COMPARISON OF EFFECTIVENESS OF SUBMUCOSAL DEXAMETHASONE AND METHYLPREDNISOLONE IN MANAGEMENT OF POST OPERATIVE SEQUELAE IN MANDIBULAR PARASYMPHYSIS FRACTURES
- Conditions
- Mandible FractureEdema FacePain ManagementCorticosteroid Injection
- Interventions
- Registration Number
- NCT07208799
- Lead Sponsor
- Nishtar Medical University
- Brief Summary
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.
- Detailed Description
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 et al. (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 et al. (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 et al. (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 (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 (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 et al. (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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 72
- Patients aged 18 to 40.
- Both Gender.
- Fracture less than a week old.
- Isolated mandibular parasymphysis fractures.
-
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).
ria:
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dexamethasone group Dexamethasone In this study dexamethasone sodium phosphate 8 mg (2 mL) will be administered submucosally at the surgical site 30 minutes before incision. Methylprednisolone group Methylprednisolone (Corticosteroid) In this study methylprednisolone sodium succinate 40 mg (2 mL) will be administered submucosally at the surgical site 30 minutes before incision.
- Primary Outcome Measures
Name Time Method facial Edema 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 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
- Secondary Outcome Measures
Name Time Method serum C-reactive protein (inflammation) baseline, 24- and 72-hours post-op It will be measured in mg/dL at baseline, 24- and 72-hours post-op using the hospital laboratory's standard immunoassay method.
rescue analgesia 24 hour to 72 hour after surgery . Rescue analgesia will be given if VAS ≥ 4, using a fixed dose of tramadol 50 mg IV/IM (single dose). If pain persists after 6-8 hours, the same 50 mg dose may be repeated, not exceeding 400 mg in 24 hours. Total rescue analgesic consumption within 72 hours will be recorded as a secondary outcome.