Computer Guided Screw Holes Locating Guide and Custom-made Plates

NCT05647460 | Unknown

• 1 other identifier: 3922
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

• Preoperative CT.
• Virtual reduction of broken segments on software.
• Gain occlusion.
• Design surgical screw holes locating guide.
• Design the custom-made plates.
• Print the screw holes locating guide and the custom-made plate. under general anesthesia the parasymphseal fracture will be reduced using screw holes locating guide and the custom-made plates.

Conditions

Mandibular Fractures

Keywords

parasymphseal mandibular fractures

Outcome Measures

Primary Outcomes (1)

• computer tomoghraphy

  the Computer Tomography Will calculate the segments deviation in mm.

  3 months .

Study Arms (2)

computer guided plates

ACTIVE COMPARATOR

computer guided screw holes locating guide and custom-made plates in management of parasymphseal mandibular fracture

Procedure: computer guided screw holes locating guide and custom-made plates

conventional plates

ACTIVE COMPARATOR

conventional plate osteosynthesis in management of parasymphseal mandibular fracture

Procedure: conventional plates

Interventions

computer guided screw holes locating guide and custom-made plates PROCEDURE

Virtual planning and guide fabrication for the study group: * Preoperative CT. * Virtual reduction of broken segments on software. * Gain occlusion. * Design surgical screw holes locating guide. * Design the custom-made plates. * Print the screw holes locating guide and the custom-made plate. * Surgical guiding tools: screw holes locating guide and custom-made 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 custom-made plates and fix it with screw for passive reduction of the segments. Then suture the mentalis muscle then the mucosa.

computer guided plates

conventional plates PROCEDURE

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.

conventional plates

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with parasymphseal mandibular class 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.

You may not qualify if:

• • 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 002, Egypt

RECRUITING

Related Links

• Description 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
• Description 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

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 omara

  Cairo University

  STUDY DIRECTOR

• mona el hadidy

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

ahmed abdellatif tageldin ahmed

CONTACT

00201119720141; ahmed.tageldeen@dentistry.cu.edu.eg

Hussien hatem

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master degree researcher

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 12, 2022
• Study Start: October 6, 2022
• Primary Completion: September 30, 2023
• Study Completion: December 30, 2023
• Last Updated: December 12, 2022

Record last verified: 2022-09

Locations

EG (1)