Clinical Study Comparing Dental Plaque and Gingivitis Reduction After Using One of Three Oral Hygiene Multi-component Regimens (Using of a Manual Toothbrush, a Toothpaste and a Mouthwash)

Phase 4

Completed

Interventions: Drug: Triclosan/fluoride toothpaste
Drug: stannous fluoride toothpaste
Drug: fluoride only toothpaste
Drug: Cetylpyridinium chloride mouthwash
Drug: Fluoride only mouthwash

Brief Summary: The objective of this clinical research study is to assess the efficacy of a commercially available triclosan/copolymer toothpaste compared to a commercially available oral hygiene multi-component regimen encompassing the use of a manual toothbrush, a toothpaste containing stannous fluoride / sodium hexametaphosphate and a mouthwash containing cetylpyridinium chloride relative to a negative control regimen in reducing established dental plaque and gingivitis over three and six months of assigned product use.

Recruitment & Eligibility

Inclusion Criteria

Male and female subjects, ages 18-70, inclusive.
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.
Dental prophylaxis received in the past two weeks prior to baseline examinations.
History of allergies to oral care/personal care consumer products or their ingredients.
On any prescription medicines that might interfere with the study outcome.
An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
History of alcohol or drug abuse

Arm && Interventions

Group	Intervention	Description
Toothpaste	Triclosan/fluoride toothpaste	Triclosan/fluoride toothpaste
Toothpaste + mouthwash	stannous fluoride toothpaste	stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
Toothpaste + mouthwash	Cetylpyridinium chloride mouthwash	stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
Fluoride only Toothpaste + mouthwash	fluoride only toothpaste	Fluoride only toothpaste + Fluoride only Mouthwash
Fluoride only Toothpaste + mouthwash	Fluoride only mouthwash	Fluoride only toothpaste + Fluoride only Mouthwash

Primary Outcome Measures

Name	Time	Method
Gingivitis Scores	6 months	Gingivitis scale (Loe \& Silness Gingival Index) 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)
Dental Plaque Scores	6 months	Dental Plaque (Quigley-Hein, Turesky Modification Index) 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)

Secondary Outcome Measures