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Hypothesis The investigators hypothesis that fixation of mandibular angle fractures using a 3D titanium miniplate will provide better occlusal bite force than intraoral fixation using the standard two-plate technique.
The investigators expect that this method will facilitate a faster recovery time for participants to regain baseline occlusion force.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fixation using standard Two plate titanium. | Active Comparator | Intervention Name: Two Standard plat titanium system . Intervention Type: Device Assigned Intervention: Fixation using two titanium miniplates. The first plate is placed at the inferior border of the mandible from the buccal side, fixed with bicortical screws engaging both cortices. The second plate is positioned ~5 mm superior or at the external oblique ridge, fixed with monocortical screws to avoid dental root injury. |
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| 3D titanium miniplate | Experimental | Intervention Name: 3D Titanium Miniplate (2.0 mm, 8-hole) Intervention Type: Device Assigned Intervention: Fixation with a single rectangular 2.0 mm 9-hole 3D titanium miniplate. Two diagonally opposite monocortical screws placed first, followed by the remaining two. The plate is contoured with crossbars perpendicular and struts parallel to the fracture line. The upper crossbar is positioned subapically. Fixation is on the lateral cortex or external oblique ridge with proper adaptation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Two Standard Plate Fixation | Device | Fixation using two titanium miniplates. One plate at the inferior border of the mandible with bicortical screws. Second plate ~5 mm above or at the external oblique ridge with monocortical screws. |
| Measure | Description | Time Frame |
|---|---|---|
| Occlusal force | use bite force measurement device . make patient bite to muser the force (, newton unit). | first day surgery , second visit 30 days , the last visit 120 days. . |
| Measure | Description | Time Frame |
|---|---|---|
| maximal incisal opening. | Ask the patient to open their mouth as wide as possible without feeling pain. Using a ruler or caliper, measure the vertical distance between the incisal edge of the upper central incisor and the incisal edge of the lower central incisor | first day surgery , second visit 30 days , the last visit 120 days. . |
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Inclusion Criteria:
• Age from 20 to 50years.
Exclusion Criteria:
• Patients with contraindication to general anesthesia
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of oral and dental medicine ,cairo university , oral and maxillodical department | Cairo | Egypt |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 21, 2025 | May 1, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 10, 2025 | Jun 17, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008337 | Mandibular Fractures |
| ID | Term |
|---|---|
| D007572 | Jaw Fractures |
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
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| 3D Titanium Miniplate (2.0 mm, 8-hole). | Device | Single 2.0 mm 9-hole 3D titanium plate fixed with monocortical screws. Plate contoured with horizontal crossbars perpendicular and vertical struts parallel to fracture line. Screws placed diagonally first. |
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| Patient satisfaction |
will be measured on a visual analogue scale (VAS) with zero being unsatisfied and ten being satisfied and happy . |
| first day surgery , second visit 30 days , the last visit 120 days. . |
| D020196 |
| Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |