V Shaped Plate Vs Champy Technique in Mandibular Angle Fractures

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06005467

Collaborator

(none)

Enrollment

Location

Arms

17.1

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fractures, Bone	Procedure: Open reduction and internal fixation of mandibular angle fracture using V shaped plate	N/A

Detailed Description

The mandible is one of the most frequent bones of the face that is susceptible to fractures because its prominent position, as it comes in the second place after nasal fractures . Mostly, such fractures are a result of trauma caused by vehicle accidents, physical altercations, industrial accidents, falls, and contact sports, males usually suffer from mandibular fractures more than females.

The angle of the mandible is the most frequent area of the mandible to be fractured after the body, the reasons behind that is the presence of a third molar especially if it was impacted one which weakens the region even more, another reason is the existence of a very thin cross sectional area compared to the anterior parts of the mandible. Most common causes of mandibular angle fractures are motor vehicle collisions and assaults or altercations.

Therefore, the aim of this study is to evaluate a novel method which is using a (v) shaped plate in fixation of mandibular angle fracture, The new (v) shaped plate have provided easy reduction and stabilized fixation along both sides of the fracture, as it has two arms that can be easily adjusted over the angle of the mandible covering both lines of osteosynthesis along the superior border and lateral surface of the external oblique ridge using a single plate.

Although champy technique has been proven to be successful way for treating angle fractures with low complication rates it covers only one line of osteosynthesis which is the superior border of external oblique ridge unlike the (v) shaped plate.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effect of (v) Shaped Plate on Occlusion and Condylar Position Compared to Champy Technique in Fixation of Mandibular Angle Fracture (Randomized Clinical Trial)

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: V shaped plate 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 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.
Active Comparator: champy technique 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 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.

Arm

Intervention/Treatment

Experimental: V shaped plate

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

Active Comparator: champy technique

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

Outcome Measures

Primary Outcome Measures

proper occlusion [1 week- 3 months and 6 months]
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.

Secondary Outcome Measures

condylar position [6 months]
C.T scan will be taken post operatively after periods of 1week and 6 months to measure condylar position by specialized (software mimics) C.T superimposition.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry , Cairo university	Cairo		Egypt	12311

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Rasha Tohamy Abdelsattar Mohammed, Master's degree candidate, Cairo University

ClinicalTrials.gov Identifier:

NCT06005467

Other Study ID Numbers:

9793

First Posted:

Aug 22, 2023

Last Update Posted:

Aug 22, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Rasha Tohamy Abdelsattar Mohammed, Master's degree candidate, Cairo University

champy

angle fracture

Additional relevant MeSH terms:

Fractures, Bone

Study Results

No Results Posted as of Aug 22, 2023