RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA
SYNOPSIS
Subject for Dissertation
TITLE OF THE TOPIC
A COMPARATIVE EVALUATION OF DECALCIFIED FREEZE DRIED BONE ALLOGRAFT AND ITS COMBINATION WITH HYDROXYAPATITE IN OSSEOUS DEFECTS OF
MAXILLOFACIAL SURGERY
Guide:
Dr. K. Umesh
Professor and Head
Department of Oral and Maxillofacial Surgery
Submitted by:
Dr. TAMBOLI ABDULLAH NAVASAR
PG in Department of Oral and Maxillofacial Surgery
2012 Batch
AL-AMEEN DENTAL COLLEGE AND HOSPITAL
BIJAPUR
RAJIV GANDHI UNIVERSITY OF
HEALTH SCIENCES
BANGALORE, KARNATAKA
ANNEXURE – II
PREFORM FOR REGISTRATION OF SUBJECT FOR DESSERTATION
1. / NAME OF THE CANDIDATE AND ADDRESS (IN BLOCK LETTERS) / : / Dr. TAMBOLI ABDULLAH NAVASARAL-AMEEN DENTAL COLLEGE
BIJAPUR- 586108
2. / NAME OF THE INSTITUTION / : / AL-AMEEN DENTAL COLLEGE
BIJAPUR, KARNATAKA 586108
3. / COURSE OF THE STUDY AND SUBJECT / : / MASTER OF DENTAL SURGERY
(ORAL AND MAXILLOFACIAL SURGERY)
4. / DATE OF ADMISSION TO COURSE / 25TH MAY 2012
5. / TITLE OF THE TOPIC / “A COMPARATIVE EVALUATION OF
DECALCIFIED FREEZE DRIED BONE ALLOGRAFT AND ITS COMBINATION WITH HYDROXYAPATITE IN OSSEOUS DEFECTS OF MAXILLOFACIAL SURGERY”
6 / BRIEF RESUME OF INTENDED WORK
6.1 / NEED FOR STUDY:
Bone is a dynamic living tissue that shows marked structural alteration in response to injury, changes of stress and vascular, endocrine, genetic and nutritional influences. It is one of the few human organs that can undergo regeneration rather than repair with formation of scar tissue. Bone is a specialized connective tissue that provides support and protection for the delicate and vital organs of the body and also allows for locomotion.1
Healing is a complex procedure, which involves resorption and remodelling of alveolar crest which intern alters in the height and width of alveolar ridge and its contour.2
Various materials have been used immediately following minor oral surgical procedure to fill and cover the defect in an attempt to limit or prevent bony resorption and enhance the healing.3
The use of graft materials has been shown both clinically and histologically to improve new bone formation .Some clinical and histological studies documented positive healing responses with autogenous bone, allograft (decalcified freeze-dried bone) and xenograft, whereas ungrafted wound show poor healing, suture line break down , dehiscence and dry socket.2
The development of bone graft material to replace bone remains a formidable challenge in maxillofacial surgery. Although autogenous bone is the best material, however, the advantage of an auto graft is offset by the limited supply of such bone and morbidity associated with surgery to harvest the graft.4
Synthetic hydroxyapatite has been the most frequently used allograft material due to its chemical composition, similar to human bone. It is non-toxic, has a high chemical stability and causes less inflammation and antigenic reaction. Another important property is that its microstructure can be controlled to promote the formation of pores that can allow the migration of blood vessels and bone tissues into the material.5
The aim of study is to compare the efficacy of two such bone substitutes (DFDBA and hydroxyapatite) in the healing of osseous defects.
6.2 / REVIEW OF LITERATURE
1. / Sydney Nade et.al (1977) did a study on fate of decalcified allografts (homograft) of iliac cancellous bone impregnated with autologous red marrow and implanted intramuscularly into the anterior abdominal wall of rabbits.
2. / Lipa Bodner et.al (1996) radio graphically evaluated the changes that occur in jaw defects after enucleation of cysts and either grafting with demineralized Freeze-dried bone allograft (DFDBA) or packing with absorbable gelatine sponge.
3. / Augustine Bollo et al (1996) showed that success of graft depends upon a number of factors like source, size, function, and form of the bone graft necessary will influence decision making. This article presents the various forms of bone grafts, along with their applications in foot and ankle surgery.
