Specific Screw Holes Locating Surgical Guide and Pre-bent Plates

Precision of Patient Specific Screw Holes Locating Surgical Guide and Pre-bent Plates Osteosynthesis Versus Classical Work-flow in Management of Class III Mandibular Fractures

The aim of the current study was to evaluate the accuracy of computer-guided mandibular fracture reduction versus the classical work flow

Study Overview

• Status: Not yet recruiting
• Conditions: Mandibular Fractures
• Intervention / Treatment: Device: specific screw holes locating surgical guide and pre-bent plates; Device: classical reduction and internal fixation.

Detailed Description

Research question:

Does the use of screw holes locating surgical guide & pre-bent plates osteosynthesis accurately reduce class III mandibular fractures regarding segments integrity and occlusion more than the classical reduction and fixation?

Statement of the problem:

Mandibular fractures are the most frequently occurring fractures within the maxillofacial injuries. The evaluation, diagnosis, and management of these fractures remain challenging despite improved imaging technology and fixation techniques. Depending on the type and location of the fractures, various open and closed surgical reduction techniques can be utilized. There are several critical and inherent limitations to the current ,standard approach of mandibular fracture reduction and fixation includes : (improper alignment of segments ,malocclusion ,nerve affections and related teeth roots injury).

There is a possibility to overcome these limitations with the help of computer-guided surgery . The introduction of CAD/CAM software has provided surgeons with an opportunity to perform virtual manipulations of CT datasets preoperatively and production of corrected mandibular model for plate pre-bending and fabrication of plate locating surgical guide which provide accurate segment reduction and fixation with accurate post-operative occlusion and minimal post-operative complication . The aim of the current study was to evaluate the accuracy of computer-guided mandibular fracture reduction versus the conventional work flow

Rationale for conducting the research:

Through computer guided mandibular fracture reduction investigators can provide proper segment alignment with subsequent accurate post-operative occlusion in addition reduce intra-operative time , post-operative pain and edema

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: abdallah gaber; Phone Number: 01155778958; Email: abdallahgaber@dentistry.cu.edu.eg
• Study Contact Backup: Name: Hussein Hatem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with delayed and isolated mandibular class III fracture needs open reduction and internal fixation.
• Patients with medical history that did not hinder plate placement (uncontrolled diabetes) and adequate proper oral hygiene.
• Both genders males and females will be included.

Exclusion Criteria:

• • General contraindications to surgery.

  • Patients with fresh fractures (mobile segments).
  • Patients with unfavourable nor comminuted fractures.
  • Subjected to irradiation in the head and neck area less than 1 year before fixation.
  • Untreated periodontitis.
  • Poor oral hygiene and motivation.
  • Uncontrolled diabetes.
  • Pregnant or nursing.
  • Substance abuse.
  • Psychiatric problems or unrealistic expectations.
  • Severe bruxism or clenching.
  • Immunosuppressed or immunocompromised.
  • Treated or under treatment with intravenous amino-bisphosphonates.
  • Patients participating in other studies, if the present protocol could not be properly followed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: specific screw holes locating surgical guide and pre-bent plates; Put the specific screw holes locating device in place and drill the screw holes, remove the screw holes locating device and mobilize the segments then apply the pre-bent plates and fix it with screw for passive reduction of the segments. Then suture the mentalis muscle then the mucosa.	Device: specific screw holes locating surgical guide and pre-bent plates; Put the specific screw holes locating device in place and drill the screw holes, remove the screw holes locating device and mobilize the segments then apply the pre-bent plates and fix it with screw for passive reduction of the segments. Then suture the mentalis muscle then the mucosa.
Other: classical reduction and fixation; mobilize the broken segment first, Arch bar was made to achieve proper occlusion put the compression plate on the inferior border and remove it for further bending using plate pliers for further accommodation of the plate on the inferior border the fix it in place using compression and tension plate.	Device: classical reduction and internal fixation.; mobilize the broken segment first, Arch bar was made to achieve proper occlusion put the compression plate on the inferior border and remove it for further bending using plate pliers for further accommodation of the plate on the inferior border the fix it in place using compression and tension plate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
computer tomography	the Computer Tomography Will calculate the segments deviation in mm. after 3 month .	after 3 months

Collaborators and Investigators

• Sponsor: Abdallah Gaber Ali Mohamed
• Investigators: Study Director: mona el hadidy, Cairo University; Study Director: Mohammed Omara, Cairo University

Publications and helpful links

Helpful Links

• Reginald H.B. Goodday/Management of Fractures of the Mandibular Body and Symphysis. Oral Maxillofacial Surg Clin North Am. 2013 Nov;25
• Evaluation of the Accuracy of Computer-Guided Mandibular Fracture Reduction. 2015 Jul;26(5):1587-91.doi: 10.1097/SCS.0000000000001773.
• Parul Sinha , Gary Skolnick , Kamlesh B Patel , Gregory H Branham , John J Chi /A 3-Dimensional-Printed Short-Segment Template Prototype for Mandibular Fracture Repair. 2018 Sep 1;20(5):373-380
• Comparison of 3D plate and locking plate in treatment of mandibular fracture-a clinical study. Oral Maxillofacial Surg 2017 Dec;21(4)
• Scott Lovald , Bret Baack, Curtis Gaball, Garth Olson, Anna 31 Hoard/Biomechanical optimization of bone plates used in rigid fixation of mandibular symphysis fractures. 2010 Aug

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: July 1, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 1, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: class III
• Additional Relevant MeSH Terms: Nervous System Diseases; Fractures, Bone; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Skull Fractures; Mandibular Fractures
• Other Study ID Numbers: class III mandibular fractures

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No