Effect of Submucosal Dexamethasone on Postoperative Pain, Swelling and Trismus After Periodontal Surgery: Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- VAS
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of submucosal 8 mg (2 mL) dexamethasone on postoperative pain, swelling, chewing efficiency, trismus, healing, and discomfort after periodontal flap surgery
详细描述
Periodontitis is an oral inflamatuar disease caused by specific microorganisms, is characterized by attachment loss, alveolar bone resorption, pathological pocket formation. This disease causes deep periodontal pockets associated with deep intrabony defects as well as various clinical problems. For management overcome these problems, various approaches have been proposed in the treatment of periodontitis, including initial periodontal treatment such as scaling and root planing, followed by flap surgery, resective bone surgery and periodontal regeneration when applicable. However, periodontal flap surgery applied in these approaches causes undesirable side effects such as pain and swelling. To overcome these disorders, studies continue to investigate by using various medication regimens include pre, intra or post operative drugs.
Dexamethasone is a synthetic steroidal anti-inflammatory drug used to control pain, swelling, and inflammation occurring in third molar surgeries, periodontal therapy and periodontal surgeries, implant surgery, and endodontic treatment. In the literature, dexamethasone application is frequently used in oral surgery before or after third molar tooth extraction. There is limited research on dexamethasone applications in periodontal flap surgery. lt has been evaluated the effectiveness of oral use of etoricoxib and dexamethasone in preventing pain after open flap debridement surgery. Some authors used 4 mg dexamethasone tablets before mucoperiosteal flap surgery and reported that the pain level in the dexamethasone group was lower than placebo at the 3rd hour. It has been reported positive results where preferred its use intravenously in the postoperative management of periodontal surgery. However, to the investigators knowledge, there is no study in the literature in which dexamethasone is applied submucosally after periodontal flap surgery. Accordingly, the hypothesis of this study was that submucosal application of dexamethasone in periodontal flap surgery would have a positive effect on pain and patient comfort. In light of all these scientific data, this study aimed to evaluate the effect of submucosal dexamethasone application periodontal flap surgery on postoperative pain, swelling, chewing efficiency, trismus, healing and discomfort.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •pocket depth ≥5mm;
- •systemically healthy;
- •without drug allergy;
- •without any blood disease;
- •not using medication (anti-platelet, anticoagulant, immunosuppressant medication);
- •received no any periodontal surgery in the last 6 months;
排除标准
- •poor oral hygiene;
- •any systemic disease that would affect the surgical operation;
- •problem with the kidneys or adrenal glands;
- •connective tissue disease or immunodeficiency;
- •breastfeeding period or pregnancy.
- •high dental anxiety
研究组 & 干预措施
Control Group
Patient received an indication periodontal flap surgery. In this randomized controlled split mouth study, the patient underwents periodontal flap surgery in their mandibular. Following local anesthesia (2% lidocaine and 1:100,000 epinephrine), sulcular incisions were made. Vertical incision was not used in any operation. The mucoperiosteal flap was elevated until the buccal and lingual bone defects were adequately exposed. Defects were thoroughly debrided firstly by using periodontal curettes, and then cleaned by piezoelectric ultrasonic scaler to ensure all granulation tissues were thoroughly removed. Buccal and lingual flaps were closed primarily. In the control group, 2 mL 0.9% isotonic sodium chloride (saline) with 27-gauge single-type disposable syringes was applied to the buccal surface of flap after the operation
干预措施: submucosal 2 mL 0.9% isotonic sodium chloride application (Drug)
Test Group
Patient received an indication periodontal flap surgery. In this randomized controlled split mouth study, the patient underwents periodontal flap surgery in their mandibular. Following local anesthesia (2% lidocaine and 1:100,000 epinephrine), sulcular incisions were made. Vertical incision was not used in any operation. The mucoperiosteal flap was elevated until the buccal and lingual bone defects were adequately exposed. Defects were thoroughly debrided firstly by using periodontal curettes, and then cleaned by piezoelectric ultrasonic scaler to ensure all granulation tissues were thoroughly removed. Buccal and lingual flaps were closed primarily. In the test group, 8 mg (2 mL) submucosal dexamethasone with 27-gauge single-type disposable syringes was applied to the buccal surface of flap after the operation
干预措施: submucosal 8 mg (2 mL) dexamethasone application (Drug)
结局指标
主要结局
VAS
时间窗: Every hour for the first 8 hours on the first day of the operation, and three times a day on the 2nd, 3rd, 4th and 7th days
Visual analogue scale (VAS) was assessed to monitor the degree of pain.VAS is a scale that rates pain severity from 0 to 10. (0 = no pain to 10 = severe pain),
Swelling
时间窗: Patients were evaluated for swelling on the preoperative, the1st, 2nd, and 7th days after the operation
Linear measurements were taken for swelling with a millimeter tape measure. Measurements were made between the angle of the mandible and the mentus, labial commissure, nasal ala, outer corner of the eye and tragus. The average of these five measurements was noted.
NRS-101
时间窗: Every hour for the first 8 hours on the first day of the operation, and three times a day on the 2nd, 3rd, 4th and 7th days
101-point numeric rate scale (NRS-101) was assessed to monitor the degree of pain. NRS-101 is a 101-point numerical ratio scale that rates pain severity from 0 to 100. (0 = no pain to 100 = severe pain),
次要结局
- Discomfort(It was evaluated for discomfort on the 1st, 2nd, and 7th days after the operation)
- Trismus(It was evaluated for trismus on the preoperative, the 1st, 2nd, and 7th days after the operation)
- Analgesics consumed(The number of analgesics used each day during the first 7 days was noted by the patient in the pain diary)
- Chewing efficiency(It was evaluated for chewing efficiency on the 1st, 2nd, and 7th days after the operation)
- Healing of operation area(It was evaluated for healing of operation area on the 1st, 2nd, and 7th days after the operation)
- General satisfaction(14th day after operation)
研究者
Dicle Altındal
DDS, Assistant Professor
Yuzuncu Yıl University