Six Month Plaque and Gingivitis Study Using Colgate Total Toothpaste

Phase 4

Completed

Interventions: Drug: Colgate Cavity Protection toothpaste
Drug: Colgate Total toothpaste
Drug: Parodontax toothpaste

Brief Summary: The objective of this randomized, single center, parallel clinical research study is to evaluate the comparative efficacy performance of three dentifrices -Colgate Total Toothpaste, Parodontax Toothpaste and Colgate Cavity Protection Toothpaste in controlling gingivitis and dental plaque in adults.

Recruitment & Eligibility

Inclusion Criteria

Subjects, ages 18-70, inclusive.
Availability for the six-month duration ofthe 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
Colgate Cavity Protection toothpaste	Colgate Cavity Protection toothpaste	Brush whole mouth 2x/day with Colgate Cavity Protection toothpaste. This study treatment is currently marketed/sold in Poland
Colgate Total toothpaste	Colgate Total toothpaste	Brush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland
Parodontax	Parodontax toothpaste	Brush whole mouth 2x/day with Parodontax toothpaste. This study treatment is currently marketed/sold in Poland.

Primary Outcome Measures

Name	Time	Method
Dental Plaque Score	6 months post treatment use	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 months post treatment use	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