Comparison of Submucosal Dexamethasone and Methylprednisolone in Postoperative Sequelae of Parasymphsis Fractures

NCT07208799 | Recruiting Phase 2

• 1 other identifier: U1111-1329-2007
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Mandible Fracture; Edema Face; Pain Management; Corticosteroid Injection

Keywords

mandible fracture; edema; pain; submucosal; dexamethasone; methylprednisolone

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  at baseline, 24 hour and 72 hour postoperatively

Secondary Outcomes (2)

• serum C-reactive protein (inflammation)

  baseline, 24- and 72-hours post-op

• rescue analgesia

  24 hour to 72 hour after surgery

Study Arms (2)

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.

Drug: Dexamethasone

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.

Drug: Methylprednisolone (Corticosteroid)

Interventions

Dexamethasone DRUG

single dose of dexamethasone 8 mg (2 mL) administered submucosally at the surgical site 30 minutes before incision.

Dexamethasone group

Methylprednisolone (Corticosteroid) DRUG

a single dose of methylprednisolone 40 mg (2 mL) will be administered submucosally at the surgical site 30 minutes before incision.

Methylprednisolone group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 18 to 40.
• Both Gender.
• Fracture less than a week old.
• Isolated mandibular parasymphysis fractures.

You may not qualify if:

• \. Immunocompromised patients (due to increased risk of infection and complications).
• \. 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).
• \. Patients reporting hypersensitivity to steroids (to avoid adverse reactions).
• \. Patients taking or requiring prophylactic antibiotics or anti-inflammatory drugs before surgery (to prevent confounding effects on study outcomes).
• \. Patients with a history of systemic steroid administration for 15 days (as this could affect the study's outcomes).
• \. Patients with chronic pain problems or mental disorders (to maintain consistency in response to treatment).
• \. Patients with comminuted fractures (to maintain consistency in fracture type).
• \. Pregnant or lactating women (to avoid potential risks to the fetus and nursing infant).
• \. Smokers who smoke at least 10 cigarettes per day for 2 years (to minimize the impact of smoking on healing and recovery).
• ria:

Sponsors & Collaborators

• Nishtar Medical University: lead

Study Sites (1)

Nishtar Institute of Dentistry Multan

Multan, Punjab Province, 60000, Pakistan

RECRUITING

Related Publications (13)

• Salgia G, Kulkarni DG, Shetty L. C-reactive protein estimation: a quantitative analysis for three nonsteroidal anti-inflammatory drugs: a randomized control trial. Indian J Dent Res. 2015 Jan-Feb;26(1):43-7. doi: 10.4103/0970-9290.156797.

  PMID: 25961614 BACKGROUND

• Saravanan T, Balaguhan B, Venkatesh A, Geethapriya N, Goldpearlinmary, Karthick A. Prevalence of mandibular fractures. Indian J Dent Res. 2020 Nov-Dec;31(6):971-974. doi: 10.4103/ijdr.IJDR_286_18.

  PMID: 33753671 BACKGROUND

• Singh AK, Dhungel S, Bhattarai K, Roychoudhury A. Do the Benefits of Systemic Corticosteroids Outweigh Adverse Effects During Maxillofacial Trauma Surgery? A Systematic Review and Meta-Analysis. J Oral Maxillofac Surg. 2021 Jul;79(7):1530.e1-1530.e21. doi: 10.1016/j.joms.2021.02.003. Epub 2021 Feb 9.

  PMID: 33745861 BACKGROUND

• Nils HJ, Arce Recatala C, Castano A, Ribas D, Flores-Fraile J. Efficacy/Safety of the Use of Glucocorticoids in Oral and Maxillofacial Surgery. Dent J (Basel). 2023 Oct 17;11(10):239. doi: 10.3390/dj11100239.

  PMID: 37886924 BACKGROUND

• Mohd YQ, Reddy S, Sinha R, Agarwal A, Fatima U, Abidullah M. Three-Dimensional Miniplate: For the Management of Mandibular Parasymphysis Fractures. Ann Maxillofac Surg. 2019 Jul-Dec;9(2):333-339. doi: 10.4103/ams.ams_172_17.

  PMID: 31909011 BACKGROUND

• Mohamed, N.A., Hassan, R.S. & El Halawani, G. 2024. Comparison between perpendicular and conventional fixation in symphyseal and para symphyseal mandibular fractures (Randomized controlled trial). Alexandria Dental Journal.

  BACKGROUND

• Kandamani J, Gouthaman SS, Ramakrishnan DS, Kumar MPS, Muthusekar MR. Evaluation of effect of submucosal administration of depomedrol in management of postoperative sequelae in mandibular fractures: A randomized clinical trial study. Natl J Maxillofac Surg. 2022 Jan-Apr;13(1):84-89. doi: 10.4103/njms.NJMS_118_20. Epub 2022 Apr 20.

  PMID: 35911819 BACKGROUND

• Hashim, M.H., Shadab, R., Kali, B., Khan, N., Tariq, Z.R., Ali, S. and Zahid, S., 2020. Role of dexamethasone at surgical site in the control of pain and edema in the management of mandibular fracture osteosynthesis. Pakistan Oral & Dental Journal, 40(2), pp.72-75. Hunter, T.B. 2017. Fracture fixation. Radiologic Guide to Orthopedic Devices:19.

  BACKGROUND

• Gadicherla S, Sasikumar P, Gill SS, Bhagania M, Kamath AT, Pentapati KC. Mandibular Fractures and Associated Factors at a Tertiary Care Hospital. Arch Trauma Res. 2016 Sep 19;5(4):e30574. doi: 10.5812/atr.30574. eCollection 2016 Dec.

  PMID: 28144599 BACKGROUND

• Dongol A, Jaisani MR, Pradhan L, Dulal S, Sagtani A. A randomized clinical trial of the effects of submucosal dexamethasone after surgery for mandibular fractures. J Oral Maxillofac Surg. 2015 Jun;73(6):1124-32. doi: 10.1016/j.joms.2014.12.042. Epub 2015 Jan 13.

  PMID: 25843816 BACKGROUND

• Dergin, G., Emes, Y. & Aybar, B. 2019. Evaluation and management of mandibular fracture. Trauma in dentistry. https://www.intechopen.com/chapters/65088.

  BACKGROUND

• Chugh A, Singh S, Mittal Y, Chugh V. Submucosal injection of dexamethasone and methylprednisolone for the control of postoperative sequelae after third molar surgery: randomized controlled trial. Int J Oral Maxillofac Surg. 2018 Feb;47(2):228-233. doi: 10.1016/j.ijom.2017.07.009. Epub 2017 Aug 12.

  PMID: 28811076 BACKGROUND

• Sugragan C, Sirintawat N, Kiattavornchareon S, Khoo LK, Kc K, Wongsirichat N. Do corticosteroids reduce postoperative pain following third molar intervention? J Dent Anesth Pain Med. 2020 Oct;20(5):281-291. doi: 10.17245/jdapm.2020.20.5.281. Epub 2020 Oct 30.

  PMID: 33195806 BACKGROUND

MeSH Terms

Conditions

Mandibular Fractures; Agnosia; Edema; Pain

Interventions

Dexamethasone; Methylprednisolone; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Prednisolone; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Dr amjad ali Bari, M.D.S (OMFS)

  NISHTAR INSITUTE OF DENTISTRY, MULTAN

  STUDY DIRECTOR

Central Study Contacts

Ammar ali khalid, Bachelor of dental surgery

CONTACT

923129216146; ammaraligoraya@gmail.com

Dr amjad Bari, M.D.S (OMFS)

CONTACT

+92 300 9630196; dramjad.omfs@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, Department of Oral and Maxillofacial Surgery / Principal Investigator

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: October 6, 2025
• Study Start: January 3, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

PA (1)