An interventional study of Orthognathic surgery (lefort1) in Dentofacial Deformities and Le Fort; I, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-15.
Sponsored by Alexandria University · Not applicable, Interventional, and Treatment
clinical and radiographic comparison between novel locating guide design with pre-bent titanium plates and 3d printed intermediate wafer to reposition the maxilla after Le Fort 1 osteotomy in orthognathic surgery (randomized controlled clinical trial)
Eligible patients will be allocated randomly into 2 equal groups with 7 patients in each group according to the method that will be used to reposition the maxilla by simple randomization using computer generated random numbers. Group 1 (Study group) will be treated with locating guides to reposition the maxilla with pre-bent plates on 3d model. Group 2 (Control group) will be treated with Intermediate wafer.
39 studies on the registry are indexed under Dentofacial Deformities; 15 are open to participants now.
This study's enrollment of 14 is below the median of 40 across 25 interventional studies indexed under Dentofacial Deformities.
Browse Dentofacial Deformities studies →Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
cleft lip and palate. skeletal disharmony due to trauma or severe facial asymmetry. significant medical condition.
After le fort 1 osteotomy, locating guides will be used to reposition the maxilla with pre-bent plates.
Procedure: Orthognathic surgery (lefort1)
After le fort 1 osteotomy, Intermediate wafer will be used with intermaxillary fixation.
Procedure: Orthognathic surgery (lefort1)
1. All patients will be treated under general anesthesia. 2. The surgical field will be scrubbed with povidone-iodine surgical scrub solution, followed by draping of the patient with sterile towels exposing only the area of surgery. 3. The surgical procedure of Le Fort I osteotomy will be performed which can be summarized as follows: 1. External reference marking 2. Incision and subperiosteal dissection 3. Maxillary osteotomy 4. Pterygomaxillary disjunction, 5. Septal, vomerine, and lateral nasal osteotomies 6. Down fracture 7. Mobilization of the maxilla 8. Application of stent in one group and the locating guide in the other group. 9. Maxillary fixation 10. Occlusal evaluation 11. Wound debridement and closure
Radiographic evaluation of accuracy by superimposition
Postoperative CBCT was obtained after 2 weeks of surgery for comparison with the expected position of the maxilla in the preoperative virtual plan using 3-matic software in Mimics innovation suite software package. The preoperative planned final maxillary position was compared with the actual postoperative maxillary position by superimposing both STL models on each other with anatomical points along the orbital rims and the zygomatic arch used as reference points for alignment. The N points registration tool was used to obtain the alignment. Afterwards, using trim tool all parts were trimmed except that between the plates and the maxillary teeth crowns. Then the part comparison analysis tool was used to calculate the accuracy of the superimposition of the maxillary segment using point-based analysis algorithm after 2 weeks of surgery for comparison with the expected position of the maxilla in the preoperative virtual plan using Mimics innovation suite software.
Time frame: 2 weeks
The surgery duration
The time taken between performing the Le fort 1 osteotomy till completion of plate fixation will be measured.
Time frame: 1 week
Postoperative Pain
Will be assessed through a 10-point Visual Analogue Scale (VAS)
Time frame: after one week, two weeks
This study is completed, as verified in Nov 2023. 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.
Alexandria University