NCT06005467

Brief Summary

assessing fixation of mandibular angle fracture using two different mini plates, the standard champy technique and the new V shaped plate with comparing occlusion and condylar position between the two plates.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 6, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

July 6, 2023

Last Update Submit

August 17, 2023

Conditions

Fractures, Bone

Keywords

champyangle fracture

Outcome Measures

Primary Outcomes (1)

  • proper occlusion

    It's Clinically assessed outcome. Follow up will be carried out immediate post-operative (after1 week), 3months and after 6 months for general clinical assessment of the patient including proper occlusion.

    1 week- 3 months and 6 months

Secondary Outcomes (1)

  • condylar position

    6 months

Study Arms (2)

V shaped plate

EXPERIMENTAL

its a new plate that have been used in fixation of fractures in various areas of the mandible,V shaped plate was used in the treatment of three angle fracture cases which provided the advantage of including both lines of osteosynthesis which are the superior border and the lateral surface of the external oblique ridge using one plate.

Procedure: Open reduction and internal fixation of mandibular angle fracture using V shaped plate

champy technique

ACTIVE COMPARATOR

champy technique is one of the standard methods that are used in fixation of mandibular angle fractures by applying a mini-plate in the superior border of the external oblique ridge.

Procedure: Open reduction and internal fixation of mandibular angle fracture using V shaped plate

Interventions

Open reduction and internal fixation of mandibular angle fracture using V shaped platePROCEDURE

its a new plate that have been used in fixation of fractures in various areas of the mandible,V shaped plate was used in the treatment of three angle fracture cases which provided the advantage of including both lines of osteosynthesis which are the superior border and the lateral surface of the external oblique ridge using one plate.

V shaped platechampy technique

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with unilateral angle fracture.
  • Patients free from any systemic diseases that affect bone healing.
  • No sex predilection.
  • Age 18-50

You may not qualify if:

  • Comminuted angle fractures.
  • Infected angle fracture.
  • Bilateral angle fracture.
  • Patients with any systemic diseases that affect bone healing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry , Cairo university

Cairo, 12311, Egypt

Location

Related Publications (2)

  • Bhagat MJA, Durairaj D, Naganathan V, Nathiya B, Kumar GS, Mariam S. Application of Anatomically Designed 2-Dimensional V Plate in Management of Mandible Fracture: A Pilot Study. J Maxillofac Oral Surg. 2022 Dec;21(4):1363-1368. doi: 10.1007/s12663-021-01558-5. Epub 2021 Apr 23.

    PMID: 36896057BACKGROUND

  • Lee JH. Treatment of Mandibular Angle Fractures. Arch Craniofac Surg. 2017 Jun;18(2):73-75. doi: 10.7181/acfs.2017.18.2.73. Epub 2017 Jun 26.

    PMID: 28913310BACKGROUND

MeSH Terms

Conditions

Fractures, Bone

Interventions

Open Fracture Reduction

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Central Study Contacts

Rasha Tohamy, BSc.

CONTACT

01066534079rasha.tohamy@dentistry.cu.edu.eg

Alaa Hassan, BSc.

CONTACT

01090101125alaa.hassan@dentistry.cu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's degree candidate

Study Record Dates

First Submitted

July 6, 2023

First Posted

August 22, 2023

Study Start

August 1, 2023

Primary Completion

August 1, 2024

Study Completion

January 1, 2025

Last Updated

August 22, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)