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

NCT06188403 | Completed

• 1 other identifier: Orthognathic2
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthognathic Surgery

Keywords

orthognathic; virtual planning; custom plates

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

ACTIVE COMPARATOR

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.

Procedure: Orthognathic surgery (lefort1)

(group 2) will be treated with prebent titanium plates

ACTIVE COMPARATOR

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.

Procedure: Orthognathic surgery (lefort1)

Interventions

Orthognathic surgery (lefort1) PROCEDURE

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

Also known as: Dentofacial surgery

(group 2) will be treated with prebent titanium plates; (group one) will be treated with custom titanium plates and guide to reposition the maxilla

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with non-syndromic dentofacial deformity requiring Le Fort I with or without bimaxillary osteotomy.

You may not qualify if:

• Patients with acute infection at 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University, Faculty of dentistry

Alexandria, 21619, Egypt

Location

MeSH Terms

Interventions

Orthognathic Surgery

Intervention Hierarchy (Ancestors)

Surgery, Oral; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2023
• First Posted: January 3, 2024
• Study Start: March 15, 2023
• Primary Completion: September 1, 2023
• Study Completion: October 20, 2023
• Last Updated: January 3, 2024

Record last verified: 2023-12

Locations

EG (1)