A New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems

Colgate-Palmolive

Status and phase

Completed

Phase 3

Conditions

Gum Disease

Plaque

Treatments

Drug: 0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash

Drug: 0.057% sodium fluoride Mouthwash

Study type

Interventional

Funder types

Industry

Identifiers

NCT05821712

CRO-2020-12-PGN-MMW-ITA-YPZ

Details and patient eligibility

About

This 6-month clinical study was designed to investigate clinical efficacy on plaque and gingivitis for the Meridol Base Mouthwash containing 0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride as compared to a Negative Control Mouthwash containing 0.057% sodium fluoride after 3 and 6 months of product use.

Enrollment

80 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects, ages 18-70, inclusive.
Availability for the six-month duration of the clinical research study.
Good general health.
Initial gingivitis index of at least 1.0 as determined by the use of the Loe-Silness Gingival Index.
Initial plaque index of at least 1.5 as determined by the use of the Quigley-Hein Plaque Index.
Signed Informed Consent Form

Exclusion criteria

Presence of orthodontic bands.
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.
Self-reported pregnant or lactating subjects