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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (Study group) will be treated with locating guides to reposition the maxilla with pre-bent plates | Experimental | After le fort 1 osteotomy, locating guides will be used to reposition the maxilla with pre-bent plates. |
|
| (Control group) will be treated with Intermediate wafer. | Active Comparator | After le fort 1 osteotomy, Intermediate wafer will be used with intermaxillary fixation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orthognathic surgery (lefort1) | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
| The surgery duration | The time taken between performing the Le fort 1 osteotomy till completion of plate fixation will be measured. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain | Will be assessed through a 10-point Visual Analogue Scale (VAS) | after one week, two weeks |
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Inclusion Criteria:
Exclusion Criteria:
cleft lip and palate. skeletal disharmony due to trauma or severe facial asymmetry. significant medical condition.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria University, Faculty of dentistry | Alexandria | 21619 | Egypt |
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| ID | Term |
|---|---|
| D063169 | Dentofacial Deformities |
| ID | Term |
|---|---|
| D019767 | Maxillofacial Abnormalities |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D057909 | Orthognathic Surgery |
| ID | Term |
|---|---|
| D013515 | Surgery, Oral |
| D003813 | Dentistry |
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|
| D018640 | Stomatognathic System Abnormalities |
| D009057 | Stomatognathic Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |