NCT07263698

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Colgate Palmolive · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	cetylpyridinium chloride (CPC), zinc lactate and sodium fluoride Mouthwash	0.09% CPC, 0.28% zinc lactate and 500 ppm F as sodium fluoride
DRUG	sodium fluoride Mouthwash	100 ppm F as sodium fluoride

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2025-12-04
• Last updated: 2026-01-14

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated drug study