An interventional study of CAD/CAM patient specfifc fracture reduction/plate guide and customized 3D grid plate and Champy's techqniue in Mandibular Fractures, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
This proposed study aims at creating a computer designed patient specific device and titanium plates, that are 3D manufactured in accordance to a preoperative computer aided virtual surgical procedure, aiming to obtain proper alignment of fractured segments of the lower jaw and restore proper teeth positioning therefore overcoming the possible complications of the conventional methods.
Recruited participants will be randomly allocated to a treatment groupp, whether the novel method group or a standard treatment group.
Preoperative panoramic radiograph and a Computed tomography scan will be obtained for each patient.
Surgical procedure will be conducted unde general anesthetic. Medications will be prescribed after surgery and instructions will be given to each patient.
Follow up will be on a weekly basis for the first 6 weeks followed by a followup visit once a month for 6 months.
Postoperative panoramic radiograph and a Computed tomography scan will be obtained at 1 week after the surgical procrdure and again 6 months later.
Digital data obtained from computed tomography scans along with clinical data will be analysed and studied to determine the accuracy of the computer aided device and for comparison with the standard method of treatment.
81 studies on the registry are indexed under Mandibular Fractures; 20 are open to participants now.
This study's enrollment of 24 is close to the median of 22 across 62 interventional studies indexed under Mandibular Fractures.
Browse Mandibular Fractures studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Mandibular angle fracture reduction and fixation using digitally designed and fabricated patient specific fracture reduction/plate positioning guide and customized 3D grid plate
Procedure: CAD/CAM patient specfifc fracture reduction/plate guide and customized 3D grid plate
Mandibular angle fracture reduction and fixation using a single superior border 2.0 miniplate
Procedure: Champy's techqniue
Mandibular angle fracture reduction and fixation using digitally designed and fabricated patient specific fracture reduction/plate positioning guide and customized 3D grid plate
Mandibular angle fracture reduction and fixation using a single superior border 2.0 miniplate
Guide accuracy in repositioning of the fractured segments and in comparison to the preoperative 3D virtual surgical plan.
Accuracy of postoperative reduction by superimposition of 3D CT data on a 3D specialized software
Time frame: Outcome will be assessed with preoperative CT (T1-Week 1)immediate postoperative CT at (T3-Week 3)
Postoperative occlusion
Assessment of postoperative occlusion clinically using a millimeter caliper, occlusion will be categorized into; satisfactory (no gap), mild derangement (gap of 1-2 mm) and deranged (gap more than 2 mm)
Time frame: Outcome will be assessed clinically at T2 (Week 2) and T3 (Week 3)
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cairo University