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

NCT ID: NCT06607263

Last Updated: 2025-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-16
• Study Completion Date: 2024-12-09

Brief Summary

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.

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.

Conditions

Gingival Bleeding; Plaque Induced Gingival Disease; Gingivitis and Periodontal Diseases

Study Design

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

Study Groups

CPC + Zn mouthwash + Brushing

A regimen composing a CPC + Zn mouthwash + Brushing with a fluoride toothpaste and a commercially available toothbrush

Group Type: EXPERIMENTAL

Mouthwash CPC+Zn+F

Intervention Type: DRUG

A mouthwash containing CPC + Zn and fluoride

Toothpaste

Intervention Type: DRUG

A commercially available fluoride toothpaste

Toothbrush

Intervention Type: DEVICE

A commercially available adult toothbrush

Essential oils mouthwash + Brushing

A regimen composing a essential oils mouthwash + Brushing with a fluoride toothpaste and a commercially available toothbrush

Group Type: ACTIVE_COMPARATOR

Essential oils mouthrinse

Intervention Type: DRUG

Essential oils mouthrinse

Toothpaste

Intervention Type: DRUG

A commercially available fluoride toothpaste

Toothbrush

Intervention Type: DEVICE

A commercially available adult toothbrush

Flossing + Brushing

A regimen composing flossing + Brushing with a fluoride toothpaste and a commercially available toothbrush

Group Type: ACTIVE_COMPARATOR

Dental floss

Intervention Type: DEVICE

Dental floss

Toothpaste

Intervention Type: DRUG

A commercially available fluoride toothpaste

Toothbrush

Intervention Type: DEVICE

A commercially available adult toothbrush

Interventions

Mouthwash CPC+Zn+F

A mouthwash containing CPC + Zn and fluoride

Intervention Type: DRUG

Essential oils mouthrinse

Essential oils mouthrinse

Intervention Type: DRUG

Dental floss

Dental floss

Intervention Type: DEVICE

Toothpaste

A commercially available fluoride toothpaste

Intervention Type: DRUG

Toothbrush

A commercially available adult toothbrush

Intervention Type: DEVICE

Other Intervention Names

CPC+Zn

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Rio Grande do Sul

OTHER

Sponsor Role: collaborator

Colgate Palmolive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cassiano K Rosing, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Locations

Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

CRO-2024-08-PG-MWI-BZ-CB

Identifier Type: -

Identifier Source: org_study_id