RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA.
ANNEXURE – II
PROFORMA FOR THE REGISTRATION
OF
SUBJECT FOR DISSERTATION.
BY
DR. PRASHANT ASHOK PUNDE.
1ST YEAR MDS.
DEPARTMENT OF ORAL & MAXILLOFACIAL SURGERY
2008.
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
KARNATAKA
BANGALORE
ANNEXURE
PROFORMA
FOR REGESTRATION OF SUBJECT FOR DISSERTATION
1. NAME OF THE CANDIDATE DR. PRASHANT A. PUNDE.
& ADDRESS. POST GRADUATE STUDENT IN
DEPARTMENT OF ORAL & MAXILLOFACIAL
SURGERY ,
KRISHNADEVARAYA COLLEGE
OF DENTAL SCIENCES &
HOSPITAL, KRISHNADEVARA
NAGAR ,
HUNASAMARANAHALLI,
VIA ,YELAHANKA ,
BANGALORE 562157.
2. NAME OF THE INSTITUTION KRISHNADEVARAYA COLLEGE
OF DENTAL SCIENCES &
HOSPITAL.
3. COURSE OF STUDY & SUBJECT MASTER OF DENTAL SURGERY
ORAL & MAXILLOFACIAL
SURGERY
4. DATE OF ADMISSION TO COURSE 02-06-08
5. TITLE OF TOPIC USE OF MANDIBULAR SYMPHYSIS
BONE GRAFT WITH PLATELET RICH
PLASMA IN CORRECTION OF BONY
DEFECTS IN MAXILLA & MANDIBLE :
A CLINICAL STUDY.
6.BRIEF RESUME OF THE INTENDED WORK
6.1 NEED FOR THE STUDY
Success of graft depends on rate of bone formation & rate of bone resorption.. This in turn depends on revascularisation of graft. Larger part of cancellous bone grafts like iliac bone grafts are revascularised within 2 weeks as compared to the predominantly cortical bone grafts like symphysis bone grafts which when placed alone, take longer periods for revascularization.
That provokes need of certain material that when placed along with cortical graft, will accelerate vascularisation & ultimately accelerate remodelling of graft & according to literature Platelet-rich plasma (PRP) made from autologous blood is most cost effective & least time consuming to obtain.
Need for this study is to access the viability of autogenous mandibular symphysis graft along with platelet rich plasma in enhancing the revascularization & remodeling of graft.
6.2 REVIEW OF LITERATURES
Michael A. Pikos, DDS. Practiced this technique in more than 500 patients & stated that for repair of most localized alveolar defects, block bone grafts from the symphysis and ramus buccal shelf offer advantages over iliac crest grafts, including close proximity of donor and recipient sites, convenient surgical access, decreased donor site morbidity, and decreased cost. He concluded that overall morbidity of mandibular block autografts for alveolar ridge augmentation is minimal. Most complications are preventable, and those that occur can be handled predictably with minimal adverse effects to patients.5
Simon Z., Friedlich J stated that several graft materials available commercially may be effective for augmentation but cannot predictably induce the differentiation of bone forming cells.it has been speculated that using biologically active substances for bone regeneration is optimal.PRP plus bone grafting is expected to enhance and speed graft consolidation.6
Tomoki Oyama, MD,Soh Nishimoto, MD,Tomoe Tsugawa, MD and Fumiaki Shimizu, MD§ used PRP along with autogenous graft in alveolar clefts & stated that PRP was a safe and cost-effective source for growth factors and was easy to extract. It could enhance the osteogenesis of alveolar bone grafting in cleft lip and palate patients and may useful for subsequent orthodontic therapy.4
Robert E. Marx, DDS, a Eric R. Carlson, DMD, b Ralph M. Eichstaedt, DDS stated that Platelet-rich plasma is an autologous source of platelet-derived growth factor and transforming growth factor beta that is obtained by sequestering and concentrating platelets by gradient density centrifugation. This technique produced a concentration of human platelets of 338% and identified platelet-derived growth factor and transforming growth factor beta within them.1
Tiossi, r.; mello; lopes, r.; di mateo m. & iyomasa, stated that a recent innovation in dentistry is the preparation and use of platelet-rich plasma (PRP), a concentrated suspension of the growth factors found in platelets. PRP is involved in wound healing and are postulated as promoters of tissue regeneration.7
6.3 AIM
The present study is done to evaluate clinical & radiological efficacy of mandibular symphysis
autogenous onlay graft with platelet rich plasma in correction of bony defects in maxilla and/or mandible.
