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Comparison Between Prebent Plates and Custom Plates After le Fort 1 in Orthognathic Surgery

Comparison of Radiographic Accuracy Between Pre-bent Titanium Plates and 3D Customized Titanium Plates After le Fort 1 Osteotomy in Orthognathic Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06188403
Acronym
customortho
Enrollment
14
Registered
2024-01-03
Start date
2023-03-15
Completion date
2023-10-20
Last updated
2024-01-03

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

Conditions

Orthognathic Surgery

Keywords

orthognathic, virtual planning, custom plates

Brief 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.

Interventions

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

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 42 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Radiographic accuracy between postoperative plan and postoperative result.one monthCone Beam Computed tomography (CBCT) is used at 1 month to assess surgical outcome by comparing the clinical results with the virtually planned outcome.

Countries

Egypt

Outcome results

None listed

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