NCT06838533

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2018

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

6 years

First QC Date

February 12, 2025

Last Update Submit

February 25, 2025

Conditions

Mandible; Deformity

Keywords

GenioplastyPEEKMandible deformity

Outcome Measures

Primary Outcomes (1)

  • Stability of PEEK vs Titanium plates

    Radiographic linear discrepancy in mm (Horizontal and vertical) between Pogonion and Menton position in immediate and 6 months postoperative

    6 months follow up

Secondary Outcomes (3)

  • Patient satisfaction

    6 months

  • Cost of patient specific plated (PEEK and titanium)

    6 months

  • Soft tissue healing

    6 months

Study Arms (2)

PEEK plates in Computer guided advancement genioplasty

EXPERIMENTAL

Study group

Procedure: computer guided advancement genioplasty

Titanium plates in Computer guided advancement genioplasty

EXPERIMENTAL

Control group

Procedure: computer guided advancement genioplasty

Interventions

computer guided advancement genioplastyPROCEDURE

PEEK vs Titanium patient specific plates

PEEK plates in Computer guided advancement genioplastyTitanium plates in Computer guided advancement genioplasty

Eligibility Criteria

Age17 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Presence of any medical conditions that contraindicate the surgical procedure.
  • Any medical condition that compromises the healing and surgical outcome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dina mohamed abdelwahab

Cairo, 12345, Egypt

Location

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Nahed Adly, consultant

    Assistant professor at faaculty of dentistry AlAzhar university

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 12, 2025

First Posted

February 20, 2025

Study Start

March 3, 2018

Primary Completion

March 2, 2024

Study Completion

October 1, 2024

Last Updated

February 27, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)