Comparative Study to Evaluate the Efficacy of an Alcohol-free Mouthwash Regimen With CPC+Zn, Flossing and Brushing, and an Alcohol-based Mouthwash Regimen With Essential Oils in Reducing Plaque and Gingivitis.

NCT ID: NCT06598072

Last Updated: 2025-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-17
• Study Completion Date: 2024-12-16

Brief Summary

This is a Phase III, randomized, one-center, parallel group, double blinded, clinical study to evaluate the efficacy of 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. One hundred and twenty participants, aged between 18 and 65 years, will be included and followed for 12 weeks.

Detailed Description

This clinical study aims to evaluate the efficacy of a regimen including an alcohol-free mouthwash containing CPC+Zn as compared to dental flossing and brushing and to a regimen including a rinsing with an essential oils containing alcohol mouthwash in reducing dental plaque and gingivitis. This is a Phase III, randomized, one-center, parallel group, double blinded, involving 120 participants, aged 18 to 65. Subjects will be allocated into 3 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; Gingival Diseases; Gingivitis and Periodontal Diseases

Study Design

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

Study Groups

CPC+Zn mouthwash and brushing

A regimen composing of a CPC+Zn mouthwash, brushing with a commercially available toothbrush and a stannous fluoride-based toothpaste

Group Type: EXPERIMENTAL

Mouthwash CPC+Zn+F

Intervention Type: DRUG

A mouthwash containing CPC + Zn and fluoride

Essential oils mouthwash and brushing

A regimen composing of an essential oils mouthwash, brushing with a commercially available toothbrush and a fluoride-based toothpaste

Group Type: ACTIVE_COMPARATOR

Essential oils mouthwash

Intervention Type: DRUG

Essential oils mouthwash

Flossing and brushing

A regimen composing of flossing and brushing with a commercially available toothbrush and a fluoride-based toothpaste

Group Type: ACTIVE_COMPARATOR

Dental floss

Intervention Type: DEVICE

Dental Floss

Interventions

Mouthwash CPC+Zn+F

A mouthwash containing CPC + Zn and fluoride

Intervention Type: DRUG

Essential oils mouthwash

Essential oils mouthwash

Intervention Type: DRUG

Dental floss

Dental Floss

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; At least 20 teeth with scorable facial and lingual surfaces; evidence of gingivitis; At least 10 bleeding sites based on the Bleeding Index (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

No sites with more than 5 mm probing depth, and a maximum of three sites of 5 mm probing depth.

Have 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

Universidad Autonoma de San Luis Potosí

OTHER

Sponsor Role: collaborator

Colgate Palmolive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universidad Autónoma de San Luis Potosí

San Luis Potosí City, San Luis Potosí, Mexico

Countries

Mexico

Other Identifiers

CRO-2024-08-PG-MWII-MX-CB

Identifier Type: -

Identifier Source: org_study_id