhitening maintenance MW
maintenance MW
OTHERnegative control
negative control
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* permanent natural teeth (6-11) (22-27) * composite lobene =\>1 * Signed Informed Consent Form * Male and female subjects aged 18-70 years, inclusive * Good general health and good oral health based on the opinion of the study investigator * All maxillary anterior teeth (teeth #6 through #11) must be present;& mandibular anterior ( Teeth #22 through 27) must be present * Availability for the duration of the study * Minimum average Vita Extended Bleachedguide 3D-Master shade score of 17 ≥ or darker * A minimum mean of 1.5 ≥ determined by the Interproximal Modified Lobene (IML) Stain Index * Demonstrate a tendency to form stain in anterior teeth/ Have high staining habits ( coffee/ wine/ tea drinker)
Exclusion criteria
* allergies * Presence of orthodontic appliances or any anterior tooth with a prosthetic crown or veneer * Restorations on the tooth to be scored which may interfere with scoring procedures * 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 * Concurrent participation in another clinical study * Self-reported pregnant and/or lactating women * History of allergies to tooth whitening products, hydrogen peroxide, personal care consumer products, or their ingredients * Have dentinal sensitivity * Taking medication within a year which could alters natural tooth color or appearance, * Have used Professional Whitening product within a year or had a dental prophylaxis ( professional dental cleaning) within 30 days prior to the start of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tooth color assessment | Baseline | Changes in Tooth color determined by examiner use of Vita Extended Bleachedguide 3D-Master®(29 tabs) |
| Interproximal Modified Lobene Stain Index | Baseline | Stain examination will be determined by the Interproximal Modified Lobene(IML) Stain Index |
Countries
United States
Outcome results
None listed