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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
14
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
Alexandria University, Faculty of dentistry
Alexandria, Egypt
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
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