Health Condition 1: K037- Posteruptive color changes of dental hard tissues
Conditions
Sponsors
Colgate-Palmolive
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed Informed Consent Form. 2. Male and female subjects aged 18-70 years, inclusive. 3. Good general health and good oral health. 4. Availability for the duration of the study. 5. Present twelve (12) scorable natural anterior teeth (free of large restorations or prosthetics). 6. A minimum mean Composite Lobene Index score of 1 or greater. 7. 50% of subjects are current tobacco users. 8. Clinical evidence of a tendency to form extrinsic stains on anterior teeth.
Exclusion criteria
Exclusion criteria: 1. Presence of orthodontic appliances or any anterior tooth with a prosthetic crown or veneer. 2. Presence of partial removable dentures. 3. Tumors or significant pathology of the soft or hard tissues of the oral cavity. 4. Presence of anterior teeth with severe or atypical staining, which include tetracycline or hypo-calcification. 5. Use of antibiotics or stain inducing medications any time during the one month prior to entry into the study. 6. Dental prophylaxis received in the past four weeks prior to baseline examinations or usage of whitening toothpaste. 7. History of alcohol or drug abuse. 8. Exposed to a tooth whitening procedure during the last 3 months. 9. Moderate periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). 10. Five or more carious lesions requiring immediate restorative treatment. 11. History of allergy to consumer or personal care products as determined by the dental professional monitoring the study. 12. Participation in any other clinical study or test panel within the 30-day period prior to entering into the study. 13. Pregnant women or women who are breast-feeding. 14. Medical conditions that the investigator considers significant which may compromise the subject’s safety as well as the quality of the study results. 15. Restorations on the teeth to be scored which may interfere with scoring procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Inter and intra examiner reproducibilityTimepoint: Inter examiner reproducibility - Visit 1 and 2 Intra examiner reproducibility - Visit 3 and 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| N/ATimepoint: N/A | — |
Countries
India
Contacts
Public ContactDr Bhuvana Gurumurthy
Colgate-Palmolive India Limited
Outcome results
None listed