Patient Specific Plates Versus Conventional Miniplates for Treatment of Mandibular Body Fractures

NCT03608891 | Unknown DMC

• 1 other identifier: Patient specific plate
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the current study is to evaluate and assess the clinical stability and efficacy of patient specific computer guided titanium plates versus the conventional titanium mini plates regarding accurate reduction and fixation of mandibular body fractures, reducing the operating time, achieving precise bone alignment and reducing the plate palpability.

Conditions

Mandibular Fractures

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction measured with visual analogue scale (0-10)

  patient satisfaction is defined as patient-reported outcome measure while the structures and processes of care can be measured by patient-reported experiences (30). Measured on a visual analogue scale (VAS) (29) of 0-10 ,with zero being unsatisfied and 10 being satisfied. Patient Satisfaction is assessed regarding prescence of pain, occlusal discrepencies and overall patient satisfaction.

  Measured immediately after the surgery

Secondary Outcomes (4)

• Fracture gap distance

  0 and 3 months

• Occlusal bite force

  0 and 3 months

• Operating time

  time of the surgery

• Plate palpability

  0 and 3 months

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

Conventional titanium miniplates

Device: Conventional titanium miniplates

Intervention arm

EXPERIMENTAL

Patient specific 3D plates

Device: Computer guided patient specific 3D titanium plate

Interventions

Computer guided patient specific 3D titanium plate DEVICE

CBCT or CT scan will be done preoperatively and dicom files will be imported to mimics software to design and print the patient specific 3D titanium plate.

Also known as: Intervention Arm

Intervention arm

Conventional titanium miniplates DEVICE

In this group two miniplates of titanium Mini-System 2.0 mm will be used. The plate has profile height 1.0 mm whereas the screw length varies according to the site of the plate. According to Champy osteosynthesis lines for fixation of the posterior mandibular fracture ,the first plate will be placed at the inferior border from the buccal side, using bicortical screws engaging the buccal and lingual cortices to achieve rigid fixation, while the second plate will be placed at about 5mm superior to the inferior plate in the subapical region, using monocortical screws engaging only the buccal cortex to avoid injuring the teeth roots.

Also known as: Control arm

Control Arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with unilateral mandibular body fractures, not associated with other mandibular and maxillofacial fractures

You may not qualify if:

• Patients with bilateral mandibular fractures
• Patients with other mandibular or maxillofacial fractures
• Comminuted fractures
• Medical problem that may interfere with the procedure such as bleeding disorder and pregnancy.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (13)

• Perez R, Oeltjen JC, Thaller SR. A review of mandibular angle fractures. Craniomaxillofac Trauma Reconstr. 2011 Jun;4(2):69-72. doi: 10.1055/s-0031-1272903.

  PMID: 22655117 BACKGROUND

• Goiato MC, Santos MR, Pesqueira AA, Moreno A, dos Santos DM, Haddad MF. Prototyping for surgical and prosthetic treatment. J Craniofac Surg. 2011 May;22(3):914-7. doi: 10.1097/SCS.0b013e31820f7f90.

  PMID: 21558926 BACKGROUND

• Levine JP, Patel A, Saadeh PB, Hirsch DL. Computer-aided design and manufacturing in craniomaxillofacial surgery: the new state of the art. J Craniofac Surg. 2012 Jan;23(1):288-93. doi: 10.1097/SCS.0b013e318241ba92.

  PMID: 22337427 BACKGROUND

• Talwar RM, Chemaly D. Information and computer technology in oral and maxillofacial surgery. Oral Maxillofac Surg Clin North Am. 2008 Feb;20(1):79-89. doi: 10.1016/j.coms.2007.09.006.

  PMID: 18194740 BACKGROUND

• Edwards SP. Computer-assisted craniomaxillofacial surgery. Oral Maxillofac Surg Clin North Am. 2010 Feb;22(1):117-34. doi: 10.1016/j.coms.2009.11.005.

  PMID: 20159482 BACKGROUND

• Hassfeld S, Muhling J. Computer assisted oral and maxillofacial surgery--a review and an assessment of technology. Int J Oral Maxillofac Surg. 2001 Feb;30(1):2-13. doi: 10.1054/ijom.2000.0024.

  PMID: 11289616 BACKGROUND

• Eckardt A, Swennen GR. Virtual planning of composite mandibular reconstruction with free fibula bone graft. J Craniofac Surg. 2005 Nov;16(6):1137-40. doi: 10.1097/01.scs.0000186306.32042.96.

  PMID: 16327572 BACKGROUND

• Bell RB. Computer planning and intraoperative navigation in cranio-maxillofacial surgery. Oral Maxillofac Surg Clin North Am. 2010 Feb;22(1):135-56. doi: 10.1016/j.coms.2009.10.010.

  PMID: 20159483 BACKGROUND

• Al-Abri R, Al-Balushi A. Patient satisfaction survey as a tool towards quality improvement. Oman Med J. 2014 Jan;29(1):3-7. doi: 10.5001/omj.2014.02.

  PMID: 24501659 RESULT

• Butts SC, Floyd E, Lai E, Rosenfeld RM, Doerr T. Reporting of Postoperative Pain Management Protocols in Randomized Clinical Trials of Mandibular Fracture Repair: A Systematic Review. JAMA Facial Plast Surg. 2015 Nov-Dec;17(6):440-8. doi: 10.1001/jamafacial.2015.1011.

  PMID: 26335408 RESULT

• Kumar ST, Saraf S, Devi SP. Evaluation of bite force after open reduction and internal fixation using microplates. J Dent (Tehran). 2013 Sep;10(5):466-77. Epub 2013 Sep 30.

  PMID: 24910656 RESULT

• Rodt T, Bartling SO, Zajaczek JE, Vafa MA, Kapapa T, Majdani O, Krauss JK, Zumkeller M, Matthies H, Becker H, Kaminsky J. Evaluation of surface and volume rendering in 3D-CT of facial fractures. Dentomaxillofac Radiol. 2006 Jul;35(4):227-31. doi: 10.1259/dmfr/22989395.

  PMID: 16798916 RESULT

• Manson PN, Markowitz B, Mirvis S, Dunham M, Yaremchuk M. Toward CT-based facial fracture treatment. Plast Reconstr Surg. 1990 Feb;85(2):202-12; discussion 213-4.

  PMID: 2300626 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 Officials

• Mohamed A Farid, PHD

  Cairo University

  PRINCIPAL INVESTIGATOR

• Mohamed A Abd el Rasol, PhD

  Cairo University

  STUDY CHAIR

Central Study Contacts

Dina A Alei El Dine, Postgraduate

CONTACT

01285568850; dinaadelta3lab@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master degree student

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: August 1, 2018
• Study Start: July 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: July 1, 2019
• Last Updated: August 1, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share