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

NCT ID: NCT06770114

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-18
• Study Completion Date: 2022-05-09

Brief Summary

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.

Conditions

Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

New Mouthwash containing CPC, Zinc and Hyaluronic acid

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

Group Type: EXPERIMENTAL

Cetylpyridinium Chloride, Zinc Lactate and Hyaluronic Acid Mouthwash

Intervention Type: DRUG

0 .075 % cetylpyridinium chloride and 0 .28 % zinc lactate

Fluoride Mouthwash

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.

Group Type: ACTIVE_COMPARATOR

PhosFlur Mouthwash

Intervention Type: DRUG

0 .044 % sodium fluoride

Interventions

Cetylpyridinium Chloride, Zinc Lactate and Hyaluronic Acid Mouthwash

0 .075 % cetylpyridinium chloride and 0 .28 % zinc lactate

Intervention Type: DRUG

PhosFlur Mouthwash

0 .044 % sodium fluoride

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luigi Montesani, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Rome

Locations

Clinica Odontoiatrica Montesani

Roma, Rome, Italy

Countries

Italy

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id