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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative Pain Assessment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 18 years old and had no acute pericoronal infection
排除标准
- •Individuals with systemic con-ditions such as diabetes mellitus, immunodeficiency, bleeding disorders, dyspepsia, or those classified as heavy smokers (over 10 cigarettes daily)
研究组 & 干预措施
silk suture only
The group in which only silk sutures will be used for wound closure after third molar extraction.
干预措施: Silk suture only (Procedure)
PTFE suture only
The group in which only PTFE sutures will be used for wound closure after third molar extraction.
干预措施: PTFE suture only (Procedure)
silk suture and CAP
The group in which cold atmospheric plasma is applied to silk sutures before wound closure with silk sutures after third molar extraction.
干预措施: Silk Suture + Cold athmospheric Plasma (Procedure)
PTFE suture and CAP
The group in which cold atmospheric plasma is applied to PTFE sutures before wound closure with PTFE sutures after third molar extraction.
干预措施: PTFE Suture + Cold athmospheric Plasma (Procedure)
silk suture and CAP-Ar
The group in which cold atmospheric argon plasma is applied to silk sutures before wound closure with silk sutures after third molar extraction.
干预措施: Silk Suture + Cold athmospheric argon Plasma (Procedure)
PTFE suture and CAP-Ar
The group in which cold atmospheric argon plasma is applied to PTFE sutures before wound closure with PTFE sutures after third molar extraction.
干预措施: PTFE Suture + Cold athmospheric argon Plasma (Procedure)
结局指标
主要结局
Postoperative Pain Assessment
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Izzet Acikan
Assistant Professor
Kahramanmaras Sutcu Imam University