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

NCT ID: NCT07263698

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

sodium fluoride Mouthwash

Intervention Type: DRUG

100 ppm F as sodium fluoride

Interventions

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

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

Intervention Type: DRUG

sodium fluoride Mouthwash

100 ppm F as sodium fluoride

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luigi Montesani, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Rome

Locations

Clinica Odontoiatrica Montesani

Roma, Rome, Italy

Countries

Italy

Other Identifiers

CRO-2025-10-PGN-PRG-ITA-YPZ

Identifier Type: -

Identifier Source: org_study_id