Clinical Study to Investigate a New Mouthwash in Reducing Plaque and Helping Prevent Gum Problems on Dental Implants Over a 6-month Period of Product Use

A Clinical Study to Investigate a New Mouthwash Containing 0.075% CPC, and 0.1% Hyaluronic Acid and 0.28% Zinc Lactate as Compared to a Fluoride Mouthwash Containing 0.044% NaF in Reducing Plaque and Helping Prevent Gum Problems on Dental Implants Over a 6-month Period of Product Use

The objective of this six-month clinical research study is to evaluate the clinical efficacy of a new mouthwash on helping prevent gum problems (gingival index scores ) in adults as compared to a control mouthwash.

Inclusion Criteria:

• Availability for the six-month duration of the clinical research study.
• Good general health.
• Minimum of two dental implants (2 different quadrants ), each implant must have a restoration.
• Initial mucositis index of at least 1 .0 as determined by the use of the Mombelli Modified Gingival Index.
• Initial plaque index of at least 1 .5 as determined by the use of the Mombelli Modified 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 ) or peri-implantitis.
• 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