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

NCT06411522 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-11-24

No results posted yet for this 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.

Conditions

  • Chlorhexidine
  • Gingivitis
  • Periodontitis
  • Cetylpyridinium Chloride

Interventions

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).

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).

Sponsors & Collaborators

  • University of Siena

    lead OTHER

Principal Investigators

  • Nicola Discepoli, DDS MSc PhD · Department of Medical Biotechnologies, University of Siena

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-20
Primary Completion
2025-10-18
Completion
2025-10-18

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06411522 on ClinicalTrials.gov