Assessment Of Computer-Aided Design/Manufacturing for Le Fort I Osteotomy and 3D-customized Titanium Plate in Orthognathic Surgery (Clinical Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Change in pain
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- All
- Accepts 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.
- •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
Arms & Interventions
Le Fort I osteotomy
Intervention: Le Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate (Procedure)
Outcomes
Primary Outcomes
Change in pain
Time Frame: 2nd and 7th days
pain will be scored using visual analogue scale. it ranges from 0 to 10, 0 mean no pain and 10 means severe pain
Change in post operative osteotomy position
Time Frame: Immediate post operative
Computed tomography (CT) will be used immediately postoperative to assess surgical position by comparing the clinical results with the virtually planned outcome.
change in edema
Time Frame: 2nd and 7th days
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University