Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06296498
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-28
Brief Title:
Application of L-PRF in Periodontal Surgery
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
The Effect of Application of L-PRF in Periodontal Surgery on Clinical Parameters and Patient Related Outcome Measures A Randomized Controlled Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-02
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:
The study will compare the clinical outcomes of the two procedures open flap debridement OFD compared to open flap debridement with leukocyte and platelet-rich fibrin L-PFR as well as differences in patient postoperative pain perception
Detailed Description:
Randomization to one of two standard of care procedures
1 Test group After gingival flap reflection and debridement of bone and root surfaces L-PRF will be applied to the alveolar bone tooth roots and gingival flap prior to suturing
2 Control group Standard of care Gingival flap reflection and debridement of bone and root surfaces followed by suturing of the gingival flaps
The study is a split-mouth design randomized prospective clinical trial The protocol will randomize gingival quadrants in subjects to one of two standard of care procedures OFD or OFD L-PRF Patients needing periodontal surgery to correct periodontal disease will be enrolled There will be two subject groups in this study Each subject will be randomized to one of the treatments for the first quadrant and the contralateral quadrant will receive the other treatment No risk is expected from being assigned to either group as both procedures are standard of care with possible benefit of enhanced wound healing and bone regeneration in the test group
Allocation of subjects into test group or control group will be based on numbers drawn from a stack of sealed envelopes
1 Test group After gingival flap reflection and debridement of bone and root surfaces L-PRF will be applied to the alveolar bone tooth roots and gingival flap prior to suturing
2 Control group Standard of care Gingival flap reflection and debridement of bone and root surfaces followed by suturing of the gingival flaps
The study is a split-mouth design randomized prospective clinical trial The protocol will randomize gingival quadrants in subjects to one of two standard of care procedures OFD or OFD L-PRF Patients needing periodontal surgery to correct periodontal disease will be enrolled There will be two subject groups in this study Each subject will be randomized to one of the treatments for the first quadrant and the contralateral quadrant will receive the other treatment No risk is expected from being assigned to either group as both procedures are standard of care with possible benefit of enhanced wound healing and bone regeneration in the test group
Allocation of subjects into test group or control group will be based on numbers drawn from a stack of sealed envelopes
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