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)
| Status: | Completed |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | June 2014 |
| End Date: | December 2014 |
Clinical Efficacy in Reducing Established Dental Plaque and Gingivitis of a Toothpaste Containing 0.3% Triclosan, 2% Copolymer / Sodium Fluoride and a Manual Toothbrush as Compared to an Oral Hygiene Multi-component Regimen Encompassing the Use of a Manual Toothbrush, a Toothpaste Containing Stannous Fluoride / Sodium Hexametaphosphate and a Mouthwash Containing 0.07% Cetylpyridinium Chloride
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.
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.
Inclusion Criteria:
1. Male and female subjects, ages 18-70, inclusive.
2. Availability for the six-month duration of the 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. Use of antibiotics 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. Pregnant women or women who are breast feeding.
9. Dental prophylaxis received in the past two weeks prior to baseline examinations.
10. History of allergies to oral care/personal care consumer products or their
ingredients.
11. On any prescription medicines that might interfere with the study outcome.
12. An existing medical condition which prohibits eating or drinking for periods up to 4
hours.
13. History of alcohol or drug abuse
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