MedTrace Logo

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

NCT07263698 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-01-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Colgate Palmolive

    lead INDUSTRY

Principal Investigators

  • Luigi Montesani, DDS · University of Rome

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2026-03-31
Completion
2026-03-31
FDA Drug
Yes

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07263698 on ClinicalTrials.gov