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Computer Guided Screw Holes Locating Guide and Custom-made Plates

Primary Purpose

Mandibular Fractures

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
computer guided screw holes locating guide and custom-made plates
conventional plates
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mandibular Fractures focused on measuring parasymphseal mandibular fractures

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. 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.

Sites / Locations

  • Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

computer guided plates

conventional plates

Arm Description

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

conventional plate osteosynthesis in management of parasymphseal mandibular fracture

Outcomes

Primary Outcome Measures

computer tomoghraphy
the Computer Tomography Will calculate the segments deviation in mm.

Secondary Outcome Measures

Full Information

First Posted
December 5, 2022
Last Updated
December 9, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05647460
Brief Title
Computer Guided Screw Holes Locating Guide and Custom-made Plates
Official Title
Precision of Computer Guided Screw Holes Locating Guide and Custom-made Plates vs Conventional Plate Osteosynthesis in Management of Parasymphseal Mandibular Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Interventions 26 patients involved in this study will be divided in to two different groups, first group will be reduced using patient computer guided specific screw holes locating guide and custom-made plates. Second group fractures will be reduced by conventional work flow. Clinical evaluation: A through medical and dental history followed by clinical examination was carried out for all patients. Clinical measurements were taken to ensure patient adherence to our initial inclusion criteria prior to further investigations. A preoperative digital panoramic radiograph with 1:1 magnification was taken for each patient as a primary survey in order to exclude the presence of any lesion at the area of interest nor segment loss followed by A pre-operative CT. 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. Intra operative procedures for both groups: • In both group: the operation will under general anesthesia with nasal intubation and oral pack, Injection of 20 cc saline adrenaline 1:00000 to 0 in the sulcus for hemostasis, Vestibular mucosal incision followed by mentalis incision in 2 planes and ensure enough cough for latter muscle suturing, Reflect the flap to visualize the broken segments. In first group: 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. In second group: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mandibular Fractures
Keywords
parasymphseal mandibular fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
computer guided plates
Arm Type
Active Comparator
Arm Description
computer guided screw holes locating guide and custom-made plates in management of parasymphseal mandibular fracture
Arm Title
conventional plates
Arm Type
Active Comparator
Arm Description
conventional plate osteosynthesis in management of parasymphseal mandibular fracture
Intervention Type
Procedure
Intervention Name(s)
computer guided screw holes locating guide and custom-made plates
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
conventional plates
Intervention Description
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.
Primary Outcome Measure Information:
Title
computer tomoghraphy
Description
the Computer Tomography Will calculate the segments deviation in mm.
Time Frame
3 months .

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed abdellatif tageldin ahmed
Phone
00201119720141
Email
ahmed.tageldeen@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Hussien hatem
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed omara
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
mona el hadidy
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
002
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
cairo university

12. IPD Sharing Statement

Links:
URL
http://pubmed.ncbi.nlm.nih.gov/24021623/
Description
Description Reginald H.B. Goodday/Management of Fractures of the Mandibular Body and Symphysis. Oral Maxillofacial Surg Clin North Am. 2013 Nov;25
URL
http://pubmed.ncbi.nlm.nih.gov/26163841/.
Description
Evaluation of the Accuracy of Computer-Guided Mandibular Fracture Reduction. 2015 Jul;26(5):1587-91.doi: 10.1097/ SCS.0000000000001773.
URL
http://pubmed.ncbi.nlm.nih.gov/29710318/
Description
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
URL
http://pubmed.ncbi.nlm.nih.gov/20537782/
Description
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

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Computer Guided Screw Holes Locating Guide and Custom-made Plates

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