Dentofacial Deformities Clinical Trial
— orthognathicOfficial title:
Comparison of Accuracy 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
Verified date | November 2023 |
Source | Alexandria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 14 |
Est. completion date | November 1, 2023 |
Est. primary completion date | October 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 42 Years |
Eligibility | Inclusion Criteria: - All patients requiring Le Fort I osteotomy will be selected including those suffering from skeletal malocclusion (Class II or Class III), midface hypoplasia or vertical maxillary excess. Exclusion Criteria: cleft lip and palate. skeletal disharmony due to trauma or severe facial asymmetry. significant medical condition. |
Country | Name | City | State |
---|---|---|---|
Egypt | Alexandria University, Faculty of dentistry | Alexandria |
Lead Sponsor | Collaborator |
---|---|
Alexandria University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | The surgery duration | The time taken between performing the Le fort 1 osteotomy till completion of plate fixation will be measured. | 1 week | |
Secondary | Postoperative Pain | Will be assessed through a 10-point Visual Analogue Scale (VAS) | after one week, two weeks |
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