Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522438
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Hyaluronic Acid and Octenidine Gel as an Adjunct to Non-surgical Periodontal Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Early Healing Dynamics and Microbial Changes Following the Use of a Novel Thermosensitive Gel With Hyaluronic Acid and Octenidine as an Adjunct to Non-surgical Periodontal Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This parallel-group pilot study will test the hypothesis that the adjunctive use of a thermosensitive gel containing Hyaluronic Acid HA and Octenidine to non-surgical periodontal treatment NSPT will be able to modulate the early wound healing events This will be assessed through the expression of specific gingival crevicular fluid markers as well as by changes in gingival blood flow assessed by laser speckle contrast imaging bacterial load soft tissues contour clinical parameters and patient-reported outcomes
The study will involve up to 26 patients and will take place at the Centre for Oral Clinical Research COCR at the Institute of Dentistry Faculty of Medicine and Dentistry Queen Mary University of London under The Royal London Dental Hospital Barts Health NHS Trust Patients will be randomised to receive either NSPT alone or NSPT HA and Octenidine gel and will be followed up to 3 months after treatment
The study will consist of 7- 8 visits
The study will involve up to 26 patients and will take place at the Centre for Oral Clinical Research COCR at the Institute of Dentistry Faculty of Medicine and Dentistry Queen Mary University of London under The Royal London Dental Hospital Barts Health NHS Trust Patients will be randomised to receive either NSPT alone or NSPT HA and Octenidine gel and will be followed up to 3 months after treatment
The study will consist of 7- 8 visits
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None