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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-08

Study Completion Date

2021-09-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Plaque Gum Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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

mouthwash

Group Type EXPERIMENTAL

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

Intervention Type DRUG

mouthwash

0.057% sodium fluoride Mouthwash

mouthwash

Group Type ACTIVE_COMPARATOR

0.057% sodium fluoride Mouthwash

Intervention Type DRUG

mouthwash

Interventions

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

mouthwash

Intervention Type DRUG

0.057% sodium fluoride Mouthwash

mouthwash

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes