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

February 25, 2025 updated by: Dina Mohamed Mohamed Abdelwahab, Faculty of Dental Medicine for Girls

Patient Specific Polyetheretherketone (PEEK) Miniplates Versus Titanium Genioplasty Plates in The Fixation of Computer-Guided Advancement Genioplasty

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12345
        • Dina mohamed abdelwahab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEEK plates in Computer guided advancement genioplasty
Study group
Procedure: computer guided advancement genioplasty
PEEK vs Titanium patient specific plates
Experimental: Titanium plates in Computer guided advancement genioplasty
Control group
Procedure: computer guided advancement genioplasty
PEEK vs Titanium patient specific plates

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stability of PEEK vs Titanium plates
Time Frame: 6 months follow up
Radiographic linear discrepancy in mm (Horizontal and vertical) between Pogonion and Menton position in immediate and 6 months postoperative
6 months follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 6 months
Number from 1 to 5 of a 5-point Likert scale (1 very dissatisfied is minimal to 5 very satisfied is maximum)
6 months
Cost of patient specific plated (PEEK and titanium)
Time Frame: 6 months
Number in Egyptian pound
6 months
Soft tissue healing
Time Frame: 6 months
Binary answer (yes if happened or no if not happened) of clinical examination (Infection, soft tissue dehiscence and plate exposure)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculty of Dental Medicine for Girls

Investigators

  • Study Director: Nahed Adly, consultant, Assistant professor at faaculty of dentistry AlAzhar university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2018

Primary Completion (Actual)

March 2, 2024

Study Completion (Actual)

October 1, 2024

Study Registration Dates

First Submitted

February 12, 2025

First Submitted That Met QC Criteria

February 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORSUR-108-2-L

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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