Overview

Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis

Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
0
Participant gender:
All
Summary
The objective of this study is to evaluate the performance of two toothpastes in controlling established gingivitis and dental plaque in adults.
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Colgate Palmolive
Treatments:
Fluorides
Triclosan
Criteria
Inclusion Criteria:

- Availability for the six-month duration of the study.

- Good general health.

- Minimum of 20 uncrowned permanent natural teeth (excluding third molars).

- Initial gingivitis index of at least 1.0 as determined by the use of the Loe and
Silness Gingival Index.

- Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein
Plaque Index (Turesky Modification).

- Signed Informed Consent Form.

Exclusion Criteria:

- Presence of orthodontic bands.

- Presence of partial removable dentures.

- Tumor(s) of the soft or hard tissues of the oral cavity.

- Advanced periodontal disease (purulent exudate,tooth mobility, and/or extensive loss
of

- periodontal attachment or alveolar bone).

- Five or more carious lesions requiring immediate restorative treatment.

- Use of antibiotics any time during the one month prior to entry into the study.

- Participation in any other clinical study or test panel within the one month prior to
entry

- into the study.

- Pregnant women or women who are breast feeding.

- Receive a dental prophylaxis in the past two weeks prior to baseline examinations.

- History of allergic to personal care/consumer products or their ingredients.

- Taking any prescription medicines. That might interfere with the study outcome.

- Individuals with an existing medical condition which prohibits them from not eating or
drinking for periods up to 4 hours.