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临床试验/NCT07208799
NCT07208799招募中2 期

Comparison of Effectiveness of Submucosal Dexamethasone and Methylprednisolone in Management of Postoperative Sequelae in Mandibular Parasymphysis Fractures

Nishtar Medical University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2026年1月3日最近更新:
干预措施

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
72
试验地点
1
主要终点
facial Edema

研究概览

简要总结

The rationale of the current research is to address the limitation of existing knowledge as it is not clear which of the two drugs (Dexamethasone or Methylprednisolone) is more effective in reduction of postoperative sequelae in patient with mandibular parasymphysis fracture. This study fills the gap by providing sound evidence on the preferred steroid option to help clinicians have more data to make decisions and improve patients' health. The result of this research will then be added to the evidence-based protocols for the treatment of parasymphysis fractures.

详细描述

Corticosteroids such as dexamethasone and methylprednisolone have been widely investigated in oral and maxillofacial surgery for their ability to reduce postoperative pain, edema, and trismus. Several randomized controlled trials have demonstrated significant benefit compared to placebo. For example, Hashim in 2020 reported mean VAS pain scores of 2.08 ± 0.92 with dexamethasone versus 3.43 ± 1.42 with placebo at 24 hours, and 0.50 ± 0.68 versus 2.23 ± 0.80 at 72 hours; edema scores were also lower (4.1 ± 1.43 vs. 6.0 ± 1.22 at 24 hours). Similarly, Mubeen in 2023 found that dexamethasone significantly reduced pain (2.16 ± 0.89 vs. 3.51 ± 1.23 at 24 hours) and edema (4.26 ± 1.42 vs. 5.38 ± 1.01 at 24 hours) compared to placebo in mandibular fracture patients. In contrast, Kandamani in 2022 showed that patients receiving submucosal methylprednisolone (40 mg Depomedrol) had significantly less pain, swelling, and trismus than controls at 48 and 72 hours (p < 0.05).In third molar surgery, Lim and Ngeow in 2017 observed that methylprednisolone produced significantly lower pain scores than placebo on POD 1 and 2, while dexamethasone also reduced pain but without statistical significance; both steroids, however, were equally effective in reducing swelling and trismus. Ayub and Fazal in 2022 further demonstrated that dexamethasone was superior to methylprednisolone in controlling trismus at 72 hours and swelling on postoperative days 1 and 2 (p < 0.005).

While these studies confirm the benefits of corticosteroids, none have directly compared dexamethasone and methylprednisolone in mandibular fractures, and most rely only on subjective outcomes such as VAS and facial measurements. To strengthen outcome assessment, Salgia in 2015 demonstrated that serum C-reactive protein (CRP) correlates directly with postoperative pain and inflammation, validating CRP as a reliable biomarker for quantifying the surgical inflammatory response.

To address these gaps, this double-blind randomized clinical trial will compare the effectiveness of submucosal dexamethasone (8 mg) and methylprednisolone (40 mg) in patients undergoing open reduction and internal fixation of isolated mandibular parasymphysis fractures. Pain and edema will be measured clinically at baseline, 24, and 72 hours, while serum CRP will be assessed as an objective biomarker of systemic inflammation. Analgesic consumption and adverse events will also be recorded. By combining subjective and objective outcomes, this study will provide robust evidence to guide the optimal corticosteroid choice in mandibular fracture management and contribute to evidence-based postoperative protocols.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 to
  • Both Gender.
  • Fracture less than a week old.
  • Isolated mandibular parasymphysis fractures.

排除标准

  • 1. Immunocompromised patients (due to increased risk of infection and complications).
  • 2. Patients experiencing acute pain from conditions such as pulpitis, abscesses, or other acute infections (to ensure that acute pain does not confound the study results).
  • 3. Patients reporting hypersensitivity to steroids (to avoid adverse reactions).
  • 4. Patients taking or requiring prophylactic antibiotics or anti-inflammatory drugs before surgery (to prevent confounding effects on study outcomes).
  • 5. Patients with a history of systemic steroid administration for 15 days (as this could affect the study's outcomes).
  • 6. Patients with chronic pain problems or mental disorders (to maintain consistency in response to treatment).
  • 7. Patients with comminuted fractures (to maintain consistency in fracture type).
  • 8. Pregnant or lactating women (to avoid potential risks to the fetus and nursing infant).
  • 9. Smokers who smoke at least 10 cigarettes per day for 2 years (to minimize the impact of smoking on healing and recovery).

研究组 & 干预措施

Dexamethasone group

Active Comparator

In this study dexamethasone sodium phosphate 8 mg (2 mL) will be administered submucosally at the surgical site 30 minutes before incision.

干预措施: Dexamethasone (Drug)

Methylprednisolone group

Active Comparator

In this study methylprednisolone sodium succinate 40 mg (2 mL) will be administered submucosally at the surgical site 30 minutes before incision.

干预措施: Methylprednisolone (Corticosteroid) (Drug)

结局指标

主要结局

facial Edema

时间窗: at baseline, 24 hours and 72 hours after surgery

Edema will be assessed in millimeters via measuring tape and assessed via the 9-line method at baseline, 24 hours and 72 hours after surgery. It measures edema at 9 standardized facial landmarks bilaterally (gonion to lateral canthus, tragus to ala of the nose, tragus to commissure of the lip, tragus to midline of the chin and gonion to gonion)

pain intensity

时间窗: at baseline, 24 hour and 72 hour postoperatively

: Visual Analog Scale (VAS) will be used to evaluate the pain at the baseline, 24 hours and 72 hours after the surgery. The axis is a 10-centimeter line with the endpoints showing 0 which is no pain, and 10 which is the most severe pain. Patients will put a line where they think their pain level is, and this will be recorded

次要结局

  • serum C-reactive protein (inflammation)(baseline, 24- and 72-hours post-op)
  • rescue analgesia(24 hour to 72 hour after surgery)

研究者

发起方
Nishtar Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ammar Ali Khalid

Resident, Department of Oral and Maxillofacial Surgery / Principal Investigator

University of Health Sciences Lahore

研究点 (1)

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