drugset / Trial / NCT07208799
Comparison of Submucosal Dexamethasone and Methylprednisolone in Postoperative Sequelae of Parasymphsis Fractures
RandomizedParallel-groupTriple-blindPrevention
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.
Timeline
- Start
- 2026-01-03
- Primary completion
- 2026-11-30
- Completion
- 2026-12-01
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dexamethasone | Small molecule | 8 mg | Other |
| Comparator | Methylprednisolone | Other / unclassified | 40 mg | Other |