ethical clearance
DESCRIPTION
thesisTRANSCRIPT
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The human face constitutes the first contact point in several
human interactions, thus injuries and/or mutilation of the facial
structures may have a disastrous influence on the affectedperson
The facial area is one of the most frequently injured parts of thebody , and the mandible is one of the most commonly fractured
maxillofacial bones
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The mandibular fracture account for 36% to 54% of all fractures
in the maxillofacial region, followed by the maxilla (46%), thezygoma (27%), and the nasal bones (19.5%).
Internal fixation of mandibular fractures using plates and
screws is now an established method of treatment.
Two fundamentally different phil- osophies have evolved.
Spiessl and the AO/ASIF group (Arbeitsgemeinschaft fiir
Osteosynthesefragen/ Association for the Study of Internal
Fixation) introduced the use of rigid plates with 2.7 mmbicortical screws in 1972
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A method of stable fixation with mini-plates and 2 mm
mono- cortical screws was advocated by Michelet in 1973for the midface and was applied to the mandible by
Champy in 1975
In this study we wish to compare between standard miniplateand 3D titanium plate for open reduction and intermaxillary
fixation in displaced/undisplaced fractures in symphysis and
parasymphysis region of mandible
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MATERIALS AND METHODS
SOURCE OF DATA
This study will be carried out as a prospective randomized
clinical trial evaluating the prognosis of the incision site and
fracture healing and associated complications if any , following
the treatment of symphysis and parasymphysis fractures withopen reduction and stable internal fixation.
The patients for this study will be selected from those visiting
the Department Of Oral And Maxillofacial Surgery, RegionalDental College,Guwahati during the period of 1st april 2013 to
30th November 2014. All subjects will be taken informed
consent
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Selection criteria
The patients will be selected based on certain criteria:-
Inclusion criteria
1. Immunocompetent patients - male and female between the
age 25-55yrs.
2. Patients with mandibular fractures involving symphysis or
parasymphysis fractures.
3. Patients available for regular periodic review.
4. Fractures with or without displacement requiring open
reduction.
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Exclusion criteria
The patients will be excluded for the study if they presented
with any of the following:
1. Communited fractures
2. Infection of the fracture site on initial presentation.
3. Fracture resulting from gun shot wounds.
4. Immunocompromised medical status.
5. Patients allergic to penicillin.
6. Patients with bone loss,intraoral or extraoral wounds
incapable of immediate and complete closoure following
reduction of the fracture or those with pathological
abnormalities of the bone will not be selected.
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STUDY DESIGN
All the patients will be treated with semi rigid fixation i.e.
miniplates with 2mm monocortical screws & 3D titanium
plates via intraoral approach. The patients will be selected
randomly and grouped into two.
GROUP A- Patients-These will receive standard treatment
(ORIF with 2mm titanium miniplate and screws)via intraoralapproach ..
GROUP B- Patients- These will receive standard treatment
(ORIF with 3D titanium miniplate and screws)via intraoralapproach
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PARAMETERES TO BE ASSESSED IN THIS STUDY.
The treated patients will be prospectively followed and
examined for the post operative complications such as:
Pain.
Swelling
Infection.Dehiscence.
Sensory Disturbances.
Non union/Mal union of the fracture site.
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SURGICAL PROTOCOL
The patients with uncomplicated mandibular symphysis or parasymphysis
fractures undergoing open reduction and internal fixation will be
prepared according to the standard protocol and then shifted to the
major or minor O.T based on the type of anesthesia given (G.A/L.A)
SURGICAL TECHNIQUE
The surgical sites will be scrubbed with Savlon (Chlorhexidine Gluconate
1.5% + Cetrimide 3%) then painted with betadine (povidone iodine 5%)
and draped in the usual standard procedure.
The surgical approach to the fracture reduction in all the cases of thestudy will be through intra-oral access.
Disinfection of the oral cavity with saline and betadine (Povidine Iodine
5%) will be done.
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The mucoperiosteal flap will be raised carefully ,keeping the
mental neurovascular bundle intact.
