Compare submucosal dexamethasone versus methylprednisolone after parasymphysis mandible repair
Comparison of Effectiveness of Submucosal Dexamethasone and Methylprednisolone in Management of Postoperative Sequelae in Mandibular Parasymphysis Fractures
This research will try to see whether a single submucosal dose of dexamethasone or methylprednisolone better reduces pain, swelling, and jaw stiffness after surgical repair of parasymphysis mandibular fractures in adults aged 18–40.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Nishtar Medical University Academic / other |
| Locations | 1 site (Multan, Punjab Province) |
| Trial ID | NCT07208799 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial enrolls adults with isolated parasymphysis mandibular fractures less than one week old who undergo standard surgical repair. Participants receive a single submucosal injection of either dexamethasone or methylprednisolone at the surgical site, and postoperative outcomes such as pain (VAS), facial edema, and trismus are recorded over the early recovery period. The protocol excludes patients with immunocompromise, recent systemic steroid use, comminuted fractures, active odontogenic infection, or steroid hypersensitivity to reduce confounding. Results will be used to guide selection of perioperative corticosteroid therapy for this specific fracture type.
Who should consider this trial
Good fit: Adults aged 18–40 with an isolated mandibular parasymphysis fracture diagnosed within the past week who are fit for standard surgical repair and have no contra-indications to local steroid use.
Not a fit: Patients who are immunocompromised, have comminuted fractures, active dental infections, recent systemic steroid use, require preoperative antibiotics or anti-inflammatories, have chronic pain or mental disorders, or are steroid-sensitive are unlikely to be eligible or benefit from this protocol.
Why it matters
Potential benefit: If successful, the trial could identify the steroid that gives faster relief from pain, swelling, and limited mouth opening after parasymphysis fracture repair, supporting clearer evidence-based postoperative care.
How similar studies have performed: Placebo-controlled trials in oral and maxillofacial surgery have repeatedly shown that submucosal corticosteroids reduce pain, swelling, and trismus, while direct head-to-head comparisons between dexamethasone and methylprednisolone have shown mixed but promising results depending on the outcome and timing.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged 18 to 40. 2. Both Gender. 3. Fracture less than a week old. 4. Isolated mandibular parasymphysis fractures. Exclusion Criteria: * 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:
Where this trial is running
Multan, Punjab Province
- Nishtar Institute of Dentistry Multan — Multan, Punjab Province, Pakistan (Recruiting)
Study contacts
- Study coordinator: Ammar ali khalid, Bachelor of dental surgery
- Email: ammaraligoraya@gmail.com
- Phone: 923129216146
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.