RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA.

ANNEXURE II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1.

NAME OF THE CANDIDATE AND ADDRESS (In Block Letters)

DR. MOHAMMED ZIAUDDEEN. M, POST GRADUATE STUDENT, DEPARTMENT OF PROSTHODONTICS, BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANAGERE 577 004, KARNATAKA.

2.

NAME OF THE INSTITUTION

BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANGERE - 577 004.

3.

COURSE OF THE STUDY AND SUBJECT

MASTER OF DENTAL SURGERY , IN PROSTHODONTICS INCLUDING CROWN AND BRIDGE AND IMPLANTOLOGY.

4.

DATE OF ADMISSION TO COURSE

30 -05- 2011

5.

TITLE OF THE TOPIC

A COMPARATIVE STUDY OF CONDYLAR GUIDANCE SETTINGS OBTAINED FROM INTEROCCLUSAL RECORDS MOUNTED ON SEMI-ADJUSTABLE ARTICULATOR (ARTEX Type AR) WITH AND WITHOUT THIRD POINT OF REFERENCE AND LATERAL CEPHALOGRAPH IN EDENTULOUS SUBJECTS AN IN VIVO STUDY

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BRIEF RESUME OF THE INTENDED WORK:

6.1: Need for the study:

In prosthodontics, while we attempt to restore or replace missing tissues it becomes imperative to mount on an articulator with maxillary and mandibular casts, oriented to patients maxillo-mandibular relation to the hinge axis, for laboratory procedures. Facebow is a caliper-like instrument used to record the spatial relationship of the maxillary arch to some anatomic reference point or points and then transfer this relationship to an articulator.1 The use of two posterior points and an anterior point of reference for orienting a maxillary cast to an articulator has long been advocated.2 An anterior reference point is a physical requirement for orienting casts in the three dimensional space in an articulator.3 Improper positioning of the casts in an articulator may result in an inadequate restoration with an undesirable appearance and cause damage to the supporting structures.4 It is commonly seen in general practice, that we avoid using a facebow transfer with third point of reference and mount the cast in average values. This study aims, to compare the effect on the protrusive condylar registrations with casts mounted with anterior reference point and casts mounted in average value using Bonwills triangle and Balkwills angle5 , in Artex Type AR semi-adjustable articulator

(GIRRBACH DENTAL SYSTEMS, Germany). To compare the protrusive condylar guidance values registered on mountings with two different resultant reference planes to the protrusive condylar path angle relative to horizontal reference plane6 obtained from radiographic tracings.

6.2: Review of Literature: A study was done to evaluate the effect of four different anterior reference points on the protrusive condylar guidance registrations in Hanau wide vue semi-adjustable articulator. They compared the protrusive condylar guidance values registered on mountings with four different reference planes to the protrusive condylar path angle relative to Frankforts horizontal plane obtained from radiographic tracings. The author concluded that a change in anterior reference point in a facebow transfer caused a change in orientation of the occlusal plane and resulted in different protrusive condylar guidance values.7 A study was done to examine the cause and suggest methods to correct facebow transfer record errors that results when orbitale is used in conjunction with an articulator designed with the axis-orbital indicator plane parallel to the reference horizontal .The author concluded, that neither Frankfort plane nor the axis orbital plane were parallel to the reference horizontal in the esthetic reference position, the use of either plane as a reference horizontal in a facebow transfer record will place the maxillary cast too low in the articulator. A compromised esthetic result can be produced by the use of an anterior reference point not in harmony with the design of the articulator.4 A study was done to evaluate the ability of the operator to accurately mount the maxillary cast once the transverse horizontal axis has been located. This investigation determined the amount of error that accompanies the setting of facebow and the subsequent mounting procedure and concluded that kinematic facebow transfer record is accompanied by inherent errors in adjusting the instrument to the patient and then setting the instrument to the articulator. The adjusting of the anterior component to the anatomic third point of reference produces the least amount of error and the setting of the posterior components to their anatomic references produces the most amount of error. A small error of 0.5 mm is produced in adjusting the equipment to the articulator during the mounting procedure as demonstrated by the control method.8 3

