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.

NCT06598072 | Completed Phase 3 DMC

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

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.

Conditions

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

Keywords

gingivitis; dental plaque

Outcome Measures

Primary Outcomes (1)

• Modified Gingival Index

  The Modified Gingival Index (MGI) is used to evaluate the severity of gingivitis by measuring the extent of gingival inflammation. It categorizes gingival health/inflammation 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 and brushing

EXPERIMENTAL

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

Drug: Mouthwash CPC+Zn+F

Essential oils mouthwash and brushing

ACTIVE COMPARATOR

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

Drug: Essential oils mouthwash

Flossing and brushing

ACTIVE COMPARATOR

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

Device: Dental floss

Interventions

Mouthwash CPC+Zn+F DRUG

A mouthwash containing CPC + Zn and fluoride

Also known as: CPC+Zn

CPC+Zn mouthwash and brushing

Essential oils mouthwash DRUG

Essential oils mouthwash

Essential oils mouthwash and brushing

Dental floss DEVICE

Dental Floss

Flossing and 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; 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Colgate Palmolive: lead
• Universidad Autonoma de San Luis Potosí: collaborator

Study Sites (1)

Universidad Autónoma de San Luis Potosí

San Luis Potosí City, San Luis Potosí, 78000, Mexico

Location

MeSH Terms

Conditions

Gingival Hemorrhage; Gingival Diseases; Gingivitis; Periodontal Diseases; Dental Plaque

Interventions

Dental Devices, Home Care

Condition Hierarchy (Ancestors)

Oral Hemorrhage; Mouth Diseases; Stomatognathic 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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking involves several key roles to ensure unbiased results and to maintain the integrity of the study results. The Participant, Care Provider, Investigator, and Outcomes Assessor are all masked in this double-blind study. 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.
• 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 19, 2024
• Study Start: September 17, 2024
• Primary Completion: December 16, 2024
• Study Completion: December 16, 2024
• Last Updated: April 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)