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

Phase 3

Completed

• Conditions: Gingivitis
• Interventions: Drug: Cetylpyridinium Chloride and Zinc Lactate Mouthwash; Drug: PhosFlur Mouthwash

• Registration Number: NCT06770114
• Lead Sponsor: Colgate Palmolive

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-18
• Primary Completion: 2022-05-09
• Study Completion: 2022-05-09
• Status Verified: 2025-01
• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New Mouthwash containing CPC and Zinc	Cetylpyridinium Chloride and Zinc Lactate Mouthwash	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
Fluoride Mouthwash	PhosFlur 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.

Primary Outcome Measures

Name	Time	Method
Mombelli Modified Gingival Index	six month	Initial mucositis index of at least 1.0 as determined by the use of the Mombelli Modified Gingival
Mombelli Modified Plaque Index	six month	Initial plaque index of at least 1 .5 as determined by the use of the Mombelli Modified Plaque

Trial Locations

Locations (1)

Clinica Odontoiatrica Montesani; 🇮🇹 Roma, Rome, Italy