Effect of Preoperative 4 mg Submucosal Dexamethasone on Postoperative Discomfort After Impacted Mandibular Third Molar Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 268
- 主要终点
- Postoperative Pain Assessed by Visual Analogue Scale (VAS)
研究概览
简要总结
This study aims to determine whether giving a single dose of dexamethasone before surgery can reduce pain and difficulty in opening the mouth after removal of an impacted lower wisdom tooth. Pain and limited mouth opening are common problems after this procedure and can affect eating, speaking, and daily activities.
A total of 268 patients aged 18 to 55 years who require surgical removal of an impacted mandibular third molar will be included. Participants will be randomly assigned to one of two groups. One group will receive a 4 mg dexamethasone injection under the gum before surgery, while the other group will not receive this medication. All patients will undergo the same surgical procedure and receive standard postoperative care.
Pain will be measured using a visual analogue scale, and mouth opening will be assessed using a standard measuring method. These outcomes will be recorded on the second and seventh days after surgery.
The results of this study will help determine whether preoperative dexamethasone is an effective and simple method to reduce postoperative discomfort and improve recovery after third molar surgery.
详细描述
This randomized controlled trial is designed to evaluate the efficacy of a single preoperative 4 mg submucosal dexamethasone injection in reducing postoperative discomfort following surgical removal of impacted mandibular third molars. Postoperative discomfort is defined by two primary components: pain intensity and degree of trismus.
The study will be conducted at the Department of Oral and Maxillofacial Surgery, MTI-Hayatabad Medical Complex, Peshawar, Pakistan. A total of 268 participants aged 18-55 years requiring surgical extraction of impacted mandibular third molars will be enrolled using non-probability consecutive sampling. Participants with systemic disease, pregnancy, lactation, recent use of antibiotics or anti-inflammatory drugs, or periodontal disease will be excluded.
Eligible participants will be randomly allocated into two equal groups (n=134 each) using a computer-generated randomization method. The intervention group will receive a single 4 mg submucosal injection of dexamethasone at the surgical site following administration of local anesthesia. The control group will undergo the same surgical procedure without administration of dexamethasone.
All procedures will be standardized, including surgical technique (Ward's incision, bone removal, and suturing) and postoperative analgesia (diclofenac 50 mg). No blinding will be performed due to the nature of the intervention.
Pain intensity will be assessed using a 10-cm visual analogue scale (VAS), while trismus will be evaluated by measuring maximum inter-incisal distance (in millimeters) using a vernier caliper. Measurements will be recorded preoperatively and on postoperative days 2 and 7.
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
- None
盲法说明
This study is conducted as an open-label trial. No blinding is applied to participants, care providers, investigators, or outcome assessors due to the nature of the intervention (submucosal injection versus no intervention).
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 55 years
- •Patients requiring surgical extraction of impacted mandibular third molars
- •Patients willing to provide informed consent
排除标准
- •Patients with systemic diseases
- •Patients with periodontal disease
- •Pregnant or lactating women
- •Patients who have used antibiotics or anti-inflammatory drugs within the past 7 days
- •Patients with known hypersensitivity to dexamethasone
研究组 & 干预措施
Dexamethasone Group
Participants receive a single preoperative 4 mg submucosal injection of dexamethasone at the surgical site following administration of local anesthesia. All patients undergo standardized surgical extraction of impacted mandibular third molars and receive identical postoperative care.
干预措施: No intervention (Other)
No Drug Control Group
Participants undergo standardized surgical extraction of impacted mandibular third molars without receiving dexamethasone or any study drug. All patients receive identical postoperative care, including analgesia, as per institutional protocol.
Dexamethasone Group
Participants receive a single preoperative 4 mg submucosal injection of dexamethasone at the surgical site following administration of local anesthesia. All patients undergo standardized surgical extraction of impacted mandibular third molars and receive identical postoperative care.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Postoperative Pain Assessed by Visual Analogue Scale (VAS)
时间窗: Postoperative Days 2 and 7
Pain intensity will be measured using a 10-cm visual analogue scale (VAS), where 0 indicates no pain and 10 indicates worst possible pain. Scores will be recorded on postoperative day 2 and day 7.
次要结局
未报告次要终点
研究者
Abdul Basit Khan
Postgraduate Resident
Hayat Abad Medical Complex, Peshawar