Displaced Mandibular Angle Fracture Clinical Trial
Official title:
3D Vs Standard Miniplate in Fixation of the MAFs
- The aim of this study is to compare the standard and 3D miniplates fixation in
mandibular angle fractures regarding to wound dehiscence, infection, nonunion, pain,
hypoesthesia, and malocclusion. and to analyze advantages and disadvantages of one
method over the other.
- Radiographic follow-up (in the form of posteroanterior and panoramic radiographs) will
used to evaluate the patients immediately and 2 and 4 months postoperatively. Patients
returned 7 days after surgery for clinical evaluation . The patients will be examined
radiographically for accuracy of the reduction, screw positioning, adverse reactions in
the vicinity of screw placement, and bone healing. the complications encountered will
be recorded and treated. The clinical evaluations will be performed by 1 surgeon at
each institution.
- The patients will also evaluated clinically for infection, nonunion, pain,
hypoesthesia, and malocclusion. Malocclusion will assessed based on patient complaints.
Criteria for infection will based on either of the following conditions: 1) purulent
discharge from an incision and 2) serosanguineous drainage and a wound culture positive
for a known pathogen. All the patients will evaluated postoperatively by a single
assessor.
- Statically analysis :
Student's t test will be used to compare 3D and Champy's miniplate fixation. A value of P ≤
0.05 will be considered statistically significant.
- This study will include 20 dentate patients with mandibular angle fracture whom
presented for treatment at Department Of Oral and Maxillofacial Surgery, Faculty Of
Oral And Dental Medicine, Cairo University.
- The patients after inclusion will be randomly divided into either Group A or Group B.
Group A consist of 10 patients underwent open reduction with internal fixation of the
angle mandibular fracture with 3D titanium miniplates whereas Group B consist of 10
patients underwent open reduction with internal fixation of the mandibular angle
fracture with standard miniplate using a single miniplate technique of Champy's
principle of osteosynthesis.
- Inclusion criteria: 1) Age group between 15-40 years. 2) patients with non-infected and
non-comminuted mandibular angle fractures 3) surgical treatment provided within 7 days
of injury via open reduction and internal fixation (ORIF) by an extra oral approach 4)
no use of postsurgical maxillomandibular fixation (MMF) postoperatively 5) a 1-week
duration of postsurgical oral antibiotic therapy.
- Exclusion criteria : 1) the fracture was infected at the time of treatment, 2) medical
conditions that could possibly have interfered with healing (diabetes, chemotherapy,
etc.) or prevented general anesthesia.
- Preoperative Evaluation
Careful extra and intraoral clinical examinations will be perform on all patients. The
presence of lacerations, swelling, ecchymosis, occlusal disturbances, or broken, avulsed, or
missing teeth will noted, and the mandibular movements, maximal interincisal opening, and
nerve function will be recorded. Palpation of the mandible for areas of tenderness, segment
mobility, bony crepitus, and tooth mobility will be also perform . Radiographic images
(panoramic and posteroanterior) will be taken to evaluate the fracture. Immediately
preoperatively, each patient will be given a standard dose of 1.5 g of Unasyn* and 8 mg of
Epidron** intravenously.
-Surgical Technique:
After placement of arch bars, the fracture line will be exposed through extraoral a
submandibular (Risdon) incision. Only the amount of soft tissue stripping necessary to
visualize, reduce, and stabilize the fracture will be performed. Mobile teeth or teeth with
apices that will be exposed in the fracture will be removed.
All a fracture site will be identified, reduced, and after obtaining satisfactory occlusion,
temporary maxillomandibular fixation will be placed using either Erich's arch bar or Ivy
loop eyelet wiring.
Fixation in group A will be achieved using a 3D curved strut miniplate* (Fig 1) , installed
and stabilized with monocortical screws. The 3D plate will be place in such a way that a
horizontal bar is perpendicular and a vertical bar is parallel to the fracture line. While
in group B fixation will be perform by A single non compression miniplate with 4-hole 2-mm
using 2-mm monocortical screws.
In both group fixation will be carried out through extraoral submandibular approach and
placed in the neutral zone of the mandibular angle (between tension and compression areas).
After fixation of the fracture, intermaxillary fixation will be removed . And the incisions
will be close in layers by absorbable suture while the skin closed by 5-0 nylon sutures. No
drains will placed. and the occlusion will checked .
-Postsurgical Management:
Antibiotics will be continued through the preoperative period and for 5 to 7 days after
surgery. And other medication to control swelling and pain will be administered.
Chlorhexidine mouth rinse will be provided for all patient until removal of arch bars. Soft
diet will be strongly recommend for 2 weeks then Pasty diet will be gradually regained .
-Postoperative Evaluation :
Radiographic follow-up (in the form of posteroanterior and panoramic radiographs) will used
to evaluate the patients immediately and 2 and 4 months postoperatively. Patients returned 7
days after surgery for clinical evaluation . The patients will be examined radiographically
for accuracy of the reduction, screw positioning, adverse reactions in the vicinity of screw
placement, and bone healing. the complications encountered will be recorded by treatment
scoring system and treated. The clinical evaluations will be performed by 1 surgeon at each
institution.
The patients will also evaluated clinically for infection, nonunion, pain, hypoesthesia, and
malocclusion. Malocclusion will assessed based on patient complaints. Criteria for infection
will based on either of the following conditions: 1) purulent discharge from an incision and
2) serosanguineous drainage and a wound culture positive for a known pathogen. All the
patients will evaluated postoperatively by a single assessor.
-Statically analysis :
Student's t test will be used to compare 3D and Champy's miniplate fixation. A value of P ≤
0.05 will be considered statistically significant.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment