The Effect of Saline Irrigation at Different Temperatures on Pain, Edema, and Trismus After Impacted Third Molar Surgery: A Prospective, Randomized, Split-Mouth, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in Facial Swelling
研究概览
简要总结
Third molar surgery is one of the most common procedures in oral surgery and the most common postoperative complications are swelling, pain, and trismus. This study aims to evaluate the postoperative morbidity (pain, swelling, and trismus) in third molar surgery performed using different degrees of cooled and room temperature irrigation solutions.
详细描述
This single-blind, single- centre, split-mouth, superiority randomized prospective clinical trial was approved by The Ethics Committee of Trakya University, Medical Sciences (Decision no: 13/10). The sample size calculation based on data obtained from a previous study indicated that 48 patients would be sufficient per group (80% power and 5% significance level).
Adult patients (18 - 59 years of age) referred to the Trakya University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery between September 2018 and December 2020 were examined clinically and radiographically.
Inclusion criteria:
- Patients who fit the requirements of the study such as attending follow up sessions and signing the informed consent.
- Patients who had bilateral asymptomatic vertical third molar teeth with impaction of class I, level C (21).
- Patients who had no significant medical diseases or use of drugs, were not pregnant, had no allergy, and did not smoke.
A patient was excluded if any of the following conditions were observed:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- •Volunteers over the age of 18
- •Patients who had no significant medical diseases or use of drugs, were not pregnant, had no allergy, and did not smoke.
- •Patients who had bilateral asymptomatic vertical third molar teeth with impaction of class I, level C according to Pell and Gregory Classification, and no history of recent antibiotic or anti-inflammatory treatment.
排除标准
- •Patients who had symptomatic impacted third molars.
- •Patients who had a medical history described above.
- •Patients under the age of 18.
结局指标
主要结局
Change in Facial Swelling
时间窗: 7 days
three measurements between 5 reference points were performed with a flexible ruler: tragus to soft tissue pogonion, lateral corner of the eye to the angle of the mandible, and tragus to the outer corner of the mouth. The sum of the 3 measurements was calculated preoperatively and repeated.The difference between each postoperative measurement and the preoperative measurement was determined as the value for facial swelling.
Change in pain
时间窗: 7 days
Postoperative pain was evaluated by the Visual Analogue Scale (VAS) from "0" (as no pain) to "10" (as the most severe pain experienced).
Change in trismus
时间窗: 7 days
Trismus was assessed by measuring the distance between the mesial incisal corners of the right upper and lower central teeth when the patient had maximum mouth opening. The difference between each postoperative measurement and the preoperative measurement indicated the trismus for that day.
次要结局
- Change in the number of analgesic(7 days)
研究者
Fatma Gülfeşan Çanakçi
Assistant Professor
Trakya University