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

NCT06770114 | Completed Phase 3 FDA Drug

• 1 other identifier: CRO-2021-12-PIM-IMW-ITA-YPZ
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

New Mouthwash containing CPC, Zinc and Hyaluronic acid

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 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

Fluoride Mouthwash

ACTIVE COMPARATOR

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

Interventions

Cetylpyridinium Chloride, Zinc Lactate and Hyaluronic Acid Mouthwash DRUG

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

New Mouthwash containing CPC, Zinc and Hyaluronic acid

PhosFlur Mouthwash DRUG

0 .044 % sodium fluoride

Fluoride 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:

• 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.

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 ) 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

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Clinica Odontoiatrica Montesani

Roma, Rome, 00187, Italy

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Cetylpyridinium

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic 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: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 13, 2025
• Study Start: October 18, 2021
• Primary Completion: May 9, 2022
• Study Completion: May 9, 2022
• Last Updated: December 1, 2025

Record last verified: 2025-01

Locations

IT (1)