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

Last updated: November 21, 2025
Sponsor: University of Siena
Overall Status: Completed

Phase

N/A

Condition

Periodontitis

Treatment

Mouthwash containing 0.12% CHX (Chlorhexidine)

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

Clinical Study ID

NCT06411522
Perio_Micro_01
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: Mouthwash containing 0.12% CHX (Chlorhexidine)
Phase:
Study Start date:
May 20, 2024
Estimated Completion Date:
October 18, 2025

Study 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.

Connect with a study center

  • AOUS

    Siena, 53100
    Italy

    Site Not Available

  • AOUS

    Siena 3166548, 53100
    Italy

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.