Clinical trial NCT06005467: V Shaped Plate Vs Champy Technique in Mandibular Angle Fractures
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fractures, Bone
Keywords: champy
angle fracture
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: proper occlusion
timeFrame: 1 week- 3 months and 6 months
Secondary outcomes:
measure: condylar position
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry , Cairo university
Study officials:
References:
citation: 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.
citation: 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.