RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA, INDIA.

ANNEXURE – II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. / NAME OF THE CANDIDATE AND ADDRESS
(IN BLOCK LETTERS) / Dr. DEGALA NAGAMANI
POST GRADUATE STUDENT,
DEPARTMENT OF ORALAND MAXILLOFACIAL AND RECONSTRUCTIVE SURGERY,
BAPUJIDENTALCOLLEGE AND HOSPITAL, DAVANGERE – 577004,
KARNATAKA.
2. /

NAME OF THE

INSTITUTION

/

BAPUJIDENTALCOLLEGE AND HOSPITAL, DAVANGERE – 577 004.

KARNATAKA.
3. / COURSE OF STUDY AND SUBJECT /

MASTER OF DENTAL SURGERY IN

ORALAND MAXILLOFACIAL SURGERY

4. / DATE OF ADMISSION TO COURSE
5. /
TITLE OF THE TOPIC
/ “RELIABILITY OF SONOGRAPHY IN THE PATIENTS WITH RADIOGRAPHICALLY CONFIRMED DIAGNOSIS OF A MIDFACIAL FRACTURE”
6. / BRIEF RESUME OF THE INTENDED WORK.
6.1: Need for the study :
The complexity of the facial skeleton has led to the development of many specialized views to visualize the entire facial skeleton adequately.Standard facial views, including occipitomental and submentovertex radiographs, are routinely used to diagnose zygomatic bone fractures. Computed Tomography (CT), both coronal and axial cuts, are required in complex cases to assess blow-out fractures and disruption of the orbital walls. The main disadvantages of CT are the patient’s exposure to a high dose of radiation and the potential risk of development of a cataract.Delay in extricating the patient from the machine in an emergency is widely recognized and may prove fatal.1
Magnetic Resonance Imaging (MRI) provides substantially more information about the soft tissue structures but it does not provide enough information about the underlying bone fractures. Both CT and MRI machines are expensive to buy and operate and they are not available in many district general hospitals.1
Sonographic diagnosis may offer an alternative to radiology as a first – line imaging modality. This would lead to decreased radiation exposure of the patient, with conventional radiographs being omitted.2
The aim of this study is to determine the reliability of sonography in the patients with radiographically confirmed diagnosis of a midfacial fracture.

6.2: Review of Literature :

Ultrasound scanning was performed with a real time linear electric scanner employing 5MHz transducer. Clinical examination revealed a depression of zygomatic arch while preoperative Ultrasound scanning revealed the fracture as a high echo line with v-shaped concavity on the affected side. After manipulation it showed high echo line of a continuous zygomatic arch. The use of real time ultrasonograph was done to reposition the anterior maxillary sinus wall and zygomatic arch.3

The usefulness of echography to examine facial bone fractures was evaluated and compared with other diagnostic measures in five patients. A 30MHz and a 15-MHz frequency B-mode ultrasound probe were applied to 5 patients with nasal bone fractures, orbital rim fractures, maxillary fractures and mandibular fractures. Preoperative view of the nasal dorsum showed a clear disruption of the bone and also post-operative view showed satisfactory reduction. In orbital rim fractures, the plain radiograph did not show any fracture line whereas echogram showed fracture of the orbital rim. The maxillary fracture demonstrated a low echoic area adjacent to the fracture line. The mandibular angle fracture was recognized as disrupted line and 6 months postoperatively showed as smooth surface. The ultrasound image of a parasymphysis mandibular fracture showed disrupted line which then was treated.4

22 patients, with suspected fractures of the zygomatico-orbital complex were studied. For all patients routine plain radiographs and ultrasound examination were done. A systematic routine of facial scanning was developed, which included vertical and horizontal, images of the orbit to visualize the orbital floor, medial and lateral walls, infra orbital margin and foramen, as well as the lateral wall of the maxillary sinus. The zygomatic arch and front of zygomatic suture were scanned to detect any discontinuity. The data obtained from the radiographic assessment and the ultrasound investigation were corrected and compared with the operative findings of those patients who were operated on. In 12 of the 22 patients, there was agreement between ultrasound and radiographic findings with regard to the fractures.Ultrasound was accurate in assessing the lateral wall of the maxillary sinus with a sensitivity of 94%, specificity of 100% and positive predictive value. In the assessment of the orbital floor, ultrasound scanning detected 1 false positive and no false negatives, with sensitivity of 100%, specificity of 95%, and positive predictive value of 75%.1

