Comparative Study of CPC+Zn Mouthwash, Dental Floss, and Essential Oils Mouthwash on Plaque and Gingivitis Reduction (PGMWI)

Clinical Study to Evaluate the Efficacy of Rinsing With an Alcohol Free Mouthwash Containing CPC+Zn as Compared to Dental Flossing and to Rising With an Essential Oils Containing Alcohol Mouthwash in Reducing Dental Plaque and Gingivitis.

Clinical study evaluating the effectiveness of an alcohol-free mouthwash containing CPC+Zn compared to dental flossing and an essential oils-containing alcohol mouthwash in reducing dental plaque and gingivitis. This is a Phase III, single-center, double-blind trial with a parallel design. It involves 120 participants aged between 18 and 65, randomized into different groups, and spans 12 weeks.

Study Overview

• Status: Completed
• Conditions: Gingival Bleeding; Gingivitis and Periodontal Diseases; Plaque Induced Gingival Disease
• Intervention / Treatment: Drug: Mouthwash CPC+Zn+F; Drug: Toothpaste; Device: Toothbrush; Drug: Essential oils mouthrinse; Device: Dental floss

Detailed Description

This clinical study aims to evaluate the efficacy of an alcohol-free mouthwash containing CPC (Cetylpyridinium Chloride) and Zinc (Zn) in reducing dental plaque and gingivitis compared to dental flossing and a mouthwash with essential oils in an alcohol base. It is a Phase III, randomized, double-blind, parallel-group trial involving 120 participants aged 18 to 65. Subjects will be divided into three groups-one using the CPC+Zn mouthwash, another using the essential oils mouthwash, and a control group using dental floss. Each group will also use a fluoride toothpaste and a soft-bristle toothbrush twice daily over 12 weeks. The primary efficacy variable is the reduction of gingival inflammation also Probing Depth, Bleeding on Probing, and a Plaque Index will be accessed. Subjects will undergo baseline, 4-week, and 12-week evaluations, with data analyzed using ANCOVA to assess the efficacy and safety of the products. Adverse events and compliance will be closely monitored, with strict confidentiality maintained for all participants. The study rigorous design aims to provide comprehensive insights into the effectiveness of these oral hygiene regimens.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90010-150
      • Federal University of Rio Grande do Sul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Availability for the duration of the study;
• Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements, etc);
• Willingness to provide information related to their medical history;
• ≥20 teeth with scorable facial and lingual surfaces; evidence of gingivitis;
• ≥10 bleeding sites based on the BI
• Initial mean gingivitis index of at least 1.5 as determined by the use of the Modified Gingival Index (MGI).
• Subjects without allergies to the products that are being tested;
• Informed Consent Form signed.

Exclusion Criteria:

• That received dental prophylaxis within 1 month prior to the Baseline visit;
• Need for antibiotics prior to dental treatment; use of antibiotics, anti-inflammatory or anticoagulant therapy during the three months prior to entry into the study;
• Usage of oral care products containing chemotherapeutic products within 2 weeks prior to Baseline;
• Use of smokeless tobacco;
• Any other condition that would make the volunteer inappropriate for the study.
• Oral pathology, chronic disease, or a history of allergy to testing products;
• Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study;
• Subject participating in any other clinical study;
• Subject pregnant or breastfeeding;
• Subject allergic to oral care products, personal care consumer products, or their ingredients;
• Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine);
• Periodontal treatment 12 months before the beginning of the study;
• Current smokers and subjects with a history of alcohol or drug abuse;
• Subjects with orthodontic appliances or presence of fixed or removable prosthodontics dentures that may interfere with the evaluations

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CPC + Zn mouthwash + Brushing; A regimen composing a CPC + Zn mouthwash + Brushing with a fluoride toothpaste and a commercially available toothbrush	Drug: Mouthwash CPC+Zn+F; A mouthwash containing CPC + Zn and fluoride; Other Names: CPC+Zn; Drug: Toothpaste; A commercially available fluoride toothpaste; Device: Toothbrush; A commercially available adult toothbrush
Active Comparator: Essential oils mouthwash + Brushing; A regimen composing a essential oils mouthwash + Brushing with a fluoride toothpaste and a commercially available toothbrush	Drug: Toothpaste; A commercially available fluoride toothpaste; Device: Toothbrush; A commercially available adult toothbrush; Drug: Essential oils mouthrinse; Essential oils mouthrinse
Active Comparator: Flossing + Brushing; A regimen composing flossing + Brushing with a fluoride toothpaste and a commercially available toothbrush	Drug: Toothpaste; A commercially available fluoride toothpaste; Device: Toothbrush; A commercially available adult toothbrush; Device: Dental floss; Dental floss

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Gingival Index	The Modified Gingival Index (MGI) is a clinical assessment tool used to evaluate the severity of gingivitis by measuring the extent of gingival inflammation. It categorizes gingival health on a scale from 0 to 4, where 0 signifies normal gingiva with no inflammation, and 4 indicates severe inflammation characterized by erythema, edema, and spontaneous bleeding.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Turesky modification of Quigley-Hein Plaque Index	The Turesky modification of the Quigley-Hein Plaque Index is a method for assessing dental plaque accumulation by scoring plaque presence on six surfaces of each tooth on a scale from 0 to 5.	12 weeks
Bleeding on probing	Bleeding on probing (BOP) is a diagnostic technique used to assess gingival inflammation by gently probing the gum tissue; the presence of bleeding indicates inflammation and potential periodontal disease.	12 weeks
Probing depth	Probing depth measures the distance between the gingival margin and the bottom of the periodontal pocket using a calibrated periodontal probe, indicating the severity of periodontal disease.	12 weeks

Collaborators and Investigators

• Sponsor: Colgate Palmolive
• Collaborators: Federal University of Rio Grande do Sul
• Investigators: Principal Investigator: Cassiano K Rosing, PhD, Federal University of Rio Grande do Sul

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2024
• Primary Completion (Actual): December 9, 2024
• Study Completion (Actual): December 9, 2024

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 14, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: gingivitis; dental plaque
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Infections; Hemorrhage; Oral Hemorrhage; Periodontal Diseases; Gingivitis; Gingival Diseases; Gingival Hemorrhage
• Other Study ID Numbers: CRO-2024-08-PG-MWI-BZ-CB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No