Clinical and Microbiological Comparison of 0.12% CHX and 0.05% CHX+0.05%CPC Mouthwashes in TPS Patients

NCT ID: NCT06411522

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-20
• Study Completion Date: 2025-10-18

Brief Summary

The present study compares the effectiveness of two mouthwash formulations (0.12% CHX and 0.05% CHX+0.05%CPC) in reducing gingival inflammation and microbial colonization in individuals with gingivitis and in preventing periodontitis recurrence. The main focus is on assessing the clinical impact of the mouthwashes over six months, with a secondary goal of evaluating their effect on systemic blood pressure.

Detailed Description

This study aims to assess the impact of at-home use of 0.05% CPC + 0.05% chlorhexidine or 0.12% chlorhexidine, combined with professional plaque removal, on gingival inflammation and microbial quantity and quality in individuals diagnosed with gingivitis and reduced periodontium. It seeks to identify the most effective mouthwash formulation for reducing microbial colonization and preventing periodontitis recurrence. Comparing the commonly used 0.12% chlorhexidine with the alternative formulation of 0.05% chlorhexidine + 0.05% CPC over one month, with no reported side effects, is the main focus. The study does not pose risks to participants, with the main inconvenience being tooth enamel darkening, which can be easily resolved with professional dental cleaning. The primary objective is to evaluate the additional clinical effect of both formulations after professional plaque removal over six months in patients undergoing supportive periodontal therapy. The secondary objective is to assess the impact of these antimicrobials on systemic blood pressure.

Conditions

Chlorhexidine; Gingivitis; Periodontitis; Cetylpyridinium Chloride

Study Design

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

Study Groups

Treatment Test 1

Following the completion of a comprehensive periodontal charting, and prior to assigning the patient to one of the two experimental groups, patients will undergo an Oral Hygiene Instruction and Motivation (OHIM) session using a manual toothbrush, individualized interdental brushes, and a commercially available toothpaste containing sodium fluoride. Subsequently, a professional mechanical plaque removal (PMPR) will be performed by the operator, consisting of a conventional dental hygiene session.

In treatment Test 1 patients will receive mouthwash containing 0.12% CHX (Chlorhexidine). Each patient will be instructed to use the assigned mouthwash twice a day (15 ml for 30 s) after common practices of home oral hygiene. Follow-up visits will occur at 1, 2, 3, and 6 months, during which participants will be clinically examined. Microbiological samples will be collected at 1, 2, and 3 months.

Group Type: ACTIVE_COMPARATOR

Mouthwash containing 0.12% CHX (Chlorhexidine)

Intervention Type: DEVICE

Following the execution of a full mouth periodontal chart, the delivery of oral hygiene instructions and motivation and a session of full mouth ultrasonic debridement, patients, according to the allocation group, will receive a 0.2% CHX mouthwash. Patients will be instructed to use the delivered mouthwashes twice a day (15 ml for 30 seconds).

Treatment Test 2

After completing a thorough periodontal charting and before allocating patients to one of the two experimental groups, they will receive an Oral Hygiene Instruction and Motivation (OHIM) session using a manual toothbrush, personalized interdental brushes, and a commercially available toothpaste containing sodium fluoride. Following this, an operator will conduct a professional mechanical plaque removal (PMPR), which entails a standard dental hygiene procedure.

In Treatment Test 2 patients will receive mouthwash containing 0.05% CHX (Chlorhexidine) and 0.05% CPC (Cetylpyridinium Chloride) as the main active ingredients in a patented formulation with optimized bioavailability and they will be instructed to use it twice daily (15 ml for 30 s) following their regular home oral hygiene routine.

Follow-up appointments will be scheduled at 1, 2, 3, and 6 months for clinical examinations of participants, with microbiological samples being collected at 1, 2, and 3 months.

Group Type: EXPERIMENTAL

Mouthwash containing 0.05% CHX (Chlorhexidine) and 0.05% CPC (Cetylpyridinium Chloride)

Intervention Type: DEVICE

Following the execution of a full mouth periodontal chart, the delivery of oral hygiene instructions and motivation and a session of full mouth ultrasonic debridement, patients, according to the allocation group, will receive a 0.05% CHX + 0.05% CPC mouthwash. Patients will be instructed to use the delivered mouthwashes twice a day (15 ml for 30 seconds).

Interventions

Mouthwash containing 0.12% CHX (Chlorhexidine)

Following the execution of a full mouth periodontal chart, the delivery of oral hygiene instructions and motivation and a session of full mouth ultrasonic debridement, patients, according to the allocation group, will receive a 0.2% CHX mouthwash. Patients will be instructed to use the delivered mouthwashes twice a day (15 ml for 30 seconds).

Intervention Type: DEVICE

Mouthwash containing 0.05% CHX (Chlorhexidine) and 0.05% CPC (Cetylpyridinium Chloride)

Following the execution of a full mouth periodontal chart, the delivery of oral hygiene instructions and motivation and a session of full mouth ultrasonic debridement, patients, according to the allocation group, will receive a 0.05% CHX + 0.05% CPC mouthwash. Patients will be instructed to use the delivered mouthwashes twice a day (15 ml for 30 seconds).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Bleeding on probing (BOP) ≥10%,
• No more than 4 sites with pocket depth (PPD) >5mm
• Presence of attachment loss (AL) and radiographic bone loss (RBL)
• A minimum of 20 teeth

Exclusion Criteria

• Intolerance or allergy to antimicrobials
• Systemic therapy with anticoagulants/beta-blockers
• Local/systemic antibiotic therapy 3 months before
• Inability to understand and sign the written informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Siena

OTHER

Sponsor Role: lead

Responsible Party

Nicola Discepoli

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicola Discepoli, DDS MSc PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Biotechnologies, University of Siena

Locations

AOUS

Siena, , Italy

Countries

Italy

Other Identifiers

Perio_Micro_01

Identifier Type: -

Identifier Source: org_study_id