A Randomized Controlled Clinical Trial Evaluating the Effectiveness of Ultrasonic Device in Impacted Mandibular Third Molar Surgery: Assessment Through Clinical Indices and Salivary C-reactive Protein Levels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Salivary hsCRP concentration
研究概览
简要总结
In the surgical removal of impacted mandibular third molars, ultrasonic surgical devices (piezosurgery) have been introduced with the expectation of reducing postoperative complications such as swelling, pain, and trismus, compared with conventional rotary instruments. To objectively evaluate the postoperative inflammatory response, salivary high-sensitivity C-reactive protein (hsCRP), a reliable biomarker of acute inflammation, will also be measured.
This randomized controlled clinical trial is designed to compare the effectiveness of ultrasonic surgery and conventional rotary instruments in impacted mandibular third molar extraction. The study has two primary objectives:
- To compare clinical outcomes, including swelling, mouth opening limitation, and pain, on postoperative days 2 and 5 between the two surgical methods.
- To assess changes in salivary hsCRP levels by comparing preoperative baseline values with postoperative day 2 values, and to determine differences between the two surgical techniques.
A total of 22 patients indicated for bilateral impacted mandibular third molar extractions of similar difficulty will be enrolled. Each patient will undergo one extraction using ultrasonic surgery and the contralateral extraction using rotary instruments, in a randomized split-mouth design.
Pain and swelling will be assessed on postoperative days 2 and 5. Saliva samples will be collected preoperatively and on postoperative day 2 for hsCRP analysis using enzyme-linked immunosorbent assay (ELISA).
The hypothesis is that ultrasonic surgery will result in reduced pain, swelling, and limitation of mouth opening, as well as lower salivary hsCRP levels, compared with conventional rotary instruments. Findings from this study may provide scientific evidence supporting the use of ultrasonic devices to improve patient outcomes and may highlight the role of salivary hsCRP as a non-invasive biomarker for monitoring inflammation after oral surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy patients (ASA Physical Status index ≤ 2), aged 18-35 years.
- •Patients presenting with bilateral impacted mandibular third molars of comparable difficulty, with the angulation difference between the two teeth not exceeding 15 degrees, as assessed according to the Pell and Gregory classification on panoramic radiographs.
- •Patients who agree to participate in the study after being fully informed about the objectives and requirements.
排除标准
- •Patients with acute systemic or oral infection at the surgical sites.
- •Patients with clinical evidence of tumors or cystic lesions, or radiolucent lesions larger than 3 mm on radiographs at the mandibular third molar site.
- •Patients with a history of antibiotic or anti-inflammatory drug use within 3 weeks prior to study participation.
- •Patients with psychiatric disorders, motor dysfunction, or trauma in the maxillofacial region.
- •Patients with systemic diseases or medication use that reduces salivary secretion, such as Sjögren's syndrome or prior head and neck radiotherapy.
- •Pregnant or breastfeeding women.
结局指标
主要结局
Salivary hsCRP concentration
时间窗: Preoperative (baseline) and day 2 after surgery
High-sensitivity C-reactive protein (hsCRP) levels in saliva measured by ELISA assay. Baseline value before surgery will be compared with postoperative Day 2 levels to assess inflammatory response between groups.
次要结局
- Postoperative pain(Day 2 and Day 5 post-surgery.)
- Postoperative swelling(Day 2 and Day 5 post-surgery)
- Mouth opening (trismus)(Day 2 and Day 5 post-surgery)
- Postoperative pain(Day 2 and Day 5 post-surgery.)
- Postoperative swelling(Day 2 and Day 5 post-surgery)
- Mouth opening (trismus)(Day 2 and Day 5 post-surgery)
研究者
Le Huynh Thien An
Lecturer, Department of Oral Surgery, Faculty of Dentistry
University of Medicine and Pharmacy at Ho Chi Minh City