60 patients were evaluated over a period of 10 months prospectively. US investigation was performed with a 7.5MHz curved array transducer and is compared with CT findings. The Ultrasonographicinvestigation of the infraorbital rim showed true-positive results in 31 cases, while in the 23 patients the findings were true – negative. The Ultrasonographic investigation of the orbital floor resulted in 51 true-positive results and in 7 true-negative results. It showed a sensitivity of 95% and specificity of 100% with a diagnostic accuracy of 98%. Positive Predictive Value (PPV) reached 100% and Negative Predictive Value (NPV) reached 77%.5
In a clinical study of 25 patients, ultrasonography was able to detect all fracture and dislocations of the zygomatic arch. It was possible to assess the repositioning in 24 out of 25 cases using ultraosnography.6
6.3. Objective of study :
To determine the reliability of sonography in the diagnosis of midfacial fractures.
7. /

MATRIALS AND METHODS :

7.1. Source of Data :
Patients with midfacial fractures reporting to the Department of Oral, Maxillofacial and Reconstructive Surgery, BapujiDentalCollege and Hospital, Davangere.
7.2. Method of collecting data (including sampling procedure if any)
The study includes 15 patients with clinically and radiographically diagnosed midfacial fractures.The Ultrasound investigation by Phillips Envisor CHD, linear high frequency (3-12 MHz) machine or Aloka prosound SSD-3500SV multi frequency machine.
Criteria for the collection of data will be :
Inclusion criteria :
  • Patients aged 18- 50 yrs with midfacial fractures.
  • Ambulatory patients.
Exclusion criteria :
  • Severe edema following fracture.
The two diagnostic modalities are then compared based on :
  1. Site of fracture.
  2. Degree of assessment of fracture.
  3. Amount of displacement
The results will be analysed by Sensitivity, Specificity, Positive Predictive Value, Negative Predictive value and Fischer’s exact test.
7.3. Does the study require any investigation or intervention to be conducted on patients or other human or animals? If so, please describe briefly.
  • Water’s view
  • Lateral skull
  • Ultrasound
7.4. Has ethical clearance been obtained from your institution in case of 7.3 ?
Yes
Ethical clearance has been obtained and copy of the same is attached.
8. /

LIST OF REFERENCES :

  1. McCann PJ, Brocklebank LM, Ayoub AF. Assessment of zygomatico-orbital complex fractures using ultrasonography. Br J Oral Maxillofac Surg 2000;38:525-29.
  2. Blessmann M, Pohlenz P, Blake FAS, Lenard M, Schmelzle R, Heiland M. Validation of new training tool for ultrasound as a diagnostic modality in suspected midfacial fractures. Int J Oral Maxillofac Surg 2007;36:501-506.
  3. Akizuki H, Yoshida H, Michi K. Ultrasonographic evaluation during reduction of zygomatic arch fractures. J Cranio-Max-Fac Surg 1990;18:263-66.
  4. Hirai T, Manders EK, Nagamoto K, Saggers GC. Ultrasonic observation of facial bone fractures : Report of cases. J Oral Maxillofac Surg 1996;54:776-79.
  5. Jank S, Emshoff R, Etzelsdorfer M, Strobl H, Nicasi A, Norer B. The diagnostic value of ultrasonography in the detection of orbital floor fractures with a curved array transducer. Int J Oral Maxillofac Surg 2004;33:13-18.
  6. Gulicher D, Krimmel M M, Reinert S. The role of intraoperative ultrasonography in zygomatic complex fracture repair. Int J Oral Maxillofac Surg 2006;35:224-30.

9. /

Signature of Candidate

10. /

Remarks of the guide

/ Versatile diagnostic tool helpful in clinical application.
11. /

Name and Designation of

(in block letters)

11.1 Guide
11.2 Signature / Dr. RAJESH KUMAR B.P
PROFESSOR,
DEPARTMENT OF ORAL, MAXILLOFACIAL AND RECONSTRUCTIVE SURGERY,
BAPUJIDENTALCOLLEGE AND HOSPITAL,
DAVANGERE-577 004.

11.3 Co-Guide (if any)

11.4 Signature

11.5 Head of Department

11.6 Signature / Dr. KIRTHI KUMAR RAI
PROFESSOR AND HEAD,
DEPARTMENT OF ORAL, MAXILLOFACIAL AND RECONSTRUCTIVE SURGERY,
BAPUJIDENTALCOLLEGE AND HOSPITAL,
DAVANGERE-577 004.
12. /

12.1 Remarks of the Chairman and Principal.

12.2 Signature

RECOMMENDATIONS OF THE ETHICAL COMMITTEE

The committee has looked into the proposed study topic of Dr. Degala Nagamani. “Reliability of sonography in the patients with radiographically confirmed diagnosis of a midfacial fracture”. – Postgraduate, Department of Oral and Maxillofacial Surgery, in its complete perspective and is of the conscientious opinion that the study can be conducted with out any legal, moral or ethical encumbrances.

