Radiographic and Clinical Evaluation of Three-Dimensional Delta Plate in Internal Fixation of Mandibular Sub-condylar Fractures.

NCT07311239 | Completed DMC

• 1 other identifier: 1299
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, we intend to examine the efficacy of 3D delta plates through radiographic evaluation of anatomic reduction and vertical ramus height as the main outcome and clinical assessment of pain and range of mandibular movements as secondary outcomes. This Single arm longtudinal study will include 14 cases of trauma having mandibular sub condylar fractures, in which open reduction and internal fixation are indicated. After selecting patients according to the inclusion criteria, all patients will undergo open reduction and rigid fixation. Fracture will be stabilized using 4 hole, 2.0 mm 3-D Delta titanium plates using pre-auricular or retromandibular incision. Radiographic evaluation using Computed Topograhy (CT) scans will be carried on immediatly after the operation then 3 months post operatively. While, Clinical assessment will be performed at the following intervals after the surgery( 1 week, 1 month, 3 months)

Conditions

Mandible Fracture

Keywords

Open Reduction and Internal Fixation of unilateral sub condylar fractures of the mandible; sub condylar fractures; 3D Delta Plate

Outcome Measures

Primary Outcomes (1)

• posterior vertical height and anatomic reduction using CT

  Radiographic evaluation of posterior vertical height and anatomic reduction using CT

  3 months

Study Arms (1)

14 patients recruited to the previously mentioned departments

EXPERIMENTAL

Device: Three Dimensional Delta Plate

Interventions

Three Dimensional Delta Plate DEVICE

A 3D titanium plate designed with the following measurments: 1 mm thick, 20 mm long, 14 mm wide at the base, 5 mm wide at the apex. It has 4 holes where 2.00 mm screws can fit in.

14 patients recruited to the previously mentioned departments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at or over 18 years.
• Unilateral sub condylar fractures. -

You may not qualify if:

• Bilateral sub condylar fractures
• Pediatric patients.
• Intracapsular fractures
• Patients with Uncontrolled systematic conditions. -

Sponsors & Collaborators

• Ain Shams University: lead
• Ahmed Maher Teaching Hospital: collaborator

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Related Publications (18)

• Zachariades N, Mezitis M, Mourouzis C, Papadakis D, Spanou A. Fractures of the mandibular condyle: a review of 466 cases. Literature review, reflections on treatment and proposals. J Craniomaxillofac Surg. 2006 Oct;34(7):421-32. doi: 10.1016/j.jcms.2006.07.854. Epub 2006 Oct 19.

  PMID: 17055280 BACKGROUND

• Kang DH. Surgical management of a mandible subcondylar fracture. Arch Plast Surg. 2012 Jul;39(4):284-90. doi: 10.5999/aps.2012.39.4.284. Epub 2012 Jul 13.

  PMID: 22872829 BACKGROUND

• Ellis E 3rd, Throckmorton G. Facial symmetry after closed and open treatment of fractures of the mandibular condylar process. J Oral Maxillofac Surg. 2000 Jul;58(7):719-28; discussion 729-30. doi: 10.1053/joms.2000.7253.

  PMID: 10883686 BACKGROUND

• Tandon S, Verma V, Rashid M, Srivastava S, Singh AK, Sharma NK. Is the facial nerve at risk following surgical correction of mandibular condylar fracture: A systematic review and meta-analysis. Natl J Maxillofac Surg. 2022 Aug;13(Suppl 1):S1-S10. doi: 10.4103/njms.njms_481_21. Epub 2022 Aug 20.

  PMID: 36393942 BACKGROUND

• Nys M, Van Cleemput T, Dormaar JT, Politis C. Long-term Complications of Isolated and Combined Condylar Fractures: A Retrospective Study. Craniomaxillofac Trauma Reconstr. 2022 Sep;15(3):246-252. doi: 10.1177/19433875211026759. Epub 2021 Jun 23.

  PMID: 36081681 BACKGROUND

• Moloro Michael, Ghali G.E., Larsen PE. Peterson's Principles of Oral and Maxillofacial Surgery . fourth. 2022. 649-670 p

  BACKGROUND

• Kommers SC, Boffano P, Forouzanfar T. Consensus or controversy? The classification and treatment decision-making by 491 maxillofacial surgeons from around the world in three cases of a unilateral mandibular condyle fracture. J Craniomaxillofac Surg. 2015 Dec;43(10):1952-60. doi: 10.1016/j.jcms.2015.08.031. Epub 2015 Sep 9.

