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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05821712

Enrollment

Registered

2023-04-20

Start date

2021-03-08

Completion date

2021-09-24

Last updated

2023-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gum Disease, Plaque

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.

Interventions

DRUG0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash

mouthwash

DRUG0.057% sodium fluoride Mouthwash

mouthwash

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Gingival inflammation	baseline	Loe-Silness Gingival Index

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026