Comparative Study Evaluating Stability of Fracture Segments After Treatment of Mandibular Angle Fracture With 3d Strut Plate With or Without IMMF.
Primary Purpose
Mandible Fracture
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
3d strut plate.
Sponsored by
About this trial
This is an interventional treatment trial for Mandible Fracture focused on measuring 3d strut plate, mandibular angle fracture
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
study group: 3d strut plate fixation without post op IMMF.
control group: 3d srut plate fixation with post op IMMF.
Arm Description
Open reduction and internal fixation with 3d strut plate without post operative IMMF.
Open reduction and internal fixation with 3d strut plate with post operative IMMF for 15 days.
Outcomes
Primary Outcome Measures
stability of fracture segments.
post operative bimanual manipulation of the fracture segment.
Secondary Outcome Measures
inferior alveolar nerve injury.
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)
Accuracy of fracture reduction.
Post operative. Through computed tomography by measuring inter ramus distance using lingula as reference to measure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03640039
Brief Title
Comparative Study Evaluating Stability of Fracture Segments After Treatment of Mandibular Angle Fracture With 3d Strut Plate With or Without IMMF.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 11, 2019 (Anticipated)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
comparative study evaluating stability of fracture segments in mandibular angle fracture with 3d strut plate with or with out post operative IMMF.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mandible Fracture
Keywords
3d strut plate, mandibular angle fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group: 3d strut plate fixation without post op IMMF.
Arm Type
Experimental
Arm Description
Open reduction and internal fixation with 3d strut plate without post operative IMMF.
Arm Title
control group: 3d srut plate fixation with post op IMMF.
Arm Type
Active Comparator
Arm Description
Open reduction and internal fixation with 3d strut plate with post operative IMMF for 15 days.
Intervention Type
Procedure
Intervention Name(s)
3d strut plate.
Intervention Description
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 Measure Information:
Title
stability of fracture segments.
Description
post operative bimanual manipulation of the fracture segment.
Time Frame
15 days post operative.
Secondary Outcome Measure Information:
Title
inferior alveolar nerve injury.
Description
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)
Time Frame
pre operative and 1 week post operative.
Title
Accuracy of fracture reduction.
Description
Post operative. Through computed tomography by measuring inter ramus distance using lingula as reference to measure.
Time Frame
one week post operative.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed T khater, MSc
Phone
+201003854552
Email
m_khater385@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hesham A Hakam, Prof
Organizational Affiliation
Cairo University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
6503575
Citation
Kellman RM. Repair of mandibular fractures via compression plating and more traditional techniques: a comparison of results. Laryngoscope. 1984 Dec;94(12 Pt 1):1560-7.
Results Reference
background
PubMed Identifier
25232835
Citation
Saman M, Kadakia S, Ducic Y. Postoperative maxillomandibular fixation after open reduction of mandible fractures. JAMA Facial Plast Surg. 2014 Nov-Dec;16(6):410-3. doi: 10.1001/jamafacial.2014.543.
Results Reference
background
PubMed Identifier
15690289
Citation
Guimond C, Johnson JV, Marchena JM. Fixation of mandibular angle fractures with a 2.0-mm 3-dimensional curved angle strut plate. J Oral Maxillofac Surg. 2005 Feb;63(2):209-14. doi: 10.1016/j.joms.2004.03.018.
Results Reference
background
PubMed Identifier
8755408
Citation
Farmand M. [Experiences with the 3-D miniplate osteosynthesis in mandibular fractures]. Fortschr Kiefer Gesichtschir. 1996;41:85-7. German.
Results Reference
background
PubMed Identifier
22809633
Citation
Vineeth K, Lalitha RM, Prasad K, Ranganath K, Shwetha V, Singh J. "A comparative evaluation between single noncompression titanium miniplate and three dimensional titanium miniplate in treatment of mandibular angle fracture"--a randomized prospective study. J Craniomaxillofac Surg. 2013 Mar;41(2):103-9. doi: 10.1016/j.jcms.2012.05.015. Epub 2012 Jul 17.
Results Reference
background
PubMed Identifier
1475603
Citation
Farmand M, Dupoirieux L. [The value of 3-dimensional plates in maxillofacial surgery]. Rev Stomatol Chir Maxillofac. 1992;93(6):353-7. French.
Results Reference
background
PubMed Identifier
24205475
Citation
Sadhwani BS, Anchlia S. Conventional 2.0 mm miniplates versus 3-D plates in mandibular fractures. Ann Maxillofac Surg. 2013 Jul;3(2):154-9. doi: 10.4103/2231-0746.119231.
Results Reference
background
PubMed Identifier
20417012
Citation
Jain MK, Manjunath KS, Bhagwan BK, Shah DK. Comparison of 3-dimensional and standard miniplate fixation in the management of mandibular fractures. J Oral Maxillofac Surg. 2010 Jul;68(7):1568-72. doi: 10.1016/j.joms.2009.07.083. Epub 2010 Apr 22.
Results Reference
background
Learn more about this trial
Comparative Study Evaluating Stability of Fracture Segments After Treatment of Mandibular Angle Fracture With 3d Strut Plate With or Without IMMF.
We'll reach out to this number within 24 hrs