the Effect of Ozone Oil on the Post Operative Sequelae After Surgical Removal of Impacted Mandibular Third Molar: Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- measuring pain severity after extraction using numerical rating scale
研究概览
简要总结
This study aimed to evaluate the effectiveness of intra socket application of Ozone oil on postoperative pain, trismus and facial swelling following the surgical extraction of impacted mandibular third molars.
详细描述
Background: Surgical removal of impacted teeth is frequently encountered in dental clinic. Pain, trismus, and swelling are common postoperative sequelae for third molar surgery. Different methods have been used to prevent or decrease these postoperative sequelae, one of them is the application of Ozone oil that shows many advantages in controlling the inflammation, thus reducing pain, trismus and swelling. There is an evidence to suggest that it may have significant effects in the synthesis, release, and metabolism of a series of biochemical substances.
Aim of the study: This study aimed to evaluate the effects of local application of Ozone oil on postoperative pain, trismus and facial swelling following the surgical removal of mandibular third molars.
Materials and Methods
This triple blind randomized prospective clinical trial was performed during period from January 2021 until the end of July 2021, on (40) patients, age range was between (18-35) years, with impacted mandibular third molar in similar positions (Class I-II and position B, Pell and Gregory's classification). They were randomly assigned into two groups, 20 patients for Ozone oil group treated with topical application of Ozone oil in their socket, and 20 patients into the control group in which the Ozone oil syringe was inserted inside the patient mouth without applying the treatment. Assessment of trismus was done by measuring the maximum mouth opening and the swelling was assessed by measuring distance between five predetermined points (tragus, angle of mouth, pogonion, lateral angle of eye and angle of mandible). These measurements were done before surgery as a baseline record as well as at the second and seventh postoperative days. Pain was evaluated using numeric rating scale from the day of surgery until the seventh day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with mandibular third molar (Class I-II and position B, Pell and Gregory's classification)
- •Patients who were willing to compliance with study
- •the Surgical site free of active infection.
- •patients without any systemic disease that might affect the healing process such as uncontrolled diabetes.
排除标准
- •Medical condition that prevent surgical intervention such as patient with bleeding disorders, recent myocardial infarction, psychiatric problem, uncontrolled systemic diseases, and patients with pacemaker, immunocompromised status and who were taking corticosteroidand anti-inflammatory drugs.
- •2.. Poor oral hygiene and/or active advanced periodontal disease and, or patients with active local infection in relation to the third molar such as Pericoronitis.
- •Any systemic condition that interfere with the use of ozone such as autoimmune disorders, myasthenia, hyperthyroidism, myocardial infarction, alcohol intoxication and ozone allergy
研究组 & 干预措施
drug arm
In the study group the (0.5 ml) of Ozone oil (perio3®, Hoffmann, German) was placed inside the socket of the extracted tooth filling it completely following suturing of the flap
干预措施: Ozone-Based Agent (Drug)
placebo arm
the ozone oil syringe was placed inside the patient mouth without applying the oil.
干预措施: Placebo (Drug)
结局指标
主要结局
measuring pain severity after extraction using numerical rating scale
时间窗: 7 days
severity measured using numerical rating scale from the first postoperative day to 7th day
assessing the change in mouth opening using vernier caliper
时间窗: baseline , the 2nd and 7th postoperative day
severity, baseline , the 2nd and 7th postoperative day
measuring the change in facial measurement to assess the swelling
时间窗: baseline , the 2nd and 7th postoperative day
severity, baseline , the 2nd and 7th postoperative day
次要结局
- surgical difficulty(through out the operation duration, an average of 1 hour)
- class(through out the operation duration, an average of 1 hour)
- angulation of impaction(through out the operation duration, an average of 1 hour)
研究者
Maiyada A. Talib
dentist
University of Baghdad