Clinical Trials Directory

Trials / Completed

CompletedNCT07175818

Cold Plasma-Treated Sutures in Third Molar Surgery: Effects on Outcomes

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
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Izzet Acikan · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURESilk suture onlyAfter third molar extraction, the surgical wound will be closed using silk sutures without plasma application.
PROCEDUREPTFE suture onlyAfter third molar extraction, the surgical wound will be closed using PTFE sutures without plasma application.
PROCEDURESilk Suture + Cold athmospheric PlasmaAfter third molar extraction, silk sutures will be exposed to cold atmospheric plasma before being used for wound closure.
PROCEDUREPTFE Suture + Cold athmospheric PlasmaAfter third molar extraction, the surgical wound will be closed using PTFE sutures without plasma application.
PROCEDURESilk Suture + Cold athmospheric argon PlasmaAfter third molar extraction, silk sutures will be exposed to cold atmospheric argon plasma before being used for wound closure.
PROCEDUREPTFE Suture + Cold athmospheric argon PlasmaAfter third molar extraction, PTFE sutures will be exposed to cold atmospheric argon plasma before being used for wound closure.

Timeline

Start date
2025-03-24
Primary completion
2025-05-30
Completion
2025-06-06
First posted
2025-09-16
Last updated
2025-09-16

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07175818. Inclusion in this directory is not an endorsement.