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Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03640039
Study type Interventional
Source Cairo University
Contact Mohamed T khater, MSc
Phone +201003854552
Email m_khater385@yahoo.com
Status Not yet recruiting
Phase N/A
Start date January 11, 2019
Completion date June 1, 2020

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