RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

1. / NAME OF THE CANDIDATE AND ADDRESS / Dr. VIKAS ANEJA
POST GRADUATE STUDENT,
DEPARTMENT OF ORAL AND MAXILLOFACIAL AND RECONSTRUCTIVE SURGERY,
BAPUJI DENTAL COLLEGE AND HOSPITAL DAVANGERE-577004
KARNATAKA
2. / NAME OF THE INSTITUTION / BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANGERE-577004
3. / COURSE OF STUDY AND SUBJECT / MASTER OF DENTAL SURGERY IN ORAL AND MAXILLOFACIAL SURGERY
4. / DATE OF ADMISSION TO THE COURSE
5. / TITLE OF THE TOPIC / “EVALUATION OF CONDYLAR CHANGES IN PATIENTS FOLLOWING ORTHOGNATHIC SURGERY, A RETROSPECTIVE STUDY’’.

KARNATAKA BANGALORE

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

6. /
BRIEF RESUME OF THE INTENDED WORK:
6.1: NEED FOR THE STUDY:
The occurrence of condylar resorption is an unpleasant feature that seems to make the outcome of orthognathic surgery less predictable. There is often a dilemma as to what to do, when the occlusion is not stable or the esthetic results are not acceptable. Repeated surgery suggested in many cases but there are no long term results available with conservative treatment.
This study is to evaluate the condylar changes along with the form and function following orthognathic surgery as well as to asses what factors may have contributed to the problems, so that these contributing factors can be predetermined and one can also determine the treatment outcome to prevent long term deformity.
6.2: REVIEW OF LITERATURE :
Condylar changes are observed in radiographs following surgical treatment for dentofacial deformities. The risk of resorption increases because of increased condylar loading, disc replacement and eventual immobilization. The radiographic assessment was done by using standardized cephalograms. The intention was to examine the quantitative changes at the condyle in the high angle mandible deficiency group treated with bimaxillary surgical procedure. Author found no co-relation between amount of resorption and magnitude of mandibular advancement, and no definitive co-relation between age and resorption. Various studies have shown that degenerative arthritis occurs in women mostly1.
In this study the contributing factors which causes skeletal relapse following orthognathic surgery, are discussed. In radiographic analysis the author observed that condylar resorption is the main contributing factor causing skeletal relapse and development of post-operative occlusal and skeletal changes. It was noted that the condylar resorption was most apparent in mandibular advancement procedure that rotate mandibular in counterclockwise direction. Some case reports are mentioned which illustrate the importance of evaluating pre-operative and post-operative condylar changes and suggest that the clinician should consider the role of condylar resorption in the development of skeletal relapse2.
In this study authors suggest that osteoarthrosis, some systemic conditions, vascular necrosis, overloading of condyle at surgery or after surgery play an important role in condylar resorption. Authors also indicate that large mandibular advancement, posteriorly inclined condylar neck and high mandibular plane angle are the predisposing factors. A diagnosis of condylar resorption was made by comparison of pre-operative and post operative orthopantomograms and cephalometric radiographs, as well as clinical evaluation. Based on treatment performed patients were divided into 2 groups, surgical and non-surgical group. Authors concluded that repeated surgery trigger condylar resorption3.
Condylar resorption after orthognathic surgery occurs more frequently in young female patients, intermaxillary fixation, and hypertonic musculatures have been reported as contributing factors. Changes in TMJ following orthognathic surgery particularly in case of mandibular hypoplasia, may be the main cause for condylar resorption. Author evaluated that the inclination of condylar neck in pre operative radiographs and attempt to illustrate their role in condylar resorption. Finally author concluded that condylar resorption was more observed when superior part of neck is inclined posteriorly4.
This is a retrospective study which has been done to find non-surgical risk factors for condylar resorption after orthognathic surgery. In this study a group 1 of 17 patients who developed post-operative condylar resorption, were compared with another group of 22 patients without post-operative condylar resorption. Possible non-surgical risk factors were evaluated by analyzing clinical and radiological data. Final result shows that high mandibular plane angle, posteriorly inclined condylar neck, smaller SNB angle and overbite are significantly more in group 1. Because of these factors, condylar resorption and temporomandibular joint dysfunction were more in group 15.
6.3 OBJECTIVES OF THE STUDY :
The main objectives of study is to
1.  Evaluate the condylar changes following orthognathic surgery.
2.  Evaluate decrease in height of ramus and posterior facial height.
7. / MATERIALS AND METHODS :
7.1 Source of data
Patients from Bapuji Dental College and Hospital from the Department of Oral and Maxillofacial and Reconstructive Surgery, Davangere.
7.2: Method of collection of data: (including sampling procedure if any)
Sample size: A total of 25 Patients, who had undergone orthognathic surgery in the Department of Oral and Maxillofacial and Reconstructive Surgery, Bapuji Dental College and Hospital, Davangere.
Age group: In between 14 to 40 years.
Methods – A diagnosis of progressive condylar resorption is to be made by comparison of pre-operative and post-operative radiographs (orthopantomograms and cephalometric radiograms), as well as clinical evaluations. The orthopantomograms and cephalometric radiographs need to be taken for each patient pre-operatively and post-operatively, which includes immediately after osteotomy, at 6 months and 24 months. Additional radiographs will be taken when required. The outline of the condyle and ascending ramus of both sides will be traced from each orthopantomograms. Then pre-operative and post-operative tracings are compared.
Study design :-
Statistical analysis will be carried out using paired student t-test and ANOVA test.
Inclusion Criteria :
·  Age group: 10 – 40 years.
·  Condylar resorption occur following orthognathic surgery.
·  Both the sexes can be evaluated.
·  Presence of high mandibular plane angle.
·  Bimaxillary cases with mandibular advancement.
Exclusion Criteria :
·  Patients suffering from craniofacial syndrome, a past history of condylar fracture, and condylar resorption due to systemic diseases such as rheumatoid arthritis and systemic lupus erythematosus are excluded.
·  Isolated chin procedure.
7.3: Does the study require any investigation or interventions to be conducted on patients or other humans or animals? If so, please describe briefly.
Yes, the study is conducted on the patients for the evaluation of the condylar resorption following orthognathic surgery.
7.4 : Has ethical clearance been obtained from your institution in case of 7.3
Yes, the ethical clearance has been obtained and the copy of same has been attached.
8. /

