The Clinical Investigation of Toothpaste as Compared to Toothpaste and Mouthwash in Reducing Plaque and Gingivitis: A Six-week Clinical Study in the US

Phase 4

Completed

Interventions: Drug: Triclosan/fluoride toothpaste
Drug: stannous fluoride toothpaste
Drug: fluoride toothpaste
Drug: cetylpyridinium chloride Mouthwash
Drug: Fluoride Mouthwash

Brief Summary: The objective of this clinical research study is to evaluate clinical efficacy of Colgate Total Toothpaste as compared to Crest Pro-Health Toothpaste and Crest Pro-Health Mouthwash, and Crest Cavity Protection Toothpaste and Crest Fluoride Mouthwash in reducing gingivitis and dental plaque in adults in a six-week clinical study.

Recruitment & Eligibility

Inclusion Criteria

Subjects, ages 18-70, inclusive.
Availability for the six-week duration of the clinical research 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.
Antibiotic use 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.
Dental prophylaxis during 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.
Pregnant or lactating subjects.

Arm && Interventions

Group	Intervention	Description
Total 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
Control group	fluoride toothpaste	fluoride toothpaste +fluoride mouthwash
Control group	Fluoride Mouthwash	fluoride toothpaste +fluoride mouthwash

Primary Outcome Measures

Name	Time	Method
Dental Plaque Scores	6 weeks	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)
Gingivitis Scores	6 weeks	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)

Secondary Outcome Measures