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

Mandible Fracture Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03640039
• Other study ID #: 2972018
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 11, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: August 2018
• Source: Cairo University
• Contact: Mohamed T khater, MSc
• Phone: +201003854552
• Email: m_khater385[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: June 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Mandible Fracture
• Mandibular Fractures

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (8)

Farmand M, Dupoirieux L. [The value of 3-dimensional plates in maxillofacial surgery]. Rev Stomatol Chir Maxillofac. 1992;93(6):353-7. French. — View Citation

Farmand M. [Experiences with the 3-D miniplate osteosynthesis in mandibular fractures]. Fortschr Kiefer Gesichtschir. 1996;41:85-7. German. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stability of fracture segments.	post operative bimanual manipulation of the fracture segment.	15 days post operative.
Secondary	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)	pre operative and 1 week post operative.
Secondary	Accuracy of fracture reduction.	Post operative. Through computed tomography by measuring inter ramus distance using lingula as reference to measure.	one week post operative.