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

Colgate-Palmolive

Status and phase: Completed; Phase 3

Conditions: Gingivitis

Treatments: Drug: Cetylpyridinium Chloride, Zinc Lactate and Hyaluronic Acid Mouthwash; Drug: PhosFlur Mouthwash

Study type: Interventional

Funder types: Industry

Identifiers

NCT06770114

CRO-2021-12-PIM-IMW-ITA-YPZ

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

New Mouthwash containing CPC, Zinc and Hyaluronic acid

Experimental group

Description:

After brushing in the morning and in the evening, 20 ml of mouthwash shall be used for each rinsing, 2 times daily (morning and evening ) for 30 seconds each time. No further rinsing with water shall be occurred after spilt out and after each mouthwash rising. Each qualified subject will follow this specific application for 6 months

Treatment:

Drug: Cetylpyridinium Chloride, Zinc Lactate and Hyaluronic Acid Mouthwash

Fluoride Mouthwash

Active Comparator group

Description:

After brushing in the morning, 10 ml of mouthwash shall be used for each rinsing, 1 time daily (morning ) for 60 seconds each time. No further rinsing with water shall be occurred after spilt out and after each mouthwash rising. Each qualified subject will follow this specific application for 6 months.

Treatment:

Drug: PhosFlur Mouthwash