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Computer-Aided Design/Manufacturing for Le Fort I Osteotomy and 3D-customized Titanium Plate in Orthognathic Surgery

Assessment Of Computer-Aided Design/Manufacturing for Le Fort I Osteotomy and 3D-customized Titanium Plate in Orthognathic Surgery (Clinical Trial)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06317012
Enrollment
8
Registered
2024-03-19
Start date
2022-05-01
Completion date
2023-06-30
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Le Fort; I

Brief summary

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.

Interventions

PROCEDURELe Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate

Le Fort I osteotomy will be performed with the aid of a surgical guide through the mucosal incision at the maxillary vestibule region, providing adequate surgical exposure. The planned position will be obtained using a customized titanium plate for precise maxillary position and fixation as planned virtually on the software.

Sponsors

Hams Hamed Abdelrahman
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in pain2nd and 7th dayspain will be scored using visual analogue scale. it ranges from 0 to 10, 0 mean no pain and 10 means severe pain
change in edema2nd and 7th daysit 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.
Change in post operative osteotomy positionImmediate post operativeComputed tomography (CT) will be used immediately postoperative to assess surgical position by comparing the clinical results with the virtually planned outcome.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026