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

• Status: Completed
• Trial end date: 2021-09-24
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Colgate Palmolive
• Treatments: Fluorides; Listerine; Sodium Fluoride

Criteria

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