The Clinical Investigation of a Zinc Based Toothpaste in Reducing Plaque and Gingivitis

Colgate-Palmolive

Status and phase: Completed; Phase 2

Conditions: Dental Plaque and Gingivitis

Treatments: Drug: Active Comparator; Drug: Control toothpaste; Drug: Experimental toothpaste

Study type: Interventional

Funder types: Industry

Identifiers

NCT02243046

CRO-2014-11-PG-ZNPTCN-ED

Details and patient eligibility

About

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.

Enrollment: 162 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Subjects, ages 18-70, inclusive.
2. Availability for the six-month duration of the clinical research 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. Antibiotic use any time during the one-month period 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. Dental prophylaxis during the past two weeks prior to baseline examinations.
9. History of allergies to oral care/personal care consumer products or their ingredients.
10. On any prescription medicines that might interfere with the study outcome.
11. An existing medical condition that prohibits eating or drinking for periods up to 4 hours.
12. History of alcohol or drug abuse.
13. Pregnant or lactating subjects.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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162 participants in 3 patient groups, including a placebo group

Control toothpaste

Placebo Comparator group

Description:

1450 ppm Fluoride toothpaste

Treatment:

Drug: Control toothpaste

Experimental toothpaste

Experimental group

Description:

1450 ppm sodium fluoride toothpaste with a zinc base

Treatment:

Drug: Experimental toothpaste

Active comparator

Active Comparator group

Description:

1450 ppm sodium fluoride/triclosan toothpaste

Treatment:

Drug: Active Comparator