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
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Italy
AOUS
RECRUITING
Siena
Contact Information
Primary
Nicola Discepoli, DDS MSc PhD
nicola.discepoli2@unisi.it
3395256148
Time Frame
Start Date: 2024-05-20
Estimated Completion Date: 2025-09
Participants
Target number of participants: 72
Treatments
Active_comparator: Treatment Test 1
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.
Experimental: Treatment Test 2
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.
Related Therapeutic Areas
Sponsors
Leads: University of Siena