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

Phase 3

Completed

• Conditions: Plaque; Gum Disease
• Interventions: Drug: 0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash; Drug: 0.057% sodium fluoride Mouthwash

• Registration Number: NCT05821712
• Lead Sponsor: Colgate Palmolive

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-08
• Primary Completion: 2021-09-24
• Study Completion: 2021-09-24
• Study First Submitted: 2023-03-27
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-07
• Last Update Submitted: 2023-04-07
• Study First Posted: 2023-04-20
• Last Update Posted: 2023-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash	0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash	mouthwash
0.057% sodium fluoride Mouthwash	0.057% sodium fluoride Mouthwash	mouthwash

Primary Outcome Measures

Name	Time	Method
Gingival inflammation	6 months	Loe-Silness Gingival Index

Trial Locations

Locations (1)

Clinica Odontoiatrica Montesani; 🇮🇹 Roma, Rome, Italy