LIST OF REFERENCES:

1.  De Clerco CA, Neyt LF, Mommaerts MY, Abeloos JV, De Mot BM. Condylar resorption in orthognathic surgery: A retrospective study. Int J Adult Orthod Orthognath Surg 1994;9:233-239.
2.  Moore KE, Gooris PJJ, Stoelinga PJW. The contributing role of condylar resorption to skeletal relapse following mandibular advancement surgery. J Oral Maxillofac Surg 1991;49:448-460.
3.  Hoppenreijs TJM, Stoelinga PJW, Grace KL, Robben CMG. Long-term evaluation of patients with progressive condylar resorption following orthognathic surgery. Int J Oral Maxillofac Surg 1999;28:411-418.
4.  Hwang SJ, Haers PE, Sailer HF. The role of a posteriorly inclined condylar neck in condylar resorption after orthognathic surgery. J Cranio-Maxillofac Surg 2000;28:85-90.
5.  Hwang SJ, Haers PE, Seifert B, Sailer HF. Non-surgical risk factors for condylar resorption after orthognathic surgery. J Cranio-Maxillofac Surg 2004;32:103–111.
9. /

SIGNATURE OF CANDIDATE

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10. /

REMARKS OF THE GUIDE

/ Very significant study to assess the surgical outcome.
11. /

NAME AND DESIGNATION OF (in block letters)

11.1 Guide
11.2 Signature / Dr. KIRTHI KUMAR RAI
PROFESSOR AND HEAD
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY,
BAPUJI DENTAL COLLEGE AND HOSPITAL,
DAVANGERE-577 004.

11.3 Co-Guide (if any)

11.4 Signature

11.5 Head of Department

11.6 Signature / Dr. KIRTHIKUMAR RAI
PROFESSOR AND HEAD,
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY,
BAPUJI DENTAL COLLEGE 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. Vikas Aneja. “Evaluation of condylar changes in patients 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


6.11.2007

Davangere.

From

Dr. VIKAS ANEJA

I Year Post Graduate Student,

Department of Oral, Maxillofacial and Reconstructive Surgery,

Bapuji Dental College and Hospital,

Davangere.

To

The Chairman

Ethical committee,

Bapuji Dental College and Hospital,

Davangere.

Through

The Head of the Department

Department of Oral, Maxillofacial and Reconstructive Surgery,

Bapuji Dental College and Hospital,

Davangere.

Respected Sir,

Subject : Application for ethical clearance certificate for main dissertation.

I, Dr. Vikas Aneja, Post Graduate Student, doing my dissertation titled “EVALUATION OF CONDYLAR CHANGES IN PATIENTS FOLLOWING ORTHOGNATHIC SURGERY, A RETROSPECTIVE STUDY” need radiographs, 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,

Bapuji Dental College and Hospital,

Davangere. Yours sincerely

[Dr. Vikas Aneja]