The fracture site shall then be exposed by subperiostealdissection, the fracture fragments subsequently reduced and
fixed with titanium plates and screws.
The surgical site will be irrigated with copious saline and
betadine followed by a double layer closure with 3-0 mersilk and
3-0 vicryl.The muscle and the mucosal layers,shall be , closed on
a same level
A pressure dressing, such as elastic tape, shall be used to preventhematoma and to maintain the position of the repositioned
facial muscles and shall be removed after 24 hrs.
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History of-
a-Unconsciousness
b-Vomitingc-Bleeding from Ear /Mouth/Nose.
d-Amnesiae-Epistaxis
Number of days lapsed after trauma-
Medical history-
a-Cardiovascular system
B-Respiratory system
c-Central nervous system
d-OTHERS
Personal history
Family history
CLINICAL EXAMINATION
-GENERAL PHYSICAL EXAMINATION
Anemia : YES/NO
Jaundice : YES/NO
Cyanosis :YES/NO
Clubbing :YES/NO
Edema :YES/NO
Lymphadenopathy :YES/NO
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VITAL SIGNS:
Pulse Temperature
B.P. Respiratory rate
-LOCAL EXAMINATIONEXTRAORAL
A-INSPECTION
-Hemorrhage
-Lacerartion
-Tissue loss
-Abrasion
-Ecchymosis
-Edema- None / Mild / Moderate / Severe
-Contour defect
B-PALPATION
-Tenderness
-Step deformity
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C t
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Consent
form
POST OPERATIVE EVALUATION OF THE PATEINT
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POST -OPERATIVE EVALUATION OF THE PATEINT
INFERENCES
SECOND POST-OPERATIVE DAY:
Clinical evaluationMeasurement of swelling: None / Mild / Moderate / Severe
Measurement of pain: None / Mild / Moderate / Severe
Sensory disturbances( if any)-Y/N
Status of wound:Infection-Y/N
Dehiscence-Y/N
SEVENTH POST-OPERATIVE DAY
SECOND POST OPERATIVE WEEK
SIXTH POST OPERATIVE WEEK
Radiographical evaluation
Non-union/malunion-Y/N
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. DOES THE STUDY REQUIRE ANYINVESTIGATION OR INTERVENTIONS TO BECONDUCTED ON PATIENTS OR OTHERHUMAN OR ANIMALS? IF SO, PLEASEDESCRIBE BRIEFLY.
Yes.
Patient would have to undergo CT scan twice
one immediate postoperatively and sixth weekpostoperatively.
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The bone density will be assessed in Hounsfield units
using Phillips Kodak Dicom viewer software by feeding
the immediate post op CT and 6thweek post op CT scan
and analysing the area of interest.
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HAS ETHICAL CLEARANCE BEEN
OBTAINED FROM YOUR INSTITUTION IN
CASE of the proposed thesis?
Applied For
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References1. Booth PW, Schendel SA, Hausamen J-E: Maxillofacial Surgery, Vol 1 (ed 2).
London, UK, Churchill Livingstone, 2007, pp 74-76
2. Gear AJ, Apasova E, Schmitz JP, et al: Treatment modalities for mandibular
angle fractures. J Oral Maxillofac Surg 63:655, 2005
3. Zix J, Lieger O, Iizuka T: Use of straight and curved 3-dimen- sional titanium
miniplates for fracture fixation at the mandib- ular angle. J Oral Maxillofac
Surg 65:1758, 2007
4. Lambotte A: Chirurgie Operatoire des Fractures. Paris, France, Masson,
1913
5. Farmand M, Dupoirieux L: The value of 3-dimensional plates inmaxillofacial surgery. Maxillofac Surg 93:353, 1992
6. Farmand M: The 3-dimensional plate fixation of fractures and osteotomies.
Facial Plast Surg 3:39, 1995 7. Farmand M: The 3-D plating system in
maxillofacial surgery. J Oral Maxillofac Surg 51:166, 1993