Effects of Impacted Mandibular Third Molar Surgery Performed With Piezoelectric and Conventional Rotary Systems on Postoperative 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
- 50
- 试验地点
- 1
- 主要终点
- mouth opening measurement
研究概览
简要总结
This study is a prospective, randomized clinical trial comparing recovery after the surgical removal of impacted lower wisdom teeth. The aim is to evaluate swelling, pain, mouth opening, and quality of life after surgery.
The study was approved by the Ethics Committee of Harran University, and all patients gave written informed consent. It was conducted at the Faculty of Dentistry, Kahramanmaraş Sütçü İmam University. A total of 50 patients participated. They were randomly assigned to two groups: one treated with a piezoelectric device (study group) and the other with a conventional rotary handpiece (control group). All surgeries were performed by the same surgeon under local anesthesia.
In both groups, the tooth was removed, the bone edges were smoothed, the area was cleaned with sterile solution, and the gum flap was closed with stitches. In the piezoelectric group, the bone was removed using an ultrasonic piezoelectric system. In the conventional group, bone removal was performed with a surgical drill under irrigation.
After surgery, patients were followed for pain, swelling, mouth opening, and quality of life. Pain was measured daily for 7 days using a 10-point visual scale (0 = no pain, 10 = worst pain). Mouth opening was measured before surgery, on the 2nd day, and on the 7th day after surgery. Swelling was measured using 3-dimensional facial scans taken before surgery, and on the 2nd and 7th days after surgery. Quality of life was assessed with a short questionnaire (OHIP-14), completed before surgery and on days 2, and 7 after surgery. Higher scores meant a worse impact on daily life.
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
- •Inclusion criteria were being over 18 years of age,
- •having an indication for impacted third molar extraction in the mandible,
- •absence of acute pericoronitis or any other active infection,
- •willingness to participate in the study.
排除标准
- •Individuals with systemic conditions such as
- •diabetes mellitus,
- •immunodeficiency,
- •bleeding disorders,
- •dyspepsia or
- •those classified as heavy smokers (over 10 cigarettes daily)
结局指标
主要结局
mouth opening measurement
时间窗: Maximum mouth opening measurements were performed at three different time points: before surgery, on the 2nd postoperative day, and on the 7th postoperative day, and were recorded in millimeters.
Pain Assessment
时间窗: Preoperative 20 minutes before local anesthesia administration, postoperative day 1, day 2, day 3, day 4, day 5, day 6, and day 7.
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.
swelling measurement
时间窗: For the measurement of swelling, each patient underwent three-dimensional facial scanning at three time points: immediately before surgery (T0), on the 2nd postoperative day (T1), and on the 7th postoperative day (T2).
To objectively evaluate postoperative facial swelling, a 3D facial scanning method was employed. All facial scans were performed in the same room, with a standardized position and similar lighting conditions. To obtain three-dimensional facial images, the Qlone application (EyeCue Vision Technologies LTD.) running on an iPhone 14 device equipped with TrueDepth technology was used. This smartphone-based application provides a guided scanning procedure that enables a rapid and detailed capture of the patient's face. At the end of each scanning session, an STL file representing the patient's facial structure was generated. The obtained STL-format facial models were imported into the 3D imaging software 3D Slicer. T0 and T1/T2 facial scans were superimposed within 3D Slicer to detect changes occurring in the facial surface. The superimposition process was carried out using surface registration, referencing stable anatomical regions of the face.
Quality of Life Assessment
时间窗: Oral health-related quality of life was evaluated using the OHIP-14. Participants completed the questionnaire preoperatively, and on postoperative days 2 and 7.
Quality of life was evaluated before and after surgery using the OHIP-14 questionnaire. The OHIP-14 assessment was performed preoperatively, and on postoperative days 2 and 7. 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