Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371027
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2024-04-15
Brief Title:
Novel Silk Fibroin Nanofiber Membrane Using Minimally Invasive Surgery in Treatment of Periodontal Intrabony Defects A Randomized Clinical Trial
Sponsor:
October 6 University
Organization:
October 6 University
Study Overview
Official Title:
Novel Silk Fibroin Nanofiber Membrane Using Minimally Invasive Surgery in Treatment of Periodontal Intrabony Defects A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-04
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:
Clinically and radiographically by cone beam CT evaluate the regenerative potentials of silk fibroin SF nanofiber membrane using minimally invasive surgery for the regenerative treatment of intrabony periodontal defects
Detailed Description:
Periodontitis is a bacterially induced chronic inflammation of the periodontium that extends beyond the gingiva and involves progressive and irreversible destruction of the connective tissue attachment of the teethThe treatment involves debridement of the tooth surface and the adjacent areas employing scaling root planing and periodontal flap surgery While scaling and root planing are non-surgical treatment modalities and are conservative periodontal flap surgery gains access to the underlying bone for complete debridement achieving pocket depth reduction periodontal regeneration and maintenance of periodontium in healthy condition feasible by routine home care methods by the patient
Guided tissue regeneration GTR therapy is playing a key role in the management of intrabony defects Current resorbable and non-resorbable membranes act as a physical barrier to avoid connective and epithelial tissue down-growth into the defect favoring the regeneration of periodontal tissues However these conventional membranes possess many structural mechanical and bio-functional limitations and the ideal membrane for use in periodontal regenerative therapy has yet to be developed Based on a graded-biomaterials approach we have hypothesized that a biologically active and spatially designed and functionally graded nanofibrous material that mimics closely the native extracellular matrix ECM could succeed as the next generation of GTR membranes for periodontal tissue engineering In the current study using a minimally invasive surgical approach we will compare a novel silk fibroin SF nanofiber membrane to collagen membrane as a regenerative treatment of intrabony periodontal defects
Guided tissue regeneration GTR therapy is playing a key role in the management of intrabony defects Current resorbable and non-resorbable membranes act as a physical barrier to avoid connective and epithelial tissue down-growth into the defect favoring the regeneration of periodontal tissues However these conventional membranes possess many structural mechanical and bio-functional limitations and the ideal membrane for use in periodontal regenerative therapy has yet to be developed Based on a graded-biomaterials approach we have hypothesized that a biologically active and spatially designed and functionally graded nanofibrous material that mimics closely the native extracellular matrix ECM could succeed as the next generation of GTR membranes for periodontal tissue engineering In the current study using a minimally invasive surgical approach we will compare a novel silk fibroin SF nanofiber membrane to collagen membrane as a regenerative treatment of intrabony periodontal defects
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