Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis

Phase 3

Completed

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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
A -Experimental toothpaste	Triclosan, fluoride	triclosan/copolymer/fluoride toothpaste
B - control toothpaste	Fluoride	sodium fluoride only toothpaste (placebo)

Primary Outcome Measures

Name	Time	Method
Gingivitis Index	6 months	Units on a scale 0 to 3 (0 = no inflammation , 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)
Plaque Index	6 Months	Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)