  PMID: 26498515 BACKGROUND

• Singh V, Bhagol A, Goel M, Kumar I, Verma A. Outcomes of open versus closed treatment of mandibular subcondylar fractures: a prospective randomized study. J Oral Maxillofac Surg. 2010 Jun;68(6):1304-9. doi: 10.1016/j.joms.2010.01.001. Epub 2010 Apr 3.

  PMID: 20363548 BACKGROUND

• Huang CM, Chan MY, Hsu JT, Su KC. Biomechanical analysis of subcondylar fracture fixation using miniplates at different positions and of different lengths. BMC Oral Health. 2021 Oct 21;21(1):543. doi: 10.1186/s12903-021-01905-5.

  PMID: 34674692 BACKGROUND

• Ashor M, Salah A, Shindy M, Selim H, Metwaly S, Behairy G. Clinical and radiographic outcomes of rhomboid plate in management of subcondylar fractures: prospective randomized controlled trial. Egypt. J. Oral Maxillofac. surg. 2018 Jan 1;9(1):1-5.

  BACKGROUND

• Lauer G, Haim D, Proff P, Richter G, Pradel W, Fanghanel J, Pilling E, Gedrange T, Mai R. Plate osteosynthesis of the mandibular condyle. Ann Anat. 2007;189(4):412-7. doi: 10.1016/j.aanat.2007.02.021.

  PMID: 17696004 BACKGROUND

• Albogha MH, Mori Y, Takahashi I. Three-dimensional titanium miniplates for fixation of subcondylar mandibular fractures: Comparison of five designs using patient-specific finite element analysis. J Craniomaxillofac Surg. 2018 Mar;46(3):391-397. doi: 10.1016/j.jcms.2017.12.020. Epub 2017 Dec 26.

  PMID: 29311022 BACKGROUND

• Chaudhary M, Pant H, Singh M, Vashistha A, Kaur G. Evaluation of trapezoidal-shaped 3-D plates for internal fixation of mandibular subcondylar fractures in adults. J Oral Biol Craniofac Res. 2015 Sep-Dec;5(3):134-9. doi: 10.1016/j.jobcr.2015.07.005. Epub 2015 Aug 15.

  PMID: 26587378 BACKGROUND

• Choi KY, Yang JD, Chung HY, Cho BC. Current concepts in the mandibular condyle fracture management part I: overview of condylar fracture. Arch Plast Surg. 2012 Jul;39(4):291-300. doi: 10.5999/aps.2012.39.4.291. Epub 2012 Jul 13.

  PMID: 22872830 RESULT

• Ahuja SA, Galinde J, Asnani U, Mistry YA. Comparative Evaluation of Clinical Outcomes Using Delta Plates and Conventional Miniplates for Internal Fixation of Mandibular Condylar Fractures in Adults. J Oral Maxillofac Surg. 2018 Jun;76(6):1255-1266. doi: 10.1016/j.joms.2017.12.018. Epub 2017 Dec 30.

  PMID: 29360455 RESULT

• Lata J, Verma N, Mahajan S. Evaluation of Efficacy of 3-Dimensional Delta Versus Trapezoidal Condylar Plates in Internal Fixation of Mandibular Subcondylar Fractures: A Clinical Study. The Traumaxilla. 2019 Apr;1(1):11 21.

  RESULT

• Sikora M, Sielski M, Stapor A, Chlubek D. Use of the Delta plate for surgical treatment of patients with condylar fractures. J Craniomaxillofac Surg. 2016 Jul;44(7):770-4. doi: 10.1016/j.jcms.2016.04.008. Epub 2016 Apr 15.

  PMID: 27189923 RESULT

• Sarkar A, Banerjee L, Ghosh S. Efficacy of Delta Plate in Condylar Fracture: a Case Series with Review. J Dent (Shiraz). 2023 Mar;24(1):71-75. doi: 10.30476/DENTJODS.2022.94746.1806.

  PMID: 36864994 RESULT

MeSH Terms

Conditions

Mandibular Fractures

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 30, 2025
• Study Start: November 11, 2024
• Primary Completion: July 19, 2025
• Study Completion: October 20, 2025
• Last Updated: December 30, 2025

Record last verified: 2024-11

Locations

EG (1)