A study investigated the variability of a group of dentists who used an arbitrary ear-facebow instrument to mount a maxillary cast and concluded that, the ear-facebow was found to be a consistent method of articulating the maxillary cast. Significant linear distance changes at the maxillary right first molar , tooth location/ dentist subject group interactions and differences among dentists-subjects were demonstrated.9 Another clinical study on 56 edentulous patients was done to determine statistically the inclination of the condylar path and to assess the reliability of evaluators using the tangential method of measuring and comparing the data. It was interesting to observe that there were considerable angular variations between left and right sides ranging from 0 to 25 degrees. It was concluded that the inclination of the condylar path is highly variable.10

6. 3 Objectives of the study : 1. To compare the condylar guidance values of edentulous patients obtained from interocclusal records with anterior reference point and mounting in Bonwills theory on Semi-adjustable articulator (ARTEX, GIRRBACH DENTAL SYSTEMS, Germany). 2. To compare the condylar guidance values recorded with the mountings from interocclusal records with the values obtained from radiographic tracings.

NULL HYPOTHESIS ( H0 ) : There will be no difference in the protrusive condylar guidance registrations in ARTEX TYPE AR semi-adjustable articulator with 2 different mountings and the value obtained by radiographic tracings. RESEARCH HYPOTHESIS ( H1 ) : There will be difference in the protrusive condylar guidance registrations in ARTEX TYPE AR semi-adjustable articulator with 2 different mountings and the value obtained by radiographic tracings. 4

7.

MATERIALS AND METHOD :

7.1: Source of data :

Ten completely edentulous patients required for the study will be selected, in accordance with the inclusion criteria mentioned below, from the Department of Prosthodontics, Bapuji Dental College, Davangere, for whom Complete Denture fabrication will be indicated.

Determination of sample size: Cohens d Method: d= X - X2

where X1 and X2 are mean values of two readings from pilot study, and is the standard deviation. For 80% power, from the table of cohens d

n = 10.
7.2 : Method of collection of data: The study will be conducted on ten patients after being fully informed about nature of investigation.

Inclusion Criteria for Selecting Edentulous Patients:

1. Class I ridge relationship. 2. Good Neuromuscular Control. 3. Firm and resilient mucosa. 4. No Signs and Symptoms of TMJ Disorder. 5. No History of Craniofacial Surgery/Trauma. 6. No Facial Asymmetries. 7. No Bony Abnormalities.

Exclusion Criteria for selecting Edentulous Patients : 1. Class II and Class III ridge relationship. 2. Poor Neuromuscular Control.
3. Facial Asymmetry. 4. TMJ Disorder. 5. Flabby ridges.

PROCEDURE:
Determination of Condylar Guidance : The standard steps of complete denture fabrication will be followed to obtain the master cast. After the fabrication of denture bases and occlusal rims, jaw relation will be recorded with standardized technique and maxillary cast will be mounted on a semi-adjustable articulator (ARTEX, GIRRBACH DENTAL SYSTEMS, Germany) using ARTEX ROTOFIX (GIRRBACH DENTAL SYSTEMS, Germany) facebow transfer. The third point of

reference considered here would be a point 43mm above the proposed incisal edge of the incisors on the wing of the nose. Mandibular cast will be mounted using centric relation interocclusal record .The protrusive interocclusal records will be made by asking the patient to protrude the mandible for 6mm.This record will be transferred to the articulator and the condylar guidance will be adjusted and the value obtained is recorded. The same occlusal rims will be mounted on the articulator using Bonwills theory with the centric relation record. The condylar guidance setting will be adjusted using the same protrusive interocclusal records made earlier. The condylar guidance value obtained is recorded.

A lateral cephalograph will be made with the occlusal rims intact in patients mouth, in centric relation. Another lateral cephalograph will be taken with the patients protrusive interocclusal record. The cephalographs will be overlapped for each side and will be traced. The protrusive condylar path11 will be obtained by joining the centres of the condyles in centric relation and in protrusive position. The angle formed by the protrusive condylar path and the horizontal reference plane will be recorded.

STATISTICAL ANALYSIS :
The values obtained for protrusive condylar guidance in two different mountings and the radiographic tracings will be analyzed using paired t-test and Wilcoxons signed rank test depending upon normality of data.

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 Measurement of condylar guidance values in edentulous patients using interocclusal records and lateral cephalographs, after taking informed consent. 7.4: Has ethical clearance been obtained from your institution in case of 7.3? YES The ethical clearance certificate has been obtained.

