Le Fort; I Clinical Trial
Official title:
Assessment Of Computer-Aided Design/Manufacturing for Le Fort I Osteotomy and 3D-customized Titanium Plate in Orthognathic Surgery (Clinical Trial)
NCT number | NCT06317012 |
Other study ID # | 0407-03/2022 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2022 |
Est. completion date | June 30, 2023 |
Verified date | March 2024 |
Source | Alexandria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: In orthognathic surgery, virtual planning is gradually taking over in clinical practice. To start with, virtual surgery planning (VSP) is believed to be less time-consuming and less expensive than conventional surgery planning (CSP). Moreover, the improved visualization of craniofacial deformities, such as occlusal canting and asymmetries, is a further advantage. Aim: To assess the result of Le Fort I osteotomy using CAD/CAM and 3Dcustomized titanium plate with virtual planning in orthognathic surgery. Materials and Methods: 8 patients with vertical maxillary excess will be included in the study. Le Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate will be done for the study group. All patients will be followed clinically and radiographically for one month.
Status | Completed |
Enrollment | 8 |
Est. completion date | June 30, 2023 |
Est. primary completion date | May 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 40 Years |
Eligibility | Inclusion Criteria: - Patients with non-syndromic dentofacial deformity requiring isolated Le Fort I with or without bimaxillary osteotomy. - Patients with good oral hygiene. - Class II or III malocclusion. - Patients who were scheduled to undergo a CT scan as a part of their diagnosis and treatment Exclusion Criteria: - Patients with acute infection at the surgery site. - Patient with Systemic disorders contraindicating surgery. - Smokers. - Alcohol or drug abuse is prohibited. - patients who suffered from craniofacial syndrome; - patients who had previous orthognathic surgery; - patients who had previous maxillary or mandibular trauma |
Country | Name | City | State |
---|---|---|---|
Egypt | Alexandria Faculty of Dentistry | Alexandria |
Lead Sponsor | Collaborator |
---|---|
Hams Hamed Abdelrahman |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in pain | pain will be scored using visual analogue scale. it ranges from 0 to 10, 0 mean no pain and 10 means severe pain | 2nd and 7th days | |
Primary | change in edema | it was evaluated by its ability to pit. The examiner's fingers will press into the dependent area for 5 seconds, and the pitting will be graded on a scale of +1 to+4. | 2nd and 7th days | |
Primary | Change in post operative osteotomy position | Computed tomography (CT) will be used immediately postoperative to assess surgical position by comparing the clinical results with the virtually planned outcome. | Immediate post operative |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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