Phase 4
N=179
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)
Dental Plaque · Gingivitis
Bottom Line
View on ClinicalTrials.gov: NCT02366689 ↗Enrolled (actual)
179
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Dental Plaque Scores — 3.33; 3.22; 3.34 units on a scale — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Triclosan/fluoride toothpaste (Drug); stannous fluoride toothpaste (Drug); fluoride only toothpaste (Drug); Cetylpyridinium chloride mouthwash (Drug); Fluoride only mouthwash (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Colgate Palmolive
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dental Plaque Scores |
1.84; 1.86; 2.37 | <0.001 sig |
| PRIMARY Dental Plaque Scores |
1.84; 1.86; 2.37 | <0.001 sig |
| PRIMARY Dental Plaque Scores |
1.84; 1.86; 2.37 | <0.001 sig |
| PRIMARY Gingivitis Scores |
1.17; 1.18; 1.85 | <0.001 sig |
| PRIMARY Gingivitis Scores |
1.17; 1.18; 1.85 | <0.001 sig |
| PRIMARY Gingivitis Scores |
1.17; 1.18; 1.85 | <0.001 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Male and female subjects, ages 18-70, inclusive.
- Availability for the six-month duration of the 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.
- Use of antibiotics 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.
- Pregnant women or women who are breast feeding.
- Dental prophylaxis received in 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
Data sourced from ClinicalTrials.gov (NCT02366689). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.