V Shaped Plate Vs Champy Technique in Mandibular Angle Fractures

NCT ID: NCT06005467

Last Updated: 2023-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-31

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fractures, Bone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Comminuted angle fractures.
2. Infected angle fracture.
3. Bilateral angle fracture.
4. Patients with any systemic diseases that affect bone healing.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Rasha Tohamy Abdelsattar Mohammed

Master's degree candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry , Cairo university

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Rasha Tohamy, BSc.

Role: CONTACT

01066534079 ext. +2

Alaa Hassan, BSc.

Role: CONTACT

01090101125 ext. +2

References

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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.

Reference Type BACKGROUND
PMID: 36896057 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28913310 (View on PubMed)

Other Identifiers

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9793

Identifier Type: -

Identifier Source: org_study_id

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