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

NCT ID: NCT07208799

Last Updated: 2026-02-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-03
• Study Completion Date: 2026-12-01

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 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.

Conditions

Mandible Fracture; Edema Face; Pain Management; Corticosteroid Injection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Dexamethasone group

In this study dexamethasone sodium phosphate 8 mg (2 mL) will be administered submucosally at the surgical site 30 minutes before incision.

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

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

Methylprednisolone group

In this study methylprednisolone sodium succinate 40 mg (2 mL) will be administered submucosally at the surgical site 30 minutes before incision.

Group Type: ACTIVE_COMPARATOR

Methylprednisolone (Corticosteroid)

Intervention Type: DRUG

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

Interventions

Dexamethasone

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

Intervention Type: DRUG

Methylprednisolone (Corticosteroid)

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

Intervention Type: DRUG

Eligibility 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:

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nishtar Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ammar Ali Khalid

Resident, Department of Oral and Maxillofacial Surgery / Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: STUDY_DIRECTOR

NISHTAR INSITUTE OF DENTISTRY, MULTAN

Locations

Nishtar Institute of Dentistry Multan

Multan, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Ammar ali khalid, Bachelor of dental surgery

Role: CONTACT

ammaraligoraya@gmail.com

923129216146

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

Role: CONTACT

dramjad.omfs@gmail.com

+92 300 9630196

Facility Contacts

Ammar Ali Dr Ammar Ali, Bachelor in Dental surgery

Role: primary

ammaraligoraya@gmail.com

+923129216146

Amjad Bari Dr Amjad Bari, Master in Dental Surgery

Role: backup

dramjad.omfs@gmail.com

+923009630196

References

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.

Reference Type: BACKGROUND

PMID: 25961614 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33753671 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33745861 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37886924 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31909011 (View on PubMed)

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 35911819 (View on PubMed)

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 28144599 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25843816 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 28811076 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33195806 (View on PubMed)

Other Identifiers

U1111-1329-2007

Identifier Type: -

Identifier Source: org_study_id