Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2025-12-18 @ 7:18 AM
Study NCT ID:
NCT06411522
Status:
None
Last Update Posted:
2025-11-24 00:00:00
First Post:
2024-05-01 00:00:00
Brief Title:
Clinical and Microbiological Comparison of 0.12% CHX and 0.05% CHX+0.05%CPC Mouthwashes in TPS Patients
Sponsor:
University of Siena
Organization:
University of Siena
Study Overview
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
Status:
None
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
This study aims to assess the impact of at-home use of 005 CPC 005 chlorhexidine or 012 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 012 chlorhexidine with the alternative formulation of 005 chlorhexidine 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None