6.4 OBJECTIVES
· To determine donor and receptor site morbidity.
· To determine amount of vertical alveolar gain using coole’s method.3
· To evaluate success of graft using Bergland Scale for occlusal level of graft.2
7.0 MATERIALS AND METHODS
Autogenous corticocancellous bone graft harvested from patient’s mandibular symphysis region intraorally.
Titanium screws of diameter 1.5 mm with lengths varying according to thickness of graft placed.
Platelet rich plasma obtained from 10-20 ml of patient blood.
7.1 SOURCE OF DATA:
Patients visiting the Krishnadevaraya college of Dental sciences & Hospital, Bangalore.
7.2 METHOD OF COLLECTING THE DATA
Sample size includes minimum of 10 patients.
This study will be conducted in patients who have class B or class C type of maxillary and/or mandibular
bone according to Misch classification of available bone.
In this study 10 patients will undergo alveolar bone grafting with symphysis graft along with platelet
rich plasma.
Patients will be examined clinically at 1 week, 3 month & 5 months after graft placement.
Radiographs to be taken preoperatively and 5 months post-operatively.
INCLUSION CRITERIA
· Patients with type B or type C residual ridges according to Misch & Jody classification of available bone associated with less than 4 teeth in maxilla and/or mandible.
· Systemically healthy patient
· Patient willing to participate in the study
CLASSIFICATION OF AVAILABLE BONE ( MISCH & JODY)10
Type / Length / Width / HeightA / > 5mm / > 5mm / > 10-12 mm
B / > 5mm / 2.5 – 5.0 mm / > 10-12 mm
C / unfavourable / unfavourable / unfavourable
D / Basal bone loss / Severe atrophy / Flat maxilla pencil mandible
E / discontinuity / defect
EXCLUSION CRITERIA
1) Chronic smokers
2) Patient with inadequate donor site.
3) Those with large bony defect requiring augmentation that spans more than 3 teeth.
4) Medically compromised patients.
7.3. Does the study require any investigations to be conducted on the patients or other humans
or animals? If so please describe briefly?
a. Routine hematological investigations
( Hb%, BT, CT, TC ,DC, RBS, HIV, HBsAG )
b. Preoperative & postoperative study models
c. Photographs
d. Radiographs:
1. IOPA
2. Occlusal view
3. Orthopantamogram
7.4 Has ethical clearance been obtained from your institution in case 7.3 is applicable
YES
8. LIST OF REFERENCES
8. Journal References
1 . E. Marx, DDS, a Eric R. Carlson, DMD, b Ralph M. Eichstaedt, DDS Platelet rich plasma-
Growth factor enhancement for bone grafts
Oral Surg Oral Med Oral Pathol 1998;85:638-46.
2 . P.j. hynes, M.j. earley Assessment of secondary alveolar bone grafting using a modification of the
Bergland grading system
The British Association of Plastic Surgeons (2003) 56, 630–636.
3. J.Olekas, L.Zaleckas Late Results of the Secondary Alveolar Bone Grafting in Complete Unilateral
Cleft Lip and Palate Patients
Stomatologija, 2003 5:17-21.
4. Tomoki Oyama, Soh Nishimoto, Tomoe Tsugawa ,and Fumiaki Shimizu
Efficacy of Platelet-Rich Plasma in Alveolar Bone Grafting
J Oral Maxillofac Surg. 2004 May;62(5) :555-8
5. Michael A. Pikos Mandibular Block Autografts for Alveolar Ridge Augmentation
Atlas Oral Maxillofacial Surg Clin N Am 13 (2005) 91–107
6. Simon Z., Friedlich J use of autogenous bone grafting with PRP for ridge reconstruction: a clinical report
Dental abstracts september 2007 ,Calif dental assoc J 2006 34: 895-899
7. Tiossi, r.; mello; lopes, r.; di mateo m. & iyomasa PRP: A Possibility in Regenerative Therapy
Int. J. Morphol.,25(3):587-590, 2007.
