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

NCT06411522 | Completed

• 1 other identifier: Perio_Micro_01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Chlorhexidine; Gingivitis; Periodontitis; Cetylpyridinium Chloride

Keywords

Prevention

Outcome Measures

Primary Outcomes (1)

• Number of sites with Bleeding on Probing

  Evaluate the additional effect on bleeding on probing of one month application of 0.12% CHX or 0.05% CHX + 0.05% CPC following a professional mechanical plaque removal (PMPR) session for a clinical evaluation period of 6 months in patients undergoing supportive periodontal therapy (gingivitis with reduced periodontium).

  Bleeding on Probing (BOP) will be recorded by a calibrated and blinded examiner at the baseline visit and at one, two, three, and six months after treatment.

Secondary Outcomes (2)

• Oral microbiota changes

  The subgingival samples will be collected at the baseline visit, at 1, 2, and 3 months

• Blood Pressure

  The systemic systolic and diastolic blood pressure will be measured at baseline, 1 month, 2 months, 3 months and 6 months.

Study Arms (2)

Treatment Test 1

ACTIVE COMPARATOR

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.

Device: Mouthwash containing 0.12% CHX (Chlorhexidine)

Treatment Test 2

EXPERIMENTAL

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.

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

Interventions

Mouthwash containing 0.12% CHX (Chlorhexidine) 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 1

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

Treatment Test 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Siena: lead

Study Sites (1)

AOUS

Siena, 53100, Italy

Location

MeSH Terms

Conditions

Gingivitis; Periodontitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Nicola Discepoli, DDS MSc PhD

  Department of Medical Biotechnologies, University of Siena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 13, 2024
• Study Start: May 20, 2024
• Primary Completion: October 18, 2025
• Study Completion: October 18, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

IT (1)