Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis

Colgate-Palmolive

Status and phase

Completed

Phase 3

Conditions

Gingivitis

Treatments

Drug: Triclosan, fluoride

Drug: Fluoride

Study type

Interventional

Funder types

Industry

Identifiers

CRO-0507-PL-SP-CT-BS

Details and patient eligibility

About

The objective of this study is to evaluate the performance of two toothpastes in controlling established gingivitis and dental plaque in adults.

Enrollment

120 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.