Phase 4
N=129
The Clinical Investigation of Toothpaste as Compared to Toothpaste and Mouthwash in Reducing Plaque and Gingivitis: A Six-week Clinical Study in the US
Dental Plaque · Gingivitis
Bottom Line
View on ClinicalTrials.gov: NCT02360995 ↗Enrolled (actual)
129
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Dental Plaque Scores — 3.91; 3.86; 3.84 units on a scale — p=0.652
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Triclosan/fluoride toothpaste (Drug); stannous fluoride toothpaste (Drug); fluoride toothpaste (Drug); Fluoride Mouthwash (Drug); cetylpyridinium chloride Mouthwash (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Colgate Palmolive
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dental Plaque Scores |
1.05; 1.15; 1.24 | <0.001 sig |
| PRIMARY Dental Plaque Scores |
1.05; 1.15; 1.24 | <0.001 sig |
| PRIMARY Dental Plaque Scores |
1.05; 1.15; 1.24 | <0.001 sig |
| PRIMARY Gingivitis Scores |
1.05; 1.15; 1.24 | <0.001 sig |
| PRIMARY Gingivitis Scores |
1.05; 1.15; 1.24 | <0.001 sig |
| PRIMARY Gingivitis Scores |
1.05; 1.15; 1.24 | <0.001 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Subjects, ages 18-70, inclusive.
- Availability for the six-week duration of the 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.
Data sourced from ClinicalTrials.gov (NCT02360995). 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.