Health Condition 1: K039- Disease of hard tissues of teeth,unspecified
Conditions
Interventions
Intervention1: Whitening toothpaste group: 14 days of brushing with the product twice daily for two minutes
Control Intervention1: Non-whitening toothpaste group: 14 days of brushing with the product
Sponsors
Colgate-Palmolive
Eligibility
Inclusion criteria
Inclusion criteria: Potential subjects must meet ALL of the following criteria: 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; Present twelve (12) scorable natural anterior teeth (free of large restorations or prosthetics). Availability for the duration of the study; Self reported consumption of tea, coffee or tobacco = 2 times a day. A minimum mean Composite Lobene Index score of 1 or greater. Clinical evidence of a tendency to form stains on anterior teeth.
Exclusion criteria
Exclusion criteria: Potential subjects must NOT HAVE ANY of the following conditions: Presence of orthodontic appliances or any anterior tooth with a prosthetic crown or veneer. Presence of partial removable dentures. Tumors or significant pathology of the soft or hard tissues of the oral cavity. Presence of anterior teeth with severe or atypical staining, which include tetracycline or hypo-calcification. Use of antibiotics or stain inducing medications any time during the one month prior to entry into the study. Dental prophylaxis received in the past four weeks prior to baseline examinations or usage of whitening toothpaste. History of alcohol or drug abuse. Exposed to a tooth whitening procedure during the last 3 months. Moderate periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone) or any other condition that the dental examiner considers would exclude you from participation. Five or more carious lesions requiring immediate restorative treatment. History of allergy to consumer or personal care products as determined by the dental professional monitoring the study. Participation in any other clinical study or test panel within the 30-day period prior to entering into the study. Pregnant women or women who are breast-feeding. Medical conditions that the investigator considers significant which may compromise the subject’s safety as well as the quality of the study results. Restorations on the teeth to be scored which may interfere with scoring procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Tooth stain determined by examiner use Lobene StainTimepoint: Baseline, 7 days and 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| N/ATimepoint: N/A | — |
Countries
India
Contacts
Public ContactDr Bhuvana Gurumurthy
Colgate-Palmolive India Limited
Outcome results
None listed