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

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ClinicalTrials.gov Identifier: NCT03640039
Recruitment Status : Not yet recruiting
First Posted : August 21, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Khater tarek, Cairo University

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

Condition or disease Intervention/treatment Phase
Mandible Fracture Procedure: 3d strut plate. Not Applicable

Detailed 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  • A Radomized clinical trial.
  • Parallel group study.
  • A trial will be carried out in hospital of oral and maxillofacial surgery department - faculty of dentistry cairo university.
  • Equal randomization: participants with equal probabilities for intervention.
  • Positive controlled: both groups receiving treatment.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study Evaluating Stability of Fracture Segments After Treatment of Mandibular Angle Fracture With 3d Strut Plate in Two Groups One With IMMF and Anthor Without IMMF ;Randomized Clinical Trial.
Estimated Study Start Date : January 11, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: study group: 3d strut plate fixation without post op IMMF.
Open reduction and internal fixation with 3d strut plate without post operative IMMF.
Procedure: 3d strut plate.
Under general anathesia fracture will be exposed and fixed with 3d srut plate.Wound closed in standered fashion. patient will be released from operating room with out IMMF.

Active Comparator: control group: 3d srut plate fixation with post op IMMF.
Open reduction and internal fixation with 3d strut plate with post operative IMMF for 15 days.
Procedure: 3d strut plate.
Under general anathesia fracture will be exposed and fixed with 3d srut plate.Wound closed in standered fashion. patient will be released from operating room with out IMMF.




Primary Outcome Measures :
  1. stability of fracture segments. [ Time Frame: 15 days post operative. ]
    post operative bimanual manipulation of the fracture segment.


Secondary Outcome Measures :
  1. inferior alveolar nerve injury. [ Time Frame: pre operative and 1 week post operative. ]
    measurment by:Neurosensory testing: patient will be asked if there was numbness without stimulus and on stroking the lower lip skin with afinger.The patient will be asked to grade the sensation present on an analog scale from 0 (no sensation) to 10 (completely normal sensation)

  2. Accuracy of fracture reduction. [ Time Frame: one week post operative. ]
    Post operative. Through computed tomography by measuring inter ramus distance using lingula as reference to measure.



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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03640039


Contacts
Contact: Mohamed T khater, MSc +201003854552 m_khater385@yahoo.com

Sponsors and Collaborators
Cairo University
Investigators
Study Director: Hesham A Hakam, Prof Faculty of dentistry, Cairo university

Publications:

Responsible Party: Mohamed Khater tarek, Assistant lecturer., Cairo University
ClinicalTrials.gov Identifier: NCT03640039     History of Changes
Other Study ID Numbers: 2972018
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mohamed Khater tarek, Cairo University:
3d strut plate
mandibular angle fracture

Additional relevant MeSH terms:
Fractures, Bone
Mandibular Fractures
Wounds and Injuries
Jaw Fractures
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Skull Fractures