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

NCT ID: NCT06188403

Last Updated: 2024-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2023-10-20

Brief Summary

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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.

Detailed Description

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Conditions

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Orthognathic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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

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.

Group Type ACTIVE_COMPARATOR

Orthognathic surgery (lefort1)

Intervention Type 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

(group 2) will be treated with prebent titanium plates

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.

Group Type ACTIVE_COMPARATOR

Orthognathic surgery (lefort1)

Intervention Type 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

Interventions

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Orthognathic surgery (lefort1)

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

Intervention Type PROCEDURE

Other Intervention Names

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Dentofacial surgery

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alexandria University, Faculty of dentistry

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Orthognathic2

Identifier Type: -

Identifier Source: org_study_id

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