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.

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Drug: PhosFlur Mouthwash; Drug: Cetylpyridinium Chloride, Zinc Lactate and Hyaluronic Acid Mouthwash

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Rome
    • Roma, Rome, Italy, 00187
      • Clinica Odontoiatrica Montesani

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: PhosFlur Mouthwash; 0 .044 % sodium fluoride
Experimental: 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	Drug: Cetylpyridinium Chloride, Zinc Lactate and Hyaluronic Acid Mouthwash; 0 .075 % cetylpyridinium chloride and 0 .28 % zinc lactate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mombelli Modified Gingival Index	Initial mucositis index of at least 1.0 as determined by the use of the Mombelli Modified Gingival	baseline
Mombelli Modified Gingival Index	Initial mucositis index of at least 1.0 as determined by the use of the Mombelli Modified Gingival	three month
Mombelli Modified Gingival Index	Initial mucositis index of at least 1.0 as determined by the use of the Mombelli Modified Gingival	six month
Mombelli Modified Plaque Index	Initial plaque index of at least 1 .5 as determined by the use of the Mombelli Modified Plaque	baseline
Mombelli Modified Plaque Index	Initial plaque index of at least 1 .5 as determined by the use of the Mombelli Modified Plaque	three month
Mombelli Modified Plaque Index	Initial plaque index of at least 1 .5 as determined by the use of the Mombelli Modified Plaque	six month

Collaborators and Investigators

• Sponsor: Colgate Palmolive
• Investigators: Principal Investigator: Luigi Montesani, DDS, University of Rome

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Actual): May 9, 2022
• Study Completion (Actual): May 9, 2022

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Gingivitis; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridinium Compounds; Cetylpyridinium
• Other Study ID Numbers: CRO-2021-12-PIM-IMW-ITA-YPZ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes