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

Alexandria University

Status: Completed

Conditions: Orthognathic Surgery

Treatments: Procedure: Orthognathic surgery (lefort1)

Study type: Interventional

Funder types: Other

Identifiers

NCT06188403

Orthognathic2

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 42 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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14 participants in 2 patient groups

(group one) will be treated with custom titanium plates and guide to reposition the maxilla

Active Comparator group

Description:

7 patients are included in this arm. Le Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate are placed to reposition the maxilla according to the virtual surgical planning.

Treatment:

Procedure: Orthognathic surgery (lefort1)

(group 2) will be treated with prebent titanium plates

Active Comparator group

Description:

7 patients are included in this arm. le fort 1 osteotomy using surgical guide and pre-bent stock titanium plates are used after their adaptation on the model of postoperative plan.

Treatment:

Procedure: Orthognathic surgery (lefort1)