Radiographic and Clinical Evaluation of Three-Dimensional Delta Plate in Internal Fixation of Mandibular Sub-condylar Fractures.
Phase: NA
Conditions: Mandible Fracture
Sponsor: Ain Shams University

 
 
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                                                                                                                            Research Code  
 
 
Radiographic and Clinical Evaluation of Three-Dimensional 
Delta Plate in Internal Fixation of Mandibular Sub-condylar 
Fractures. 
(Longitudinal Study) 
 
Research Protocol   
Submitted to the Department of Oral and Maxillofacial Surgery  
 Faculty of Dentistry, Ain Shams University.  
  
In partial fulfillment of the requirements of Masters’ degree in Oral 
and   Maxillofacial Surgery. 
  
 By:  
  
Maha Mohamed Naguib Mohamed Hassan EL-Mahdy 
  
 B.D.S. Faculty of Dentistry Ain Shams University  
2019 
Email: mahamohamednageb07@gmail.com 
 
 
 
 
 

 
 
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Under the Supervision of:  
  
  
  
Prof. Dr.Heba Abdul Wahed Sleem 
 
Professor of Oral and Maxillofacial Surgery 
Faculty of Dentistry 
Ain Shams University 
 
 
 
Dr. Ramy Mohamed Gaber 
 
Lecturer of Oral and Maxillofacial Surgery 
Faculty of Dentistry 
Ain Shams University 
 
 
Dr. Mohamed Hamdy Mohamed Ashor  
Fellow of Oral and Maxillofacial Surgery  
Ahmed Maher Teaching Hospital 
 
 
 
Year of protocol registration 
2023 
 
 
 
 

 
 
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Table of Contents 
Topic  
Page  
I. Abstract   
4 
II. Background  
5  
III. Research Question  
8  
IV. Aims (Objectives)  
 9 
V. Hypothesis  
 10 
VI. Ethical Considerations   
11  
VII. Study design   
 13 
VIII. Materials and Methods  
• 
Study setting   
• 
Sample Size  
• 
Study Procedures 
 14 
15 
16 
17 
IX. Statistical Analysis  
 18 
X. Funding of the Study  
 19 
XI. References  
 20 
XII. Arabic summary   
23 
 

 
 
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I.Abstract:   
 
Management of Sub-condylar fractures has been debatable for years, some 
surgeons advocate closed management if the situation permits, to avoid the 
complications associated with open reduction and internal fixation (ORIF). 
Nowadays, there are meticulous approaches and novel osteosynthesis systems that 
facilitate its open management but many of these systems need more research work 
to evaluate its efficacy. 
 
 In this study we intend to examine the efficacy of 3D delta plates from the 
radiographic and clinical point of view. This Single arm study will include 14 cases 
of trauma having mandibular sub condylar fractures, in which open reduction and 
internal fixation are indicated. After selecting patients according to the inclusion 
criteria, all patients will undergo open reduction and rigid fixation. Fracture will be 
stabilized using 4 hole, 2.0 mm 3-D Delta titanium plates using pre-auricular or 
retromandibular incision. 
 
     Postoperative clinical examination will be carried out on day three, day seven, 
one month and after three months. Postoperative radiographic examination will be 
performed immediately postoperative by CT scan. 
 

 
 
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II. Background: 
 
   The incidence of mandibular condylar fractures is estimated to be 17.5–52% 
making it the most seen mandibular fracture (1–4)   Sub condylar fractures are 
commonly encountered when the fracture is unilateral. However, in case of bilateral 
fracture pattern, the condylar heads are the ones that are fractured (5). 
 
 
   The reason for the high incidence of mandibular condyle fracture is attributable to 
the binding of the mandibular ramus with high stiffness and mandibular condyle 
head with low stiffness ((6) causative factors include physical trauma, road traffic 
accidents, violence, fall, sports, and gunshot wound. Internal causative factors 
include osteomyelitis, benign or malignant tumor, and muscular spasm during 
electric shock treatment (7). 
 
 
   The management of condylar fractures is highly controversial and includes   
observation, closed treatment, and open reduction. It depends on multiple  
 factors such as the age of the patient, the co-existence of other mandibular 
 or facial fractures, is it unilateral or bilateral, the level and displacement of the 
fracture, the stage of dentition and dental occlusion, the facilities in the area, 
patient’s mental and physical conditions ((8). 
 
 
 
 

 
 
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    Closed management of condylar fractures has lots of long-term complications    
like pain which is considered the most common complaint. In addition to     esthetic 
problems like facial asymmetry due to shortening of ramus especially   with 
unilateral fractures ((9).  Moreover, Temporomandibular diseases such as ankylosis, 
internal derangement of the temporomandibular joint (TMJ) and    mouth deviation 
could happen. Nevertheless, Closed management is essential in some cases   like 
simple patterns of fractures when occlusion is achievable, putting into consideration 
that patient’s compliance, mental and physical status are crucial for successful 
treatment (8). Its main benefit (when indicated) is the avoidance of facial nerve 
injury, However, facial nerve injury risk is decreased as the operator’s experience 
and skill increase(10) . 
 
     Indications for ORIF include bilateral fractures(relative), severe dislocation (> 10 
degrees), other facial fractures affecting the occlusion, foreign bodies, lateral 
displacement of the condyle, and condyle displacement into the middle cranial 
fossa(11), mandibular nerve paraesthesia(12). Condylar fractures can be reached 
through trans -facial or intraoral approaches (13,14) .Singh et al (15) published the 
largest blinded, randomized controlled trial comparing open techniques with closed 
management; they concluded that both treatment options carry promising outcomes. 
However, the surgically treated group showed better results in all objective and 
subjective functional outcomes except for occlusion. 
 
   The gold standard osteosynthesis system is the use of two miniplates fixation 
secured with four screws each (16). However, some drawbacks such as; difficult 
accessibility that elongates operation time especially in higher fractures the use of 
double miniplates is associated with risk of facial nerve injury and subsequent facial 
nerve palsy. Moreover, the little amount of bone that is always encountered at the 
proximal part of the fracture (17). 
 
 

 
 
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    Recently, Osteosynthesis devices with various shapes and sizes as single L, Y 
plate, or 3-D plate are used for the management of condylar fractures. Manufactures 
tend to develop such systems to gain outcomes similar to that of the conventional 2 
mini-plate system regarding functional stability and rigidity with less cost, less 
complications and less effort(17). 
 
 
   Several studies were conducted on three-dimensional plating systems such as 
Rhomboid, Trapezoid and Delta shaped plates that yielded good outcomes (17–21). 
One study claimed that trapezoidal condylar plate is convenient for low sub condylar 
fractures because of its wide dimensions, On the other hand, delta plate is suitable 
for both high and low sub condylar fracture. ((22–24) 
 
 
   
    The aim of this study is to evaluate the versatility of three-dimensional delta plate 
in reduction and fixation of this type of fracture in adult patients presented with 
unilateral sub-condylar fractures for primary ORIF. The results will be analyzed by 
radiographic assessment of proper anatomical reduction and measurement of vertical 
ramus height. In addition to, clinical outcomes of pain with jaw movements and 
measurement of all mandibular movements range. 
  
 
 
 
 
 
 
 
 
 

 
 
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III.  Research Question:   
What are the radiographic and clinical outcomes of using three-dimensional Delta 
plate for primary open reduction and internal fixation of unilateral subcondylar 
fractures in adult patients? 
  
PICOTS Elements:  
Patient/Problem  
 Adult patients presenting with unilateral 
sub condylar fracture, with or without 
concomitant facial or mandibular fractures. 
Intervention  
 Primary ORIF using three-dimensional 
delta plate 
Comparator  
 - 
Outcome   
 Pain, posterior facial height, anatomic 
reduction, mouth deviation. 
Time   
 3 months follow up 
Setting  
 Faculty of Dentistry-Ain Shams University  
 
 
 
 
 
 
 
 
 

 
 
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IV. Aim of the Study, Research Objectives and Clinical 
Relevance Aim:  
   The aim of the study is to assess the efficacy of the delta plate in fixation of sub 
condylar fractures by radiographic evaluation of anatomic reduction and vertical 
ramus height and clinical evaluation of pain with jaw movements and range of 
mandibular movements. 
  
Outcomes:  
Primary outcomes: 1-Anatomic Reduction  
                               2-Posterior Facial Height 
  
 
Secondary outcomes: 1-Pain  
                                   2-Mandibular Movements. 
                      
                                                   
 
 
 
Clinical Relevance:     
Delta plate provides functionally stable osteosynthesis. In addition to, less periosteal 
dissection, and easier reduction and fixation of small fragments combined with the 
advantages of a smaller plate size, less cost and adequate stiffness (19,23). 
 
 
 
 
 
 
 
 
 

 
 
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V. Hypothesis:  
Delta plate doesn’t provide an added advantage over the other Osteosynthesis 
methods of Sub condylar fixation. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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VI. Ethical consideration  
Open reduction and internal fixation of sub condylar fractures is accompanied with 
complications such as facial nerve injury, parotid gland fistula, permanent scar, 
infection, pain, edema, and difficulty in mastication following surgical procedure.  
  
Risk of Facial injury can be decreased by choosing the appropriate incision and 
meticulous dissection of the tissues. 
 
Parotid gland fistula is avoided by suturing of parotid capsule or by retroparotid-
retromandibular approach whenever possible. 
 
Permanent scar is best minimized by minimal tissue trauma, suturing in layers then 
the skin will be sutured by Prolene 6-0, Topical antibiotics and topical silicone gel 
will be prescribed. 
  
Risk of Infection is reduced by post-operative antibiotic.  
  
Post-operative analgesics and anti-inflammatory medications will be given to 
control pain and edema.  
 
Mastication force is enhanced by physiotherapy. 
 
Patients are allowed to withdraw from the trial whenever they want to. In this case, 
they will be surgically managed by conventional plating systems. All patients will 
be fully informed about the procedures. The risks and benefits will be thoroughly 
explained to them. No surgery will be performed without written consent.  
 
All personal information and data of the patients will be preserved, maintained and 
stored in a special filing system available in the department. It will not be exposed 
to anyone that is not included in the surgical team.  
  

 
 
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The research ethics committee, Faculty of Dentistry Ain Shams University, will 
review the research plan. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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VII. Study Design: 
     Longitudinal study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
VIII. Materials and Methods:  

 
 
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14 patients having unilateral sub condylar fractures will undergo open reduction and 
internal fixation by a single 4-hole miniplate 3D Delta plate. The dimensions of this 
plate are 1.0 mm thick, 20mm long, 5mm wide at top and 14 mm wide at the base. 
At the top of the plate is an arm with two longitudinally arranged holes, two more 
holes form the 2 corners of the base of the plate. 
 
 
Study Setting:  
Department of oral and maxillofacial surgery in the Faculty of Dentistry, Ain 
Shams University. 
Sample Size Calculation:  
The sample size was estimated based on research published by Manoj et al. study 
(2015) regarding fracture fixation by trapezoidal 3D plate in India, by fixing alpha 
at 0.05 (5%) and beta at 0.05(5%), the minimal sample size is 10 patients to be 
included. To avoid drop out the sample was increased to 14 patients(25). 
 
Eligibility criteria 
Inclusion Criteria:  
1-Patients at or over 18 years. 
2-Unilateral sub condylar fractures. 
Exclusion Criteria:  
1- Bilateral sub condylar fractures 
2-Pediatric patients. 
3-Intracapsular fractures  
4-Patients with Uncontrolled systematic conditions. 
 
 

 
 
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Justification for Exclusions: 
-Most clinical and radiographic assessments of bilateral sub condylar fractures are 
dissimilar to that of unilateral ones. 
-The management of pediatric patients is totally different from that of adults. 
-Intracapsular fractures is best treated by endoscopic approach or conservatively 
managed  
-Patients with Uncontrolled systematic conditions are unfit for surgery. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pre-operative Assessment: 

 
 
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  All patients will undergo radiographic assessment with Computed Tomography to 
assess the level of the fracture, degree and direction of displacement and shortening 
of ramus height by comparing the two sides. 
 
  All patients will undergo clinical evaluation of pain, mandible deviation on opening 
and closing, measurement of mandibular movements. 
 All patients will undergo pre-operative anesthetic evaluation which includes 
medical and surgical history, physical examination, investigations, risk assessment, 
consent and pre-medication. 
  
 Surgical Procedure: 
   All patients will undergo open reduction and internal fixation under general 
anesthesia. 
  The Fracture will be exposed either extraorally (submandibular or retromandibular 
or endaural approaches). The incision will be chosen according to the level of the 
fracture. 
  Fracture will be reduced; occlusion will be re checked then it will be fixated by 2.0 
mm 3D Delta mini plates and anchored by 4 screws of 7-9 mm length. 
 
Immediate post-operative medications:  
All patients will take painkillers, anti-inflammatory, antibiotics and steroids. 
 
 
 
 
 
 
Follow up: 

 
 
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Radiographic outcomes: The following will be measured on CT: 
1-The vertical ramus height will be done by comparing the two sides from the 
glenoid fossa to the inferior border of the ramus on CT. 
2- Accuracy of anatomical reduction detected on coronal and axial sections. 
 
Radiograph will be taken immediately post-operative. 
 
Clinical outcomes:  
1- Assessment of pain by Visual Analogue scale. 
2- Mandibular movements by a ruler: 
   -Lateral mandibular movement by measuring the horizontal distance between 
upper central teeth midline to the lower central teeth midline. 
  -Protrusive mandibular movement by measuring the transvere distance between 
upper central teeth midline to the lower central teeth midline. 
-Maximal mouth opening by measuring the vertical distance between upper central 
teeth midline to the lower central teeth midline. 
   
 Follow up notes will be taken on day three, day seven, one month  and Three months 
postoperatively. 
 
. 
 
  
 
 
 
 
 
 

 
 
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IX. Statistical Analysis: 
Regarding the continuous date, the T dependent test will be used to assess the 
statistical data. Regarding the discrete data, Chi Square test will be used to assess 
the statistical data significance, using SPSS Software. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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X. Funding of the Study: 
  
The research study will be self-funded by the operator. No internal or external 
funding will be shared in this study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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XI. References:  
 
 
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