Textbook References
8.BONE biology, harvesting and grafting for dental implants by Arun Garg.
9.Bone grafts and bone substitutes - Habal & Reddi.
10.Contemporary implant dentistry – Carl E. Misch.
11.Peterson’s principles of oral & maxillofacial surgery.
ANNEXURE – 1
BERGLAND SCALE FOR BONE GRAFT OCCLUSAL LEVELS.2
Type I – normal interdental bone level.
Type II – level greater than ¾ th of normal height.
Type III – level lesser than ¾ th of normal height.
Type IV – no bony bridge achieved.
9 SIGNATURE OF THE
CANDIDATE (DR. PRASHANT A. PUNDE.)
10 REMARKS OF THE GUIDE
11. NAME & DESIGNATION OF
(In Block Letters)
11.1 GUIDE DR. H. NANDAKUMAR
PROFESSOR & H.O.D
DEPARTMENT OF ORAL &
MAXILLOFACIAL SURGERY,
K.C.D.S.
BANGALORE
11.2 SIGNATURE
11.3 CO-GUIDE(IF ANY) DR. N. SRINATH
PROFESSOR
DEPARTMENT OF ORAL &
MAXILLOFACIAL SURGERY,
K.C.D.S.
BANGALORE
11.4 SIGNATURE
11.5 HEAD OF THE DEPARMENT DR. H. NANDAKUMAR
PROFESSOR & H.O.D
DEPARTMENT OF ORAL &
MAXILLOFACIAL SURGERY,
K.C.D.S. BANGALORE
11.6 SIGNATURE
12.1 REMARKS OF THE CHAIRMAN
& PRINCIPAL
12.2 SIGNATURE
ETHICAL CLEARANCE FOR DISSERTATION STUDY
Ethical clearance for dissertation study “USE OF MANDIBULAR SYMPHYSIS BONE GRAFT WITH PLATELET RICH PLASMA IN CORRECTION OF BONY DEFECTS IN MAXILLA & MANDIBLE : A CLINICAL STUDY” by DR.PRASHANT A. PUNDE. postgraduate student in the Department of Oral & Maxillofacial surgery, under the guidance of Dr. H. NANDAKUMAR , HOD, Department of Oral & Maxillofacial surgery , Krishnadevaraya College of Dental Sciences and Hospital, under Rajiv Gandhi University of Health Sciences, Karnataka.
Ethical committee meeting was held on 4th February 2009 in the Boardroom of Krishnadevaraya College of Dental Sciences & Hospital.
The Members discussed all the ethical issues involved
1. Review of literature and remarks of previous studies.
2. Risks and expected beneficial effects.
3. Cost factor.
4. Supervision by Senior Staff members.
5. ICMR guidelines for Research Studies.
The members were satisfied regarding all the above Ethical issues concerned and ethical clearance was granted for the Dissertation Study.
ETHICAL COMMITTEE MEMBERS
S.N / NAME & DESIGNATION / POSITION / SIGNATURE1 / Dr. H. Nandakumar, Principal & HOD Oral Surgery / Chairman &Convenor
2 / Dr. Sharathchandra, Prof & HOD, Dept of Cons. Dentistry / Co-chairman
3 / Mr. C.D.Somashekhar, Advocate / Member
4 / Mr. Gundu Rao, NGO, Social Activist / Member
5 / Dr. Jai Prakash Alva, Medical Supdt, KHRC / Member
6 / Dr. Prabhuji MLV, HOD Dept of Periodontics / Member
7 / Dr. Nikhilananda Hegde, HOD, Orthodontics / Member
8 / Dr. Raghavendra Rao, HOD, Conservative / Member
9 / Dr. Srinath, Professor, Oral Surgery / Member
10 / Dr. M.B.Radhika, HOD, Oral Pathology / Member
11 / Dr. P.C.Jacob, HOD, Prosthodontics / Member
12 / Dr. Ramegowda, Physician, KHRC / Member
Dr. H. Nandakumar.
Principal & Chairman
KCDS & H