Mandible FracturePhase 2NCT07208799
Comparison of Submucosal Dexamethasone and Methylprednisolone in Postoperative Sequelae of Parasymphsis Fractures
A Phase 2 study testing Dexamethasone and Methylprednisolone (Corticosteroid) in people with Mandible Fracture and Edema Face, run by Nishtar Medical University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Mandible Fracture, Edema Face, Pain Management
- What is being tested?
- Dexamethasone and Methylprednisolone (Corticosteroid)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Jan 2026to 1 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18 to 40.
- Both Gender.
- Fracture less than a week old.
- Isolated mandibular parasymphysis fractures.
Who cannot join
- 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).
Show all 10Show fewer
- 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:
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Nishtar Institute of Dentistry Multan
Multan, Punjab Province, 60000
Ammar Ali Dr Ammar Ali, Bachelor in Dental surgery, +923129216146, ammaraligoraya@gmail.com
Amjad Bari Dr Amjad Bari, Master in Dental Surgery, +923009630196, dramjad.omfs@gmail.com
About this study
Official title: Comparison of Effectiveness of Submucosal Dexamethasone and Methylprednisolone in Management of Postoperative Sequelae in Mandibular Parasymphysis Fractures
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.
Read the 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.
- Being tested
- Dexamethasone, Methylprednisolone (Corticosteroid)
- Keywords
- mandible fracture, edema, pain, submucosal, dexamethasone, methylprednisolone
- Medical subject headings
- Mandibular Fractures, Agnosia, Edema, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
single dose of dexamethasone 8 mg (2 mL) administered submucosally at the surgical site 30 minutes before incision.
Methylprednisolone (Corticosteroid)Drug
a single dose of methylprednisolone 40 mg (2 mL) will be administered submucosally at the surgical site 30 minutes before incision.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Methylprednisolone (Corticosteroid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: at baseline, 24 hour and 72 hour postoperatively
Secondary outcomes (2)
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.
Measured: 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.
Measured: 24 hour to 72 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start3 Jan 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Mandible FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nishtar Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ammar Ali Khalid, University of Health Sciences Lahore
- Investigators
- Dr amjad ali Bari, M.D.S (OMFS), Study director, NISHTAR INSITUTE OF DENTISTRY, MULTAN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208799
- Sponsor's protocol ID
- U1111-1329-2007
- Status last verified
- Apr 2026
- First submitted
- 28 Sep 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25961614Saravanan 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.
PubMed 33753671Singh 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.
PubMed 33745861Nils 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.
PubMed 37886924Mohd 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.
PubMed 31909011Mohamed, 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.
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.
PubMed 35911819Hashim, 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.
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.
PubMed 28144599Dongol 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.
PubMed 25843816Dergin, G., Emes, Y. & Aybar, B. 2019. Evaluation and management of mandibular fracture. Trauma in dentistry. https://www.intechopen.com/chapters/65088.
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.
PubMed 28811076Sugragan 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.
PubMed 33195806
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness of Submucosal Dexamethasone and Methylprednisolone in Management of Postoperative Sequelae in Mandibular Parasymphysis Fractures
- ClinicalTrials.gov ID
- NCT07208799
- Acronym / sponsor ID
- U1111-1329-2007
- Keywords
- mandible fracture, edema, pain, submucosal, dexamethasone, methylprednisolone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Nishtar Medical UniversityUniversity, hospital or other
- Study start
- 3 Jan 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone group | Active comparator | Drug: DexamethasoneIn this study dexamethasone sodium phosphate 8 mg (2 mL) will be administered submucosally at the surgical site 30 minutes before incision. |
| Methylprednisolone group | Active comparator | Drug: Methylprednisolone (Corticosteroid)In this study methylprednisolone sodium succinate 40 mg (2 mL) will be administered submucosally at the surgical site 30 minutes before incision. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged 18 to 40.
- Both Gender.
- Fracture less than a week old.
- Isolated mandibular parasymphysis fractures.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasonesingle dose of dexamethasone 8 mg (2 mL) administered submucosally at the surgical site 30 minutes before incision. | Drug | Dexamethasone group |
| Methylprednisolone (Corticosteroid)a single dose of methylprednisolone 40 mg (2 mL) will be administered submucosally at the surgical site 30 minutes before incision. | Drug | Methylprednisolone group |
Primary outcome
facial Edema
Time frame: at baseline, 24 hours and 72 hours after surgery
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)
pain intensity
Time frame: at baseline, 24 hour and 72 hour postoperatively
: 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
2 secondary outcomes
serum C-reactive protein (inflammation)
Time frame: baseline, 24- and 72-hours post-op
rescue analgesia
Time frame: 24 hour to 72 hour after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Background: PubMed 25961614Salgia 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: PubMed 33753671Saravanan 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: PubMed 33745861Singh 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: PubMed 37886924Nils 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: PubMed 31909011Mohd 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.
- BackgroundMohamed, 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: PubMed 35911819Kandamani 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.
- BackgroundHashim, 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: PubMed 28144599Gadicherla 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: PubMed 25843816Dongol 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.
- BackgroundDergin, G., Emes, Y. & Aybar, B. 2019. Evaluation and management of mandibular fracture. Trauma in dentistry. https://www.intechopen.com/chapters/65088.
- Background: PubMed 28811076Chugh 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr amjad ali Bari, M.D.S (OMFS) study director
NISHTAR INSITUTE OF DENTISTRY, MULTAN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone and Methylprednisolone (Corticosteroid) in people with Mandible Fracture and Edema Face, run by Nishtar Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ammar ali khalid, Bachelor of dental surgery (923129216146, ammaraligoraya@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
facial Edema (time frame: at baseline, 24 hours and 72 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07208799, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.