Computer Guided Screw Holes Locating Guide and Custom-made Plates

Mandibular Fractures Clinical Trial

Official title:

Precision of Computer Guided Screw Holes Locating Guide and Custom-made Plates vs Conventional Plate Osteosynthesis in Management of Parasymphseal Mandibular Fracture

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05647460
• Other study ID #: 3922
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: September 2022
• Source: Cairo University
• Contact: ahmed abdellatif tageldin ahmed
• Phone: 00201119720141
• Email: ahmed.tageldeen[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: December 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Mandibular Fractures

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	computer tomoghraphy	the Computer Tomography Will calculate the segments deviation in mm.	3 months .

External Links

•   Description Reginald H.B. Goodday/Management of Fractures of the Mandibular Body and Symphysis. Oral Maxillofacial Surg Clin North Am. 2013 Nov;25
•   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
•   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