- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03608891
Patient Specific Plates Versus Conventional Miniplates for Treatment of Mandibular Body Fractures
Patient Specific Three-Dimensional Titanium Plates Versus Conventional Miniplates for Treatment of Mandibular Body Fractures. (Randomized Clinical Trial)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study will be conducted on two groups:
Intervention group: patient specific three-dimensional titanium plates CBCT or CT scan will be performed for the patient, the dicom files will be imported into a surgical planning software , plates will then be designed virtually and sent for three-dimensional (3D) printing.
Control group: Conventional miniplates:
In this group two miniplates of titanium Mini-System 2.0 mm will be used. The plate has profile height 1.0 mm whereas the screw length varies according to the site of the plate. According to Champy osteosynthesis lines for fixation of the posterior mandibular fracture ,the first plate will be placed at the inferior border from the buccal side, using bicortical screws engaging the buccal and lingual cortices to achieve rigid fixation, while the second plate will be placed at about 5mm superior to the inferior plate in the subapical region, using monocortical screws engaging only the buccal cortex to avoid injuring the teeth roots.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dina A Alei El Dine, Postgraduate
- Phone Number: 01285568850
- Email: dinaadelta3lab@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with unilateral mandibular body fractures, not associated with other mandibular and maxillofacial fractures
Exclusion Criteria:
- Patients with bilateral mandibular fractures
- Patients with other mandibular or maxillofacial fractures
- Comminuted fractures
- Medical problem that may interfere with the procedure such as bleeding disorder and pregnancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control Arm
Conventional titanium miniplates
|
In this group two miniplates of titanium Mini-System 2.0 mm will be used.
The plate has profile height 1.0 mm whereas the screw length varies according to the site of the plate.
According to Champy osteosynthesis lines for fixation of the posterior mandibular fracture ,the first plate will be placed at the inferior border from the buccal side, using bicortical screws engaging the buccal and lingual cortices to achieve rigid fixation, while the second plate will be placed at about 5mm superior to the inferior plate in the subapical region, using monocortical screws engaging only the buccal cortex to avoid injuring the teeth roots.
Other Names:
|
Experimental: Intervention arm
Patient specific 3D plates
|
CBCT or CT scan will be done preoperatively and dicom files will be imported to mimics software to design and print the patient specific 3D titanium plate.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Satisfaction measured with visual analogue scale (0-10)
Time Frame: Measured immediately after the surgery
|
patient satisfaction is defined as patient-reported outcome measure while the structures and processes of care can be measured by patient-reported experiences (30).
Measured on a visual analogue scale (VAS) (29) of 0-10 ,with zero being unsatisfied and 10 being satisfied.
Patient Satisfaction is assessed regarding prescence of pain, occlusal discrepencies and overall patient satisfaction.
|
Measured immediately after the surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fracture gap distance
Time Frame: 0 and 3 months
|
This is done using CBCT through measuring the fracture gap distance in millimeters to evaluate proper reduction and fixation
|
0 and 3 months
|
Occlusal bite force
Time Frame: 0 and 3 months
|
The biting force will be measured through the follow up visits (1 week,3 months) by the bite force recorder at the incisor region, right and left molar region.
The measurement of the bite force will be undertaken using a portable type of occlusal force gauge (GM10, Nagano Keiki, Japan) called OCCLUSAL FORCE-METER GM10.
(36)
|
0 and 3 months
|
Operating time
Time Frame: time of the surgery
|
The time of the surgery will be recorded using a stopwatch.
|
time of the surgery
|
Plate palpability
Time Frame: 0 and 3 months
|
Measured during all follow up visits, by questioning the patient ,where the patient will be informed of the site of the plates ,and asked if he feels the plates are palpable ,and will be measured by binary measuring unit (yes/no) , also the plates will be palpated by the operator at follow up visits.
|
0 and 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed A Farid, PHD, Cairo University
- Study Chair: Mohamed A Abd el Rasol, PhD, Cairo University
Publications and helpful links
General Publications
- Perez R, Oeltjen JC, Thaller SR. A review of mandibular angle fractures. Craniomaxillofac Trauma Reconstr. 2011 Jun;4(2):69-72. doi: 10.1055/s-0031-1272903.
- Goiato MC, Santos MR, Pesqueira AA, Moreno A, dos Santos DM, Haddad MF. Prototyping for surgical and prosthetic treatment. J Craniofac Surg. 2011 May;22(3):914-7. doi: 10.1097/SCS.0b013e31820f7f90.
- Levine JP, Patel A, Saadeh PB, Hirsch DL. Computer-aided design and manufacturing in craniomaxillofacial surgery: the new state of the art. J Craniofac Surg. 2012 Jan;23(1):288-93. doi: 10.1097/SCS.0b013e318241ba92.
- Talwar RM, Chemaly D. Information and computer technology in oral and maxillofacial surgery. Oral Maxillofac Surg Clin North Am. 2008 Feb;20(1):79-89. doi: 10.1016/j.coms.2007.09.006.
- Edwards SP. Computer-assisted craniomaxillofacial surgery. Oral Maxillofac Surg Clin North Am. 2010 Feb;22(1):117-34. doi: 10.1016/j.coms.2009.11.005.
- Hassfeld S, Muhling J. Computer assisted oral and maxillofacial surgery--a review and an assessment of technology. Int J Oral Maxillofac Surg. 2001 Feb;30(1):2-13. doi: 10.1054/ijom.2000.0024.
- Eckardt A, Swennen GR. Virtual planning of composite mandibular reconstruction with free fibula bone graft. J Craniofac Surg. 2005 Nov;16(6):1137-40. doi: 10.1097/01.scs.0000186306.32042.96.
- Bell RB. Computer planning and intraoperative navigation in cranio-maxillofacial surgery. Oral Maxillofac Surg Clin North Am. 2010 Feb;22(1):135-56. doi: 10.1016/j.coms.2009.10.010.
- Al-Abri R, Al-Balushi A. Patient satisfaction survey as a tool towards quality improvement. Oman Med J. 2014 Jan;29(1):3-7. doi: 10.5001/omj.2014.02.
- Butts SC, Floyd E, Lai E, Rosenfeld RM, Doerr T. Reporting of Postoperative Pain Management Protocols in Randomized Clinical Trials of Mandibular Fracture Repair: A Systematic Review. JAMA Facial Plast Surg. 2015 Nov-Dec;17(6):440-8. doi: 10.1001/jamafacial.2015.1011.
- Kumar ST, Saraf S, Devi SP. Evaluation of bite force after open reduction and internal fixation using microplates. J Dent (Tehran). 2013 Sep;10(5):466-77. Epub 2013 Sep 30.
- Rodt T, Bartling SO, Zajaczek JE, Vafa MA, Kapapa T, Majdani O, Krauss JK, Zumkeller M, Matthies H, Becker H, Kaminsky J. Evaluation of surface and volume rendering in 3D-CT of facial fractures. Dentomaxillofac Radiol. 2006 Jul;35(4):227-31. doi: 10.1259/dmfr/22989395.
- Manson PN, Markowitz B, Mirvis S, Dunham M, Yaremchuk M. Toward CT-based facial fracture treatment. Plast Reconstr Surg. 1990 Feb;85(2):202-12; discussion 213-4.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Patient specific plate
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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