Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-06-11 @ 10:15 AM
Study NCT ID:
NCT07175818
Status:
COMPLETED
Last Update Posted:
2025-09-16
First Post:
2025-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cold Plasma-Treated Sutures in Third Molar Surgery: Effects on Outcomes
Sponsor:
Izzet Acikan
Organization:
Study Overview
Official Title:
Effects of Cold Plasma Systems Applied to PTFE and Silk Su-tures Used in Impacted Lower Third Molar Surgery on Post-operative Sequelae and Quality of Life
Status:
COMPLETED
Status Verified Date:
2025-09
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 compare the effectiveness of two types of surgical suture materials, silk and polytetrafluoroethylene (PTFE), used alone and in combination with cold atmospheric plasma systems, on postoperative outcomes such as pain, facial swelling, and limitation of mouth opening following mandibular third molar surgery. Written informed consent will be obtained from all volunteers prior to participation. For all groups, the surgical procedures will be performed on an outpatient basis under local anesthesia (2% lidocaine with 1:100,000 epinephrine) by a single surgeon. After achieving deep local anesthesia by blocking the inferior alveolar, buccal, and lingual nerves, the incision will be made using a modified envelope flap. Bone osteotomy will be performed under copious irrigation with sterile saline, using a high-speed straight surgical handpiece (20,000-40,000 rpm) and a #10 surgical round bur. After successful extraction of the teeth, bone margins will be appropriately smoothed, and the surgical site will be irrigated thoroughly with saline. The mucoperiosteal flap will then be closed with sutures according to the group criteria. For groups assigned to plasma application, plasma will be applied to the surface of the sutures. Pre- and postoperative evaluations will be conducted for all patients regarding facial swelling, limitation of mouth opening, and pain, using the same techniques. Assessment of swelling and mouth opening limitation will also be performed by the surgeon. Quality of life will be evaluated preoperatively and postoperatively for all participants. Follow-up examinations will be performed preoperatively, on the 2nd postoperative day, and on the 7th postoperative day. At these time points, facial scans will be recorded using the Qlone application on an iPhone 14, and STL files will be generated.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: