Patient Specific Plates Versus Conventional Miniplates for Treatment of Mandibular Body Fractures

Mandibular Fractures Clinical Trial

Official title:

Patient Specific Three-Dimensional Titanium Plates Versus Conventional Miniplates for Treatment of Mandibular Body Fractures. (Randomized Clinical Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03608891
• Other study ID #: Patient specific plate
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2018
• Est. completion date: July 2019

Study information

• Verified date: July 2018
• Source: Cairo University
• Contact: Dina A Alei El Dine, Postgraduate
• Phone: 01285568850
• Email: dinaadelta3lab[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the current study is to evaluate and assess the clinical stability and efficacy of patient specific computer guided titanium plates versus the conventional titanium mini plates regarding accurate reduction and fixation of mandibular body fractures, reducing the operating time, achieving precise bone alignment and reducing the plate palpability.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Mandibular Fractures

Intervention

Device:
• Computer guided patient specific 3D titanium plate
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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (13)

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. Review. — View Citation

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. Review. — View Citation

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/jamafaci — View Citation

Eckardt A, Swennen GR. Virtual planning of composite mandibular reconstruction with free fibula bone graft. J Craniofac Surg. 2005 Nov;16(6):1137-40. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Hassfeld S, Mühling 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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction measured with visual analogue scale (0-10)	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	Fracture gap distance	This is done using CBCT through measuring the fracture gap distance in millimeters to evaluate proper reduction and fixation	0 and 3 months
Secondary	Occlusal bite force	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
Secondary	Operating time	The time of the surgery will be recorded using a stopwatch.	time of the surgery
Secondary	Plate palpability	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