Comparative Efficacy of 4 mg vs. 8 mg Submucosal Dexamethasone in Postoperative Pain Management After Dental Implant Surgery: A Randomized Double-Blind Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Postoperative pain assessed using Visual Analog Scale (VAS)
研究概览
简要总结
This study aims to compare the effectiveness of 4mg and 8mg dexamethasone administered submucosally in reducing postoperative pain after dental implant surgery. Participants will be randomly assigned to receive either 4mg dexamethasone, 8mg dexamethasone, or a placebo (normal saline) at the surgical site.
Later, postoperative pain will be assessed using a Visual Analog Scale at 6 hours after the surgery and daily for the next 6 days. Also the number of pain-relief tablets consumed after the surgery will be recorded.
Preoperative anxiety will be assessed using Generalized Anxiety Disorder-7 (GAD-7) questionnaire to assess its association with postoperative pain scores.
The results of this study will help determine the optimal dose of dexamethasone that is effective for postoperative pain control following dental implant surgery.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males & females
- •Age range (21-80)
- •ASA I & II according to (American Society of Anesthesiologists) classification
- •Single tooth implant
- •Type 3 & type 4 implant placement timing (Chen and Buser, 2009)
排除标准
- •Any known allergy to any medications which will be used in the study
- •Smokers/ Alcoholics
- •Pregnant and lactating women
- •Bone augmentation/ sinus lifting required during the surgery
- •The need of antibiotic prophylaxis
研究组 & 干预措施
8mg Dexamethasone
8mg/2ml dexamethasone injection.
干预措施: Dexamethasone 8Mg Solution for Injection (Drug)
4mg Dexamethasone
4mg/1ml Dexamethasone ampoule + 1ml of sterile normal saline for injection. Mixing dexamethasone with sterile normal saline for injection is considered safe and has no effect on drug potency and efficacy based on current evidence.
干预措施: Dexamethasone 4 Mg/mL Injectable Solution (Drug)
Placebo
2 ml of sterile normal saline for injection.
干预措施: Saline (NaCl 0,9 %) (placebo) (Drug)
结局指标
主要结局
Postoperative pain assessed using Visual Analog Scale (VAS)
时间窗: at 6 hours postoperatively and then once daily for the following 6 days
Postoperative pain will be assessed using a 10-cm visual analog scale in patients following single dental implant surgery after submucosal administration of dexamethasone or placebo
次要结局
- Number of postoperative analgesic tablets consumed(Postoperatively for 7 days)
- Correlation between preoperative anxiety (GAD-7) and postoperative pain score(Anxiety will be assessed preoperatively on the day of the surgery before implant placement)
研究者
Shurooq Al-Hinai
Principal Investigator
Oman Ministry of Health