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

Study 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.

Official Title
-----------------
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

Conditions
-----------------
Plaque, Gum Disease

Intervention / Treatment
-----------------
* Drug: 0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash
* Drug: 0.057% sodium fluoride Mouthwash


Participation Criteria
=================
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. History of alcohol or drug abuse. Self-reported pregnant or lactating subjects

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash<br>mouthwash | Drug: 0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash<br>* mouthwash<br>|
| Active Comparator: 0.057% sodium fluoride Mouthwash<br>mouthwash | Drug: 0.057% sodium fluoride Mouthwash<br>* mouthwash<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival inflammation | Loe-Silness Gingival Index | baseline | 
| Gingival inflammation | Loe-Silness Gingival Index | 3 months | 
| Gingival inflammation | Loe-Silness Gingival Index | 6 months |