Comparison Of The Effectiveness Of Submucosal Corticosteroid Injection And Elastic Therapeutic Bandage Applications On Pain, Swelling And Trismus After Surgical Removal Of Mandibular Third Molar Teeth
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity-2
研究概览
简要总结
In this study; Among the patients randomized because of severe postoperative sequelae expected as a result of radiological and clinical examinations; nonsteroid antiinflammatory drug prescribed group compared with preoperative single dose intraoral submucosal corticosteroid administration and therapeutic elastic bandage application considering inflammatory symptoms' severity and health related quality of life following surgical removal of impacted third molars. The study hypothesis was formed stating that corticosteroid injection and elastic bandage application would reduce the inflammatory symptoms more than NSAID.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18-65 years
- •American Society of Anesthesiologists (ASA) Class 1 physiological status
- •Consistent radiological and clinical data
- •Volunteered to participate in the study
- •Surgical difficulty score above 5 which was determined according to Pederson scale.
排除标准
- •Being out of age range
- •Analgesic or antibiotic therapy history in last 30 days due to symptoms of related third molar
- •Smoking cigarette
- •Any pathology associated with impacted third molar
- •Active complaints on preoperative examination on the day of surgery
- •Immunosuppressed or diagnosed with malignancy
- •Diagnosed chronic diseases such as; Diabetes mellitus (DM), hypertension, cerebrovascular event, psychiatric diseases, coagulopathies
- •Autoimmune diseases
- •If total operation time exceeds 45 minutes
- •Patients who could not attend regular follow-up visits
- •Allergy to the medications prescribed or utilized in study protocol
- •Inconsistent clinical and radiological data
研究组 & 干预措施
Postoperative NSAID Prescription
Patients in this arm received common postoperative prescriptions following removal of their impacted third molars for seven days; twice a day 500 mg amoxicillin+125 mg clavulanic acid, twice a day 25 mg dexketoprofen trometamol and three times a day 1.5 mg/ml clorhexidine gluconate+1.2 mg/ml benzydamine hydrochloride containing 200 ml mouthwash.
干预措施: Dexketoprofen Trometamol (Drug)
Preoperative Submucosal Corticosteroid Injection
Patients in this arm were administered 8mg/2ml dexamethasone 21-phosphate preoperatively after local anesthesia were obtained. Injection site was the depth of buccal sulcus near operation site. For the patients in this arm 25 mg dexketoprofen trometamol was excluded from postoperative prescription in order not to affect the anti-inflammatory effects of corticosteroid. Instead of NSAID, three times a day 500 mg paracetamol was prescribed. The patients were advised not to exceed maximal dosage of 3000 mg (6 tablets) in a day.
干预措施: Dexamethasone 21-Phosphate (Drug)
Postoperative Therapeutic Elastic Bandage Application
In this arm the therapeutic elastic bandage applications were immediately performed after removal of mandibular third molars. The distance between tragus-lateral commissura line and supraclavicular lymph nodes was measured and the tapes were then cut into 5 tails. The base of the tape was placed on supraclavicular lymph nodes and tails were placed on the site to cover parotid, submandibular, submental and superficial cervical lymph nodes. The tapes were removed on postoperative second day.
干预措施: Therapeutic Elastic Bandage (Device)
结局指标
主要结局
Postoperative Pain Intensity-2
时间窗: Postoperative Seventh Day
The patients were asked to mark their pain intensities on a Numerical Rating Scale in which '0' means no pain, '5' means moderate pain and '10' means worst imaginable pain.
Change From Baseline Maximal Mouth Opening on Postoperative Follow Up Visits
时间窗: Preoperatively on the day of surgery, postoperative second and seventh days.
All patients' maximal mouth opening were measured and recorded as the distance between upper and lower right central incisors.
Change From Baseline Facial Measurements on Postoperative Follow Up Visits
时间窗: Preoperatively on the day of surgery, postoperative second and seventh days.
Measurements were performed on the ipsilateral site between tragus and lateral commissura, lateral canthus and angle of mandible with a flexible ruler. The obtained values' average amounts were calculated and recorded for each patient.
Oral Analgesic Consumption-1
时间窗: Postoperative Second Day
The patients were asked to record the amounts of consumed analgesic tablets (tablets per day) until first follow up visit.
Oral Analgesic Consumption-2
时间窗: Postoperative Seventh Day
The patients were asked to record the amounts of consumed analgesic tablets (tablets per day) between first and last follow up visits.
Postoperative Pain Intensity-1
时间窗: Postoperative Second Day
The patients were asked to mark their pain intensities on a Numerical Rating Scale in which '0' means no pain, '5' means moderate pain and '10' means worst imaginable pain.
Preoperative Pain Intensity
时间窗: On the day of surgery preoperatively
The patients were asked to mark their pain intensities on a Numerical Rating Scale in which '0' means no pain, '5' means moderate pain and '10' means worst imaginable pain on the day of surgery preoperatively.
次要结局
- Oral Health Impact Profile(Preoperatively on the day of surgery, postoperative second and seventh days.)
- Postoperative Symptom Severity Evaluation(Postoperative seventh day.)
- Wound Healing Scores(Postoperative second and seventh days.)
研究者
Aras Erdil
Research Assistant
Tokat Gaziosmanpasa University