Investigation of Clinical Efficacy of a New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems as Compared to a Control Mouthwash - a Six-month Study in Italy

Colgate Palmolive1 site in 1 country80 target enrollmentMarch 8, 2021

Interventions0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash 0.057% sodium fluoride Mouthwash

Drugs0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash 0.057% sodium fluoride Mouthwash

Overview

Phase: Phase 3
Intervention: 0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash
Conditions: Plaque
Sponsor: Colgate Palmolive
Enrollment: 80
Locations: 1
Primary Endpoint: Gingival inflammation
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 8, 2021

End Date

September 24, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Colgate Palmolive

Responsible Party

Sponsor

Eligibility 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.