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
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 |
- 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.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Cairo University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | computer tomoghraphy | the Computer Tomography Will calculate the segments deviation in mm. | 3 months . |
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