Comparative Study Evaluating Stability of Fracture Segments After Treatment of Mandibular Angle Fracture With 3d Strut Plate With or Without IMMF.

Cairo University (CU)

Status: Unknown

Conditions: Mandible Fracture

Treatments: Procedure: 3d strut plate.

Study type: Interventional

Funder types: Other

Identifiers

NCT03640039

2972018

Details and patient eligibility

About

comparative study evaluating stability of fracture segments in mandibular angle fracture with 3d strut plate with or with out post operative IMMF.

Full description

Two group of patient with mandibular angle fracture indicated for open reduction and internal fixation ,first group will be fixed with 3d stut plate with post operative IMMF. Second group will be fixed with 3d strut plate with out post operative IMMF.

Eligble patients will be randomised in equal proportions between study group (3d strut plate with out post operative IMMF) and control group (3d strut plate with post operative IMMF).

A- 3D strut plate without post operative IMMF:

• Pre operative computed tomography will be done for patient.
• Intra operative :all cases will under go general anathesia.
• Exposure of the fracture segments using vestubular incision.
• Inter-maxillary fixation will be done.
• The fracture segment will be reduced in normal anatomic postion guided with occlusion.
• The fracture segment will be fixed in postion using 3d srut plate.
• Closure of surgical incision.
• Post operative computed tomograghy will be done for the patient.
• Patient will be dismissed from operation room without IMMF.

B- 3D strut with post operative IMMF:

• Pre operative computed tomography will be done for patient.
• Intra operative :all cases will under go general anathesia.
• Exposure of the fracture segments using vestubular incision.
• Inter-maxillary fixation will be done.
• The fracture segment will be reduced in normal anatomic postion guided with occlusion.
• The fracture segment will be fixed in postion using 3d srut plate.
• Closure of surgical incision.
• Post operative computed tomograghy will be done for the patient.
• Patient will be dismissed from operation room with IMMF for 15 days.

Follow up for both groups :

Clinical examination will be done at first week post operative and patients will be examined every week for one month. Last follow up visit will be after three months post operative.

Enrollment: 16 estimated patients

Sex: All

Ages: 15 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with mandibular angle fracture with or witout other fracture indicated for Open reduction internal fixation in the mandible.
• Patient over 15 years old age and both sexes were included in this study.
• Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
• Patients with good general condition allowing major surgical procedure under general anesthesia.
• Patients with physical and psychological tolerance.

Exclusion criteria

• Patients with comminuted fractures as it is not indicated for compression osteosynthesis like3d strut plate .
• Patients with high risk systemic diseases like uncontrolled diabetes mellitus. As uncontrolled diabetes mellitus has a negative impact on normal bone healing.
• Patients with old and/or mal-union fractures. As they will affect accuracy of reduction of the fractured segments.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

study group: 3d strut plate fixation without post op IMMF.

Experimental group

Description:

Open reduction and internal fixation with 3d strut plate without post operative IMMF.

Treatment:

Procedure: 3d strut plate.

control group: 3d srut plate fixation with post op IMMF.

Active Comparator group

Description:

Open reduction and internal fixation with 3d strut plate with post operative IMMF for 15 days.

Treatment:

Procedure: 3d strut plate.