Therapeutic Management of Dexamethasone in Patients Undergoing Endodontics: Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity (Visual Analog Scale Score)
研究概览
简要总结
This Phase IV randomized clinical trial (RCT) evaluated the efficacy of preoperative administration of a single 4 mg oral dose of dexamethasone in reducing postoperative pain and inflammation following endodontic treatment. Conducted at the Department of Endodontics, PhD Program, Faculty of Dentistry, University of Salamanca, the study included 82 participants who were randomly assigned to either the test group (preoperative dexamethasone) or the control group (postoperative ibuprofen 400 mg every 4 hours).
Pain intensity was measured using the Visual Analog Scale (VAS) at 4, 6, 8, 12, and 24 hours postoperatively. Results indicated significantly lower pain perception in the dexamethasone group compared to the ibuprofen group at all time points, with the majority of dexamethasone-treated patients reporting only mild pain. No adverse effects were observed in either group, and no patient required additional rescue analgesia.
The findings suggest that a single preoperative dose of dexamethasone is a safe and effective strategy for managing postoperative pain in endodontic procedures, providing superior analgesia compared to the standard postoperative ibuprofen regimen.
Keywords: Endodontic pain, dexamethasone, preoperative analgesia, randomized clinical trial, inflammation control, corticosteroids, endodontics.
详细描述
Background and Rationale:
Endodontic treatment is a standard dental procedure aimed at preserving teeth with irreversible pulp damage or infection. A common complication following such procedures is postoperative pain and inflammation, typically managed with nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen. However, corticosteroids like dexamethasone, known for their potent anti-inflammatory and analgesic properties, may offer an alternative approach.
Dexamethasone is a long-acting glucocorticoid that inhibits phospholipase A2, thereby reducing the production of prostaglandins and leukotrienes-key mediators in the inflammatory cascade. This mechanism potentially prevents peripheral sensitization and hyperalgesia, which are central to post-endodontic pain. While dexamethasone has shown efficacy in oral surgery, its use as a preoperative analgesic in endodontics remains under-investigated.
Study Objectives:
The primary objective is to evaluate whether a single 4 mg oral dose of dexamethasone administered preoperatively reduces postoperative pain following endodontic treatment. Secondary objectives include assessing the need for rescue analgesia and monitoring for adverse effects.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the following criteria to be eligible for the study:
- •Age Range: 20 to 50 years old.
- •Indication for Endodontic Treatment: Patients requiring root canal therapy due to irreversible pulpitis (with or without apical lesion), pulp necrosis, retreatment with periapical lesion, or endodontic surgery.
- •Eligible Teeth: Any dental group (anterior, premolar, molar, both maxillary and mandibular).
- •General Health Status: Classified as ASA I (healthy individuals without systemic conditions) according to the American Society of Anesthesiologists (ASA) Physical Status Classification.
- •Consent: Willingness to participate in the study and ability to provide signed informed consent.
排除标准
- •Participants will be excluded if any of the following conditions apply:
- •Age: Under 20 or over 50 years old.
- •Medical Conditions:
- •Immunocompromised individuals (e.g., HIV/AIDS, cancer patients undergoing chemotherapy).
- •Systemic diseases such as diabetes mellitus, osteoporosis, acute psychosis, glaucoma, cataracts.
- •Patients with tuberculosis or systemic fungal infections. Gastrointestinal conditions such as ulcerative colitis, peptic ulcers, or diverticulitis.
- •Medication Use: Use of NSAIDs or corticosteroids within 48 hours prior to the intervention. Regular use of barbiturates.
- •Dental Factors: Tooth fractures involving the roots. Severe dental hypersensitivity that may interfere with pain assessment.
- •Pregnancy and Lactation: Pregnant or breastfeeding women will be excluded due to potential effects of dexamethasone.
- •Non-Compliance: Patients who decline participation or are unwilling to follow study procedures, including pain assessment and follow-up.
研究组 & 干预措施
Dexamethasone Group
Participants in this group received a single 4 mg oral dose of dexamethasone 1 hour before undergoing endodontic treatment. No additional preoperative analgesics were administered. Standard endodontic procedures, including local anesthesia, were performed. Post-treatment, no routine analgesic medication was provided unless additional pain relief was required. Pain intensity was assessed at 4, 6, 8, 12, and 24 hours using the Visual Analog Scale (VAS) to evaluate the efficacy of preoperative dexamethasone in controlling postoperative pain and inflammation.
Arm 2
干预措施: Dexamethasone 4 mg (Drug)
Ibuprofen Group
Participants in this group received no preoperative medication but were prescribed 400 mg of ibuprofen every 4 hours postoperatively for pain management. The same standard endodontic procedures were performed. Pain levels were recorded at 4, 6, 8, 12, and 24 hours using the VAS scale to compare the effectiveness of postoperative ibuprofen with preoperative dexamethasone.
干预措施: Ibuprofen group (Drug)
结局指标
主要结局
Postoperative Pain Intensity (Visual Analog Scale Score)
时间窗: 4, 6, 8, 12, and 24 hours post-endodontic treatment
Description: Pain intensity will be measured using the Visual Analog Scale (VAS), a 10-centimeter horizontal line where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Participants will mark their perceived pain levels at each time point to assess postoperative discomfort following endodontic treatment. Scale Range: 0 (no pain) to 10 (worst pain) Interpretation: Higher scores indicate a worse outcome (greater pain intensity).
次要结局
- Need for Rescue Analgesia(24 hours post-endodontic treatment)
研究者
Heilyn Nils
Principal Investigator
University of Salamanca