NCT06323122

Brief Summary

The main goal in management of mandibular fractures is to restore the pre-injury form and function, with the least disability and shortest recovery period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

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

January 1, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 21, 2024

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

2.7 years

First QC Date

March 15, 2024

Last Update Submit

March 20, 2024

Conditions

Keywords

parasymphysealmandibular fractureinternal fixationminiplates3D miniplate

Outcome Measures

Primary Outcomes (1)

  • Surgery Time

    measure the time of surgery from incision till closure with minutes

    intraoperative

Secondary Outcomes (2)

  • complication

    6 months

  • fracture stability

    6 months

Study Arms (3)

group (I)

ORIF was done using two 2.0 miniplates

Device: 2.0 miniplates

Group II

ORIF was done using 2.3 high profile miniplates

Device: 2.3 high profile miniplates

Group III

ORIF was done using 3D miniplates.

Device: 3D miniplates

Interventions

2.0 miniplates

group (I)

2.3 high profile miniplates

Group II

3D miniplates

Group III

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

patients who had suffered from a recent mandibular fractures in the symphyseal or parasymphyseal region which required Open Reduction with Internal Fixation (ORIF)

You may qualify if:

  • Patients with symphyseal/ parasymphyseal mandibular fracture.
  • Patients presenting within 7 days of trauma.

You may not qualify if:

  • Associated fractures that could affect occlusion or dimensions
  • Medically compromised patients who are unfit for management under General Anesthesia
  • Patients with gross infection at the site of fracture
  • Patients not willing to return for follow-up
  • Patients with associated bone pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October 6U

Cairo, 12566, Egypt

Location

Related Publications (1)

  • Hu W, Agrawal M, Thadani S, Mukul SK, Sood R, Patel A, Dhanak R, Tailor S. Comparative evaluation of a single 2.0-mm AO locking reconstruction plate with conventional miniplate osteosynthesis for treatment of linear non-comminuted fractures of symphysis and parasymphsis region of the mandible. J Stomatol Oral Maxillofac Surg. 2019 Feb;120(1):11-15. doi: 10.1016/j.jormas.2018.10.002. Epub 2018 Oct 26.

    PMID: 30739640BACKGROUND

MeSH Terms

Conditions

Mandibular Fractures

Condition Hierarchy (Ancestors)

Jaw FracturesMaxillofacial InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesSkull FracturesFractures, BoneWounds and Injuries

Study Officials

  • Nermine Ramadan Mahmoud, PhD

    Associated Professor of oral and maxillofacial surgery, Oral Surgery Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor of oral and maxillofacial surgery, Oral Surgery Department

Study Record Dates

First Submitted

March 15, 2024

First Posted

March 21, 2024

Study Start

January 1, 2021

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

March 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations