Suture Materials, Third Molars Extraction
Conditions
Keywords
third molar, Cold Plasma, PTFE, Silk
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.
Interventions
PROCEDURESilk suture only
After third molar extraction, the surgical wound will be closed using silk sutures without plasma application.
PROCEDUREPTFE suture only
After third molar extraction, the surgical wound will be closed using PTFE sutures without plasma application.
PROCEDURESilk Suture + Cold athmospheric Plasma
After third molar extraction, silk sutures will be exposed to cold atmospheric plasma before being used for wound closure.
PROCEDUREPTFE Suture + Cold athmospheric Plasma
After third molar extraction, the surgical wound will be closed using PTFE sutures without plasma application.
PROCEDURESilk Suture + Cold athmospheric argon Plasma
After third molar extraction, silk sutures will be exposed to cold atmospheric argon plasma before being used for wound closure.
PROCEDUREPTFE Suture + Cold athmospheric argon Plasma
After third molar extraction, PTFE sutures will be exposed to cold atmospheric argon plasma before being used for wound closure.
Sponsors
Izzet Acikan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* at least 18 years old and had no acute pericoronal infection
Exclusion criteria
* Individuals with systemic con-ditions such as diabetes mellitus, immunodeficiency, bleeding disorders, dyspepsia, or those classified as heavy smokers (over 10 cigarettes daily)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Assessment | Preoperative 20 minutes before local anesthesia administration, 1st. day, 2nd. day, 3rd. day, 4th. day, 5th. day, 6th. day, 7th. day. | The patients' pain levels were evaluated using a 10-unit Visual Analog Scale (VAS). The patients were given a form on which they could mark the pain they felt as a score between 0 (no pain) and 10 (the most severe pain) at the following time points: 20 minutes before local anesthesia administration, and on postoperative day 1, day 2, day 3, day 4, day 5, day 6, and day 7. After completing these forms, the patients returned them at the end of the 7th day. |
| Facial Swelling Assessment | prior to surgery, on the second postoperative day, and on the seventh postoperative day | Facial swelling was assessed by performing three-dimensional (3D) facial scans at three different time points: prior to surgery (T0), on the second postoperative day (T1), and on the seventh postoperative day (T2). All scans were obtained in the same clinical room under consistent lighting conditions. For image acquisition, the Qlone appli-cation (EyeCue Vision Technologies LTD.), compatible with iOS devices (iPhone 14, Apple Inc., CA, USA), was utilized, offering a guided face-scanning process. Upon completion, each scan was converted into an STL file, which was subsequently transferred to the 3D Slicer software. The paired scans were then superimposed, and volumetric differences were calculated. |
| Mouth Opening Assessment | prior to the operation, on the second postoperative day, and on the seventh postoperative day | Interincisal mouth opening was measured both before and after surgery using a standard monoblock caliper. During the assessment, participants were seated upright with the orbitomeatal plane aligned parallel to the ground. The maximum unassisted midline in-terincisal distance was recorded in millimeters (mm) at three time points. |
| Quality of life Assessment | preoperatively, 2nd, and 7th days | Quality of life was evaluated before and after surgery using the OHIP-14 questionnaire. Postoperative assessments were carried out on the preoperatively, 2nd, and 7th days following the procedure. Each question was rated on a 4-point scale: 1 = never, 2 = sometimes, 3 = fairly often, and 4 = very often. The possible total score ranged from 0 to 56, with higher scores reflecting greater impairment in quality of life. |
Countries
Turkey (Türkiye)
Outcome results
None listed