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This investigation aimed to determine the clinical and radiographic efficacy of patient-specific, custom-made 3D PEEK plates in comparison with 3D titanium plates for the management of mandibular angle fractures.
Eighteen patients with recent mandibular angle fractures indicated for open reduction and internal fixation were randomly allocated into two groups. The study group (n = 9) underwent fixation with custom-made 3D PEEK plates, while the control group (n = 9) received prebent 3D titanium plates adapted on virtually reduced models. Follow-up extended to 12 weeks. Clinical parameters included operative time, postoperative occlusion, interfragmentary stability, wound healing, and bite force recovery. Radiographic evaluation was conducted using computed tomography scans acquired immediately postoperatively and at 12 weeks, assessing fracture healing and mean bone density.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with recent mandibular angle fractures managed with custome made 3D PEEK plate | Experimental | custome made 3D PEEK plate |
|
| patients with recent mandibular angle fractures managed with 3D Titanium plates | Experimental | 3D Titanium plates |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Custome made 3D PEEK plate | Device | Custome made 3D PEEK plate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic evaluation for the assessment of mean bone density at the fracture line [Time Frame: 12 weeks] | Mean bone density at the fracture line was assessed using Computed Tomography (CT) scan in Hounsfield Units (HU) | 12 weeks |
| Bite force recovery. | bite force recovery measured by a Piezoresistive force transduce sensor: FlexiForce A201 sensor (FlexiForce sensor, by Tekscan Boston, MA, USA. www.tekscan.com) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical evaluation for interfragmentary stability. | Intra-fragmentary mobility was evaluated by bimanual palpation at the fracture site | 12 weeks |
| clinical evaluation of wound healing | Wound healing is graded according to Southampton wound-grading system |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of dentistry, Alexandria university | Alexandria | 21523 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41618317 | Derived | Kamal AO, Shaaban AM, Shokry MM, Abdelhamed IM. Custom-made 3D PEEK plates versus 3D titanium plates for mandibular angle fracture fixation: a randomized clinical trial. BMC Oral Health. 2026 Jan 30;26(1):384. doi: 10.1186/s12903-025-07646-z. |
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all data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study
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Randomized controlled clinical trial
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Patients were allocated in a 1:1 ratio using an on-site computer software system with concealed allocation through sequentially numbered, opaque, sealed envelopes (SNOSE). Group A was treated with custom made 3D PEEK plates and Group B with 3D titanium plates.
| 3D Titanium plate | Device | Pre-bent 3D Titanium plate |
|
| 14 days |
| Clinical evaluation of postoperative occlusion | By checking the maximal intercuspal position (centric occlusion) to ensure proper occlusal relationship including molar relation, canine relation and midline centralization | 12 week |