Clinical trial NCT06411522: Clinical and Microbiological Comparison of 0.12% CHX and 0.05% CHX+0.05%CPC Mouthwashes in TPS Patients
Official title: Clinical and Microbiological Comparison Between 0.12% Chlorhexidine and 0.05% Chlorhexidine + 0.05% Cetylpyridinium Chloride Mouthwashes in Chemical Biofilm Control During Supportive Periodontal Therapy: A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chlorhexidine
Gingivitis
Periodontitis
Cetylpyridinium Chloride
Keywords: Prevention
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of sites with Bleeding on Probing
timeFrame: 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:
measure: Oral microbiota changes
timeFrame: The subgingival samples will be collected at the baseline visit, at 1, 2, and 3 months
measure: Blood Pressure
timeFrame: The systemic systolic and diastolic blood pressure will be measured at baseline, 1 month, 2 months, 3 months and 6 months.
Other outcomes:
Locations:
city: Siena
country: Italy
facility: AOUS
Study officials:
affiliation: Department of Medical Biotechnologies, University of Siena
name: Nicola Discepoli, DDS MSc PhD
role: PRINCIPAL_INVESTIGATOR
References: