Dental Plaque and Gingivitis Clinical Trial
Official title:
The Clinical Investigation of a Zinc Based Toothpaste as Compared to a Triclosan Based Toothpaste and Colgate Fluoride Toothpaste in Reducing Established Plaque and Gingivitis - a Six-month Study.
| Verified date | July 2015 |
| Source | Colgate Palmolive |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a six (6) month, double-blind, parallel, controlled clinical trial utilizing one hundred and sixty (160) adults to evaluate the reduction of dental plaque and gingivitis.
| Status | Completed |
| Enrollment | 162 |
| Est. completion date | May 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria 1. Subjects, ages 18-70, inclusive. 2. Availability for the six-month 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 period 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 that prohibits eating or drinking for periods up to 4 hours. 12. History of alcohol or drug abuse. 13. Pregnant or lactating subjects. |
| Country | Name | City | State |
|---|---|---|---|
| Dominican Republic | Spa Dental | Santo Domingo |
| Lead Sponsor | Collaborator |
|---|---|
| Colgate Palmolive |
Dominican Republic,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | Baseline | |
| Primary | 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) | 3 months (from Baseline) | |
| Primary | 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) | 6 months (from Baseline) | |
| Primary | 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) | Baseline | |
| Primary | 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) | 3 months (from Baseline) | |
| Primary | 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) | 6 months (from Baseline) |