Clinical and Microbiological Comparison of 0.2% CHX and 0.05% CHX+0.05%CPC Mouthwashes in TPS Patients

Periodontitis Clinical Trial

Official title:

Clinical and Microbiological Comparison Between 0.2% Chlorhexidine and 0.05% Chlorhexidine + 0.05% Cetylpyridinium Chloride Mouthwashes in Chemical Biofilm Control During Supportive Periodontal Therapy: A Randomized Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06411522
• Other study ID #: Perio_Micro_01
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: February 2025

Study information

• Verified date: May 2024
• Source: University of Siena
• Contact: Nicola Discepoli, DDS MSc PhD
• Phone: 3395256148
• Email: nicola.discepoli2[@]unisi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study compares the effectiveness of two mouthwash formulations (0.2% 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cetylpyridinium Chloride
• Chlorhexidine
• Gingivitis
• Periodontitis

Intervention

Device:
• 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).
• 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).

Locations

Country	Name	City	State
Italy	AOUS	Siena

Sponsors (1)

Lead Sponsor	Collaborator
University of Siena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Oral microbiota changes	The DNA from subgingival samples will be used to sequence the V3-V4 region of the 16S rRNA gene and will be analyzed using PCR (Polymerase Chain Reaction). The amplicons will be purified and sequenced.	The subgingival samples will be collected at the baseline visit, at 1, 2, and 3 months
Secondary	Blood Pressure	The systemic systolic and diastolic blood pressure (mmHg) will be measured in duplicate at each follow-up visit.	The systemic systolic and diastolic blood pressure will be measured at baseline, 1 month, 2 months, 3 months and 6 months.