Patient Specific PEEK Versus Titanium Patient Specific Plates in The Fixation of Computer-Guided Advancement Genioplasty

NCT ID: NCT06838533

Last Updated: 2025-02-27

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

2018-03-03

Study Completion Date

2024-10-01

Brief Summary

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Evaluation of polyetheretherketone (PEEK) versus titanium patient specific plates in the fixation of computer-guided advancement genioplasty.

Detailed Description

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Aim: Comparison between polyetheretherketone (PEEK) and titanium patient specific plates in the fixation of computer-guided advancement genioplasty.

Patients and Methods: This study included fourteen patients indicated for advancement genioplasty. Patients were assigned randomly into one of two equal groups. Group A (Control group) included seven patients who were treated by computer guided advancement genioplasty using patient specific titanium plates and Group B(Study group) involved seven patients who were treated by computer guided advancement genioplasty using patient specific PEEK plates.

Conditions

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Mandible; Deformity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PEEK plates in Computer guided advancement genioplasty

Study group

Group Type EXPERIMENTAL

computer guided advancement genioplasty

Intervention Type PROCEDURE

PEEK vs Titanium patient specific plates

Titanium plates in Computer guided advancement genioplasty

Control group

Group Type EXPERIMENTAL

computer guided advancement genioplasty

Intervention Type PROCEDURE

PEEK vs Titanium patient specific plates

Interventions

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computer guided advancement genioplasty

PEEK vs Titanium patient specific plates

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients who are indicated to advancement genioplasty.
* Patients with completed growth.
* Physically and psychologically able to tolerate surgical procedures.

Exclusion Criteria

* Presence of any medical conditions that contraindicate the surgical procedure.
* Any medical condition that compromises the healing and surgical outcome.
Minimum Eligible Age

17 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Faculty of Dental Medicine for Girls

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dina Mohamed Mohamed Abdelwahab

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nahed Adly, consultant

Role: STUDY_DIRECTOR

Assistant professor at faaculty of dentistry AlAzhar university

Locations

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Dina mohamed abdelwahab

Cairo, , Egypt

Site Status

Countries

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Egypt

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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ORSUR-108-2-L

Identifier Type: -

Identifier Source: org_study_id

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