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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06188403
Other study ID # Orthognathic2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2023
Est. completion date October 20, 2023

Study information

Verified date December 2023
Source Alexandria University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

patients with dentofacial deformities , who needs lefort 1 osteotomy to correct position of maxilla , are divided into two groups: one group receives custom titanium plates which is patient specific and the other group receives prebent titanium plates done on printed postop plan model before surgery.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date October 20, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 42 Years
Eligibility Inclusion Criteria: - . Patients with non-syndromic dentofacial deformity requiring Le Fort I with or without bimaxillary osteotomy. Exclusion Criteria: 1. Patients with acute infection at surgery site. 2. Patient with Systemic disorders contraindicating surgery. 3. Smokers. 4. Alcohol or drug abuse is prohibited. 5. patients who suffered from craniofacial syndrome. 6. patients who had previous orthognathic surgery. 7. patients who had previous maxillary or mandibular trauma

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Orthognathic surgery (lefort1)
Lefort 1 osteotomy to reposition the maxilla using two different techniques to achieve more accurate results , one with guide for cutting and placing pre bent stock plates and the other method using custom titanium plates with guide for cutting and placing the plate

Locations

Country Name City State
Egypt Alexandria University, Faculty of dentistry Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Radiographic accuracy between postoperative plan and postoperative result. Cone Beam Computed tomography (CBCT) is used at 1 month to assess surgical outcome by comparing the clinical results with the virtually planned outcome. one month
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