Status:
COMPLETED
The Clinical Investigation of a Zinc Based Toothpaste in Reducing Plaque and Gingivitis
Lead Sponsor:
Colgate Palmolive
Conditions:
Dental Plaque and Gingivitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT02243046
Start Date
December 1 2014
End Date
May 1 2015
Last Update
February 25 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Spa Dental
Santo Domingo, Dominican Republic