Ethical Clearance

5/21/2018 Ethical Clearance

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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

monocortical 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-dimensional titanium

miniplates for fracture fixation at the mandibular 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

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Ethical Clearance