A Phase 2 interventional study of Dexamethasone and Methylprednisolone (Corticosteroid) in Mandible Fracture, Edema Face and Pain Management, sponsored by Nishtar Medical University. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Nishtar Medical University · Phase 2, Interventional, and Prevention
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.
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.
91 studies on the registry are indexed under Mandibular Fractures; 24 are open to participants now.
This study's planned enrollment of 72 is above the median of 21 across 72 interventional studies indexed under Mandibular Fractures.
Browse Mandibular Fractures studies →Nishtar Medical University is the lead sponsor of 29 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
1. 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 to (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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this study dexamethasone sodium phosphate 8 mg (2 mL) will be administered submucosally at the surgical site 30 minutes before incision.
Drug: Dexamethasone
In this study methylprednisolone sodium succinate 40 mg (2 mL) will be administered submucosally at the surgical site 30 minutes before incision.
Drug: Methylprednisolone (Corticosteroid)
single dose of dexamethasone 8 mg (2 mL) administered submucosally at the surgical site 30 minutes before incision.
a single dose of methylprednisolone 40 mg (2 mL) will be administered submucosally at the surgical site 30 minutes before incision.
facial Edema
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)
Time frame: at baseline, 24 hours and 72 hours after surgery
pain intensity
: 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
Time frame: at baseline, 24 hour and 72 hour postoperatively
serum C-reactive protein (inflammation)
It will be measured in mg/dL at baseline, 24- and 72-hours post-op using the hospital laboratory's standard immunoassay method.
Time frame: baseline, 24- and 72-hours post-op
rescue analgesia
. 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.
Time frame: 24 hour to 72 hour after surgery
Plan to share: Undecided
Started Jan 2026 (actual). Primary completion is estimated for Nov 2026, 10 months after the start.
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Studies of the drugs tested here: Dexamethasone · Methylprednisolone
Nishtar Medical University