NCT02360995 - The Clinical Investigation of Toothpaste as Compared to Toothpaste and Mouthwash in Reducing Plaque and Gingivitis: A Six-week Clinical Study in the US | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

129

Conditions

Dental Plaque Gingivitis

Interventions

Triclosan/fluoride toothpasteDRUG

Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).

stannous fluoride toothpasteDRUG

Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration).

fluoride toothpasteDRUG

Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects, ages 18-70, inclusive. 2. Availability for the six-week duration of the clinical research study. 3. Good general health. 4. Minimum of 20 uncrowned permanent natural teeth (excluding third molars). 5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index. 6. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification). 7. Signed Informed Consent Form Exclusion Criteria: 1. Presence of orthodontic bands. 2. Presence of partial removable dentures. 3. Tumor(s) of the soft or hard tissues of the oral cavity. 4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). 5. Five or more carious lesions requiring immediate restorative treatment. 6. Antibiotic use any time during the one month prior to entry into the study. 7. Participation in any other clinical study or test panel within the one month prior to entry into the study. 8. Dental prophylaxis during the past two weeks prior to baseline examinations. 9. History of allergies to oral care/personal care consumer products or their ingredients. 10. On any prescription medicines that might interfere with the study outcome. 11. An existing medical condition which prohibits eating or drinking for periods up to 4 hours. 12. History of alcohol or drug abuse. 13. Pregnant or lactating subjects.

Locations (1)

Loma Linda University

Loma Linda, California, United States

Outcomes

Primary Outcomes

Dental Plaque Scores

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)

Time frame: Baseline

Dental Plaque Scores

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)

Time frame: 4 weeks

Dental Plaque Scores

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)

Time frame: 6 weeks

Gingivitis Scores

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)

Time frame: Baseline

Gingivitis Scores

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)