Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05647460
Other study ID # 3922
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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 .
See also
  Status Clinical Trial Phase
Completed NCT04396054 - Comparison of Double Y-shaped Plates and Lag Screws in Fixation of Anterior Mandibular Fractures N/A
Completed NCT05401994 - Screw Retained Arch Bar Versus Conventional Erich's Arch Bar in Maxillomandibular Fixation N/A
Recruiting NCT06392204 - CAD/CAM Angle Fracture Reduction/Plate Guide and Customized 3D Grid Plate Versus Champy's Technique N/A
Not yet recruiting NCT03714035 - Measurement of Mandibular Radio Morphometric Indices in Egyptian Population at Different Ages
Completed NCT04719325 - Herbert Screw vs Lag Screw Fixation in Anterior Mandibular Fracture Treatment N/A
Active, not recruiting NCT04443998 - Mandibular Fracture Reduction Using Bone Reduction Forceps N/A
Terminated NCT03849898 - Patients 60 Years and Older Suffering From Mandibular Fractures Registry
Completed NCT03938584 - The Effect of Vitamin C on Wound Healing In Mandibular Fracture Patients N/A
Completed NCT04931056 - A Post Market Clinical Follow-up Study on Biomet Microfixation HTR PEKK (Midface), Facial & Mandibular Plates.
Completed NCT03494309 - Open Versus Closed Reduction of Mandibular Sub-Condylar Fractures N/A
Not yet recruiting NCT06338982 - Fracture Pattern Following Bilateral Sagittal Split Osteotomy With or Without Impacted Third Molars N/A
Completed NCT05467618 - Comparison of Surgical Approaches in Reducing Mandibular Angle Fracture N/A
Completed NCT04985461 - Minimally Invasive Dental Occlusion Ties
Completed NCT03075865 - A Cohort Study for Clinical Evaluation of OmniMax MMF System
Recruiting NCT03405389 - Focused Registry to Collect Clinical Data on the MatrixWAVE System
Not yet recruiting NCT03608891 - Patient Specific Plates Versus Conventional Miniplates for Treatment of Mandibular Body Fractures N/A
Not yet recruiting NCT05444829 - Specific Screw Holes Locating Surgical Guide and Pre-bent Plates N/A
Completed NCT04283981 - Comparison of Operating Room Time Length With the Use of Virtual Surgical Planning Versus Conventional Treatment of Mandible Fractures N/A
Completed NCT02081885 - Tricalcium Phosphate and Chitosan as Bone Regenerator Versus Autologous Graft in Surgery for Mandibular Fracture Phase 3
Completed NCT06323122 - A Comparative Study Between Three Different Plating Techniques in Management of Mandibular Parasymphyseal Fractures.