Investigation of Clinical Efficacy of a New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems as Compared to a Control Mouthwash

Investigation of Clinical Efficacy of a New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems as Compared to a Control Mouthwash - a Three-month Study in Italy

Qualified subjects will be enrolled and randomized to either one of the two study groups described above based on their initial modified gingivitis and plaque scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after two weeks, six weeks and three months of product use. All subjects will be followed for adverse events throughout the study

Study Overview

• Status: Completed
• Conditions: Gingivitis; Plaque, Dental
• Intervention / Treatment: Drug: cetylpyridinium chloride (CPC), zinc lactate and sodium fluoride Mouthwash; Drug: sodium fluoride 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:

• Subjects, ages 18-70, inclusive.
• Availability for the three-month duration of the clinical research study.
• Good general health.
• Initial modified gingivitis index of at least 1.5 as determined by the use of the Modified Gingival Index.
• Initial plaque index of at least 1.5 as determined by the use of the Quigley-Hein Plaque Index.
• Signed Informed Consent Form (Appendix C)

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).
• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test 1 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 each mouthwash rising. Each qualified subject will follow this specific application for 3 months	Drug: cetylpyridinium chloride (CPC), zinc lactate and sodium fluoride Mouthwash; 0.09% CPC, 0.28% zinc lactate and 500 ppm F as sodium fluoride
Active Comparator: Test 2 mouthwash; After brushing either in the morning or in the evening, 20 ml of the mouthwash shall be used for each rinsing, 2 times daily (morning and evening) for 30 seconds each time	Drug: sodium fluoride Mouthwash; 100 ppm F as sodium fluoride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Gingival Index	A Modified Gingivitis Index score from 0 to 4 will be assigned by the examiner to all tooth surfaces. In regards to the scale, lower number is a better outcome.	baseline, 2 week, 6 week & 3 month
Saxton Bleeding Index	Gingival bleeding is assessed 30 seconds after probing; a score of 0 represents an absence of bleeding. a score of 1 is given if bleeding is observed within 30 seconds after probing and a score of 2 is given if bleeding is observed immediately on probing	baseline, 2 week, 6 week & 3 month
Modified Quigley-Hein Plaque Index	Modified Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed tooth surfaces. In regards to the scale, lower number is a better outcome.	baseline, 2 week, 6 week & 3 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): December 1, 2025
• Primary Completion (Actual): February 27, 2026
• Study Completion (Actual): February 27, 2026

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): December 4, 2025

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Quigley-Hein Plaque Index; Modified Gingival
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Infections; Gingival Diseases; Dental Deposits; Dental Plaque; Gingivitis; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridinium Compounds; Cetylpyridinium; cytidylyl-(3'-5')-cytidine
• Other Study ID Numbers: CRO-2025-10-PGN-PRG-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