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

NCT06607263 | Completed Phase 3 DMC

• 1 other identifier: CRO-2024-08-PG-MWI-BZ-CB
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

dental plaque; gingivitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Turesky modification of Quigley-Hein Plaque Index

  12 weeks

• Bleeding on probing

  12 weeks

• Probing depth

  12 weeks

Study Arms (3)

CPC + Zn mouthwash + Brushing

EXPERIMENTAL

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

Drug: Mouthwash CPC+Zn+F; Drug: Toothpaste; Device: Toothbrush

Essential oils mouthwash + Brushing

ACTIVE COMPARATOR

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

Drug: Essential oils mouthrinse; Drug: Toothpaste; Device: Toothbrush

Flossing + Brushing

ACTIVE COMPARATOR

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

Device: Dental floss; Drug: Toothpaste; Device: Toothbrush

Interventions

Mouthwash CPC+Zn+F DRUG

A mouthwash containing CPC + Zn and fluoride

Also known as: CPC+Zn

CPC + Zn mouthwash + Brushing

Essential oils mouthrinse DRUG

Essential oils mouthrinse

Essential oils mouthwash + Brushing

Dental floss DEVICE

Dental floss

Flossing + Brushing

Toothpaste DRUG

A commercially available fluoride toothpaste

CPC + Zn mouthwash + Brushing; Essential oils mouthwash + Brushing; Flossing + Brushing

Toothbrush DEVICE

A commercially available adult toothbrush

CPC + Zn mouthwash + Brushing; Essential oils mouthwash + Brushing; Flossing + Brushing

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Colgate Palmolive: lead
• Federal University of Rio Grande do Sul: collaborator

Study Sites (1)

Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90010-150, Brazil

Location

MeSH Terms

Conditions

Gingival Hemorrhage; Gingivitis; Periodontal Diseases; Dental Plaque

Interventions

Dental Devices, Home Care; Toothpastes

Condition Hierarchy (Ancestors)

Oral Hemorrhage; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Dental Deposits; Tooth Diseases

Intervention Hierarchy (Ancestors)

Dental Equipment; Dentistry; Oral Hygiene; Preventive Dentistry; Equipment and Supplies; Dentifrices; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Cassiano K Rosing, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this clinical trial, masking involves several key roles to ensure unbiased results. The Participant, Care Provider, Investigator, and Outcomes Assessor are all masked in this double-blind study. This means that the participants do not know which group they have been assigned to, the care providers administering the treatments are unaware of the specific products being used by each participant, the investigators conducting the study do not know the group assignments, and the outcomes assessors evaluating the results are blind to the treatment allocations. This comprehensive masking approach is designed to minimize any potential biases and maintain the integrity of the study results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase III, randomized, controlled, double-blind, parallel-group clinical trial

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 23, 2024
• Study Start: September 16, 2024
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: April 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)