Phase 2
N=162
The Clinical Investigation of a Zinc Based Toothpaste in Reducing Plaque and Gingivitis
Dental Plaque and Gingivitis
Bottom Line
View on ClinicalTrials.gov: NCT02243046 ↗Enrolled (actual)
162
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Gingivitis Scores — 1.48; 1.57; 1.49 units on a scale — p=0.091
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Control toothpaste (Drug); Experimental toothpaste (Drug); Active Comparator (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Colgate Palmolive
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gingivitis Scores |
1.44; 1.23; 1.19 | < 0.001 sig |
| PRIMARY Gingivitis Scores |
1.44; 1.23; 1.19 | < 0.001 sig |
| PRIMARY Gingivitis Scores |
1.44; 1.23; 1.19 | < 0.001 sig |
| PRIMARY Dental Plaque Scores |
2.47; 1.82; 1.75 | < 0.001 sig |
| PRIMARY Dental Plaque Scores |
2.47; 1.82; 1.75 | < 0.001 sig |
| PRIMARY Dental Plaque Scores |
2.47; 1.82; 1.75 | < 0.001 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Subjects, ages 18-70, inclusive.
- Availability for the six-month 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 period 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 that 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 (NCT02243046). 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.