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LIST OF REFERENCES: 1. Glossary of Prosthodontic terms. J Prosthet Dent 2003; 94:10 - 92. 2. Bailey JO Jr, Nowlin TP. Evaluation of third point of reference for mounting maxillary casts on Hanau articulator. J Prosthet Dent 1984; 51:199-200. 3. Krueger GE, Schneider RL. A plane of orientation with an extracranial anterior point of reference. J Prosthet Dent 1986; 56:56-60. 4. Pitchford JH. A reevaluation of the axis-orbital plane and the use of orbitale in a facebow transfer record. J Prosthet Dent. 1991 Sep; 66(3):349-55. 5. Thure Brandrup-Wognsen. The facebow, its significance and application. J Prosthet Dent. 1953; 3(5):618-630. 6. M.Oliver Ahlers. Simulation of occlusion in Restorative dentistry

The Artex System.; 2000:119-123. 7. Deviprasad Nooji, Suresh M.C. Sajjan. The third point of reference and its effect on the protrusive condylar guidance angles obtained in semi-adjustable articulator. J Indian Prosthodont Soc. 2008; 8(2): 71-77. 8. Bowley JF, Michaels GC, Lai TW, Lin PP. Reliability of a facebow transfer procedure. J Prosthet Dent. 1992 Apr; 67(4):491-8. 9. Choi DG, Bowley JF, Marx DB, Lee S. Reliability of an ear-bow arbitrary face-bow transfer instrument. J Prosthet Dent. 1999 Aug; 82(2):150-6. 10. Zamacona JM, Otaduy E, Aranda E. Study of the sagittal condylar path in

edentulous patients. J Prosthet Dent. 1992; 68:314-317. 11. Hobo, Sumiya; Ichida, Eiji; Garcia, Lily T. Osseointegration and Occlusal Rehabilitation. Tokyo: Quintessence Publishing Co.; 1996:329-30. 12. Noel D .Wilkie. The anterior point of reference. J Prosthet Dent. 1979; 41(5):488-96.

BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANGERE DEPARTMENT OF PROSTHODONTICS

STUDY PROFORMA

A COMPARATIVE STUDY OF CONDYLAR GUIDANCE SETTINGS OBTAINED

FROM INTEROCCLUSAL RECORDS MOUNTED ON SEMI-ADJUSTABLE ARTICULATOR (ARTEX Type AR) WITH AND WITHOUT THIRD POINT OF AN IN VIVO STUDY REFERENCE AND LATERAL CEPHALOGRAPH IN EDENTULOUS SUBJECTS

Name of the investigator

Dr.Mohammed Ziauddeen.M Post graduate student INFORMED CONSENT

Guided by
Dr. Gautam Shetty Professor

I have been informed about the purpose, procedure and period of the study, the benefits and risks in the language that I understand in a comprehensible manner. It has also been assured to me that that the data collected during the course of the study will be maintained confidential. I hereby give consent voluntarily to participate in the study.

Signature of the participant

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PATIENT INFORMATION FORM

I am Dr. MOHAMMED ZIAUDDEEN.M , postgraduate student in the Department of Prosthodontics, Bapuji Dental College and Hospital, Davangere. I am conducting a research to compare the condylar guidance values obtained with interocclusal records and lateral cephalographs. The research procedure will involve making interocclusal records, facebow transfer and two lateral cephalographs. In the course of my study, I will be recording the upper and lower jaw position by two methods, and simultaneously take X-rays of the jaw positions. You will be given complete information about the research and requested to be part of the same. Please ask me to stop as we go through the information and I will take time to explain. You do not have to decide immediately whether you will participate in the research. You can make your decision about participation after going through the information given to you and talking to anyone, you feel comfortable with, about the research. Hereby, I assure you that the details obtained during the course of study will be kept confidential and will not be revealed to anyone. If you are not interested to participate in the research or if you feel uncomfortable, you can withdraw or can refuse to participate in the study at any time. With Regards,

NAME AND ADDRESS OF PRINCIPAL INVESTIGATOR: Dr. MOHAMMED ZIAUDDEEN.M, Postgraduate student, Room no: 7, Department of Prosthodontics, Bapuji Dental College and Hospital, Davangere. Mobile number: 9916065058.

If you experience any grievances while participating in this study, feel free to call to this number. Dr. K. Sadashiva Shetty: 08192 - 220575 (Member Secretary, Institutional Review Board)

Dr .L. Nagesh: 99844035470 12

(Member, Institutional Review Board)

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