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

NCT07263698 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: CRO-2025-10-PGN-PRG-ITA-YPZ
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gingivitis; Plaque, Dental

Keywords

Quigley-Hein Plaque Index; Modified Gingival

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Test 1 mouthwash

EXPERIMENTAL

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

Test 2 mouthwash

ACTIVE COMPARATOR

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

Interventions

sodium fluoride Mouthwash DRUG

100 ppm F as sodium fluoride

Test 2 mouthwash

cetylpyridinium chloride (CPC), zinc lactate and sodium fluoride Mouthwash DRUG

0.09% CPC, 0.28% zinc lactate and 500 ppm F as sodium fluoride

Test 1 mouthwash

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Clinica Odontoiatrica Montesani

Roma, Rome, 00187, Italy

Location

MeSH Terms

Conditions

Gingivitis; Dental Plaque

Interventions

Cetylpyridinium; cytidylyl-(3'-5')-cytidine

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Intervention Hierarchy (Ancestors)

Pyridinium Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Luigi Montesani, DDS

  University of Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: December 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

IT (1)