The inclusion and exclusion criteria, method of selection of patients, ramifications, expected complications, review of literature have been critically analyzed and consent given for proceeding further with the study. However, it has been made mandatory to procure a written informed consent from patients who volunteer to be included in the study making it necessary to conduct the study under the strict supervision and guidance of the Head of the Department.

Any complications arising shall be referred to and managed by the staff physician who is also a member of the expert panel. The scientific study is on the current norms for research work in clinical studies.

Dr. K. Sadashiva Shetty

Chairman

Ethical Committee

RECOMMENDATIONS OF THE ETHICAL COMMITTEE

The committee has looked into the proposed study topic of Dr. Suma A. “Microbiological study and antimicrobial sensitivities in isolates from head and neck space infections”. – Postgraduate, Department of Oral and Maxillofacial Surgery, in its complete perspective and is of the conscientious opinion that the study can be conducted with out any legal, moral or ethical encumbrances.

The inclusion and exclusion criteria, method of selection of patients, ramifications, expected complications, review of literature have been critically analyzed and consent given for proceeding further with the study. However, it has been made mandatory to procure a written informed consent from patients who volunteer to be included in the study making it necessary to conduct the study under the strict supervision and guidance of the Head of the Department.

Any complications arising shall be referred to and managed by the staff physician who is also a member of the expert panel. The scientific study is on the current norms for research work in clinical studies.

Dr. K. Sadashiva Shetty

Chairman

Ethical Committee

RECOMMENDATIONS OF THE ETHICAL COMMITTEE

The committee has looked into the proposed study topic of Dr. Vikas Aneja. “Evaluation of condylar changes following orthognathic surgery, a retrospective study”. – Postgraduate, Department of Oral and Maxillofacial Surgery, in its complete perspective and is of the conscientious opinion that the study can be conducted with out any legal, moral or ethical encumbrances.

The inclusion and exclusion criteria, method of selection of patients, ramifications, expected complications, review of literature have been critically analyzed and consent given for proceeding further with the study. However, it has been made mandatory to procure a written informed consent from patients who volunteer to be included in the study making it necessary to conduct the study under the strict supervision and guidance of the Head of the Department.

Any complications arising shall be referred to and managed by the staff physician who is also a member of the expert panel. The scientific study is on the current norms for research work in clinical studies.

Dr. K. Sadashiva Shetty

Chairman

Ethical Committee

RECOMMENDATIONS OF THE ETHICAL COMMITTEE

The committee has looked into the proposed study topic of Dr. Ravi Kant Singh. “Maxillomandibular fixation – Transmucosal screws V/s Arch bars”. – Postgraduate, Department of Oral and Maxillofacial Surgery, in its complete perspective and is of the conscientious opinion that the study can be conducted with out any legal, moral or ethical encumbrances.

The inclusion and exclusion criteria, method of selection of patients, ramifications, expected complications, review of literature have been critically analyzed and consent given for proceeding further with the study. However, it has been made mandatory to procure a written informed consent from patients who volunteer to be included in the study making it necessary to conduct the study under the strict supervision and guidance of the Head of the Department.

Any complications arising shall be referred to and managed by the staff physician who is also a member of the expert panel. The scientific study is on the current norms for research work in clinical studies.

Dr. K. Sadashiva Shetty

Chairman

Ethical Committee

6.11.2007

Davangere.

From

Dr. DEGALA NAGAMANI

I Year Post Graduate Student,

Department of Oral, Maxillofacial and Reconstructive Surgery,

BapujiDentalCollege and Hospital,

Davangere.

To

The Chairman

Ethical committee,

BapujiDentalCollege and Hospital,

Davangere.

Through

The Head of the Department

Department of Oral, Maxillofacial and Reconstructive Surgery,

BapujiDentalCollege and Hospital,

Davangere.

Respected Sir,

Subject : Application for ethical clearance certificate for main dissertation.

I, Dr. Degala Nagamani, Post Graduate Student, doing my dissertation titled“RELIABILITY OF SONOGRAPHY IN THE PATIENTS WITH RADIOGRAPHICALLY CONFIRMED DIAGNOSIS OF A MIDFACIAL FRACTURE” needradiographs and ultrasound, for which I need ethical clearance certificate. Kindly do the needful and oblige.

Thanking you.

Dr. Kirthi Kumar Rai

Professor and Head,

Department of Oral, Maxillofacial and Reconstructive Surgery,

BapujiDentalCollege and Hospital,

Davangere.

Yours sincerely

[Dr. Degala Nagamani]