Clinical trial NCT03640039: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Mandible Fracture
Keywords: 3d strut plate
mandibular angle fracture
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 16
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: stability of fracture segments.
timeFrame: 15 days post operative.
Secondary outcomes:
measure: inferior alveolar nerve injury.
timeFrame: pre operative and 1 week post operative.
measure: Accuracy of fracture reduction.
timeFrame: one week post operative.
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Hesham A Hakam, Prof
role: STUDY_DIRECTOR
References:
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.
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.
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.
citation: Farmand M. [Experiences with the 3-D miniplate osteosynthesis in mandibular fractures]. Fortschr Kiefer Gesichtschir. 1996;41:85-7. German.
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.
citation: Farmand M, Dupoirieux L. [The value of 3-dimensional plates in maxillofacial surgery]. Rev Stomatol Chir Maxillofac. 1992;93(6):353-7. French.
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.
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.