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Completed

NCT Number: NCT06838533

Patient Specific PEEK Versus Titanium Patient Specific 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.

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Key information

Conditions

Mandible; Deformity Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Age range

17 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dina mohamed abdelwahab

Cairo, 12345, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

computer guided advancement genioplasty

Procedure

PEEK vs Titanium patient specific plates

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. Cost of patient specific plated (PEEK and titanium)

    Time frame: 6 months

    Number in Egyptian pound

  3. 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)

Sponsors and collaborators

Lead sponsor

Faculty of Dental Medicine for Girls

Other Gov

Registry information

Official study title

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

Acronym: PEEK

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Feb 20, 2025
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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