4. / Hatem A. Alhadainy et al (1998) evaluated a hydroxyapatite – based material and calcium sulfate, when each was used under a resin modified glass ionomer cement to repair furcation.
5. / Michael Thorwarth et al (2005) conducted a study on bone formation in bony defects following the insertion of autogenous bone alone verses an injectable nanoparticle hydroxyapatite alone and in combination with 25% autogenous bone.
6. / ARENAZ-BUA. et al (2009) showed that autologus bone persists as the gold standard material for bone regeneration. Among the assessed biomaterials it has the best result. The study design is based on the extraction of two mandibular impacted third molar in a patient during the same surgical procedure by the same surgeon.
7. / Sonal Mishra et al (2009) showed that in hydroxyapatite graft there is delayed first evidence of bone formation as compared to the decalcified freeze dried bone allograft as it goes resorption after long time and it is replaced by bone.
6.3 / OBJECTIVE OF THE STUDY
1. To evaluate density of bone in defects of the jaws both preoperatively and postoperatively.
2. Compare the efficacy of DFDBA and HYDROXYAPATITE in healing of osseous defects of the jaw.
3. To assess the complications associated with this procedure.
7. / MATERIALS AND METHODS
7.1 / SOURCE OF DATA
Patients reporting to Dept of Oral and Maxillofacial Surgery, Al-Ameen Dental College and Hospital, Bijapur, with osseous defects, will be selected.
7.2 / METHOD OF COLLECTION OF DATA: (INCLUDING SAMPLING PROCEDURES IF ANY)
A total of 20 patients with osseous defect in oral and maxillofacial surgery department will be selected. The inclusion and exclusion criteria are given below.
The materials that are used are as follows
1) Decalcified freeze dried bone allograft (DFDBA)
2) Hydroxyapatite(HA)
DFDBA is available at various tissue bank with different product name and brand name.
Decalcified freeze dried bone allograft material is supplied by
From- TATA MEMORIAL HOSPITAL TISSUE BANK, Mumbai
Both granular and block form can be used depending upon defect.
Hydroxyapatite is also available at different forms like granules or blocks. the sample we are using is BIOGRAFT-HA.
Inclusion criteria :)
Ø Age: 18 to 55years.
Ø Both odontogenic and non odontogenic cystic defect.
Ø Any osseous defects in maxillofacial surgery.
Exclusion criteria:
Ø Systemically compromised patients.
Ø Patients unwilling for treatment.
Ø Infected bony cavity.
7.3 / DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTION TO BE CONDUCTED ON PATIENTS OR OTHER HUMAN OR ANIMALS? IF SO DESCRIBE BRIEFLY.
Yes
After obtaining written consent, necessary investigations include:
· Routine blood investigation.
· Radiological:
ü IOPA
ü Orthopantamogram.
ü Occlusal view
7.4 / HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3?
Yes
The ethical committee clearance has been obtained.
METHODOLOGY
Ø First patients with lesions of jaws were randomly divided into two groups.
Ø GROUP A with cystic defect to be treated with DFDBA
Ø GROUP B to be treated with DFDBA and HYDROXYAPATITE in equal volume.
Ø (both either in blocks or granular form)
Ø For both group initial treatment is same and it is as follow
Thorough pre-operative assessments including routine haematological investigation will be carried out in all patients.
Ø Orthopantamogram is taken before surgery if it is a jaw defect and iopa is taken if it is required.
Ø Surgery will be carried out under local anaesthesia or general anaesthesia depending on patient’s condition.
The graft material in group A approach for DFDBA graft placement is as follow.
The surgical approach involved routine reflection of a mucoperiosteal flap, exposing the jaw bone or cyst wall. After enucleation of the cyst, the bony defect
was packed with either DFDBA or DFDBA with HA combination .The wound was closed by suture.
Both the materials can be used either by making with normal saline paste or in mixing with patients own blood.
For GROUP B same procedure is performed except equal volume of hydroxyapatite is added into it
Evaluation:
Ø First postoperative day
Pain and swelling evaluated clinically and bone density radiographically with gray scale histogram.
Ø First postoperative week
Pain, swelling, and wound dehiscence evaluated clinically and bone density radiographically with gray scale histogram.
Ø Fourth postoperative week
Pain, swelling, wound dehiscence evaluated clinically and bone density radiographically with gray scale histogram.
Ø Twelth postoperative week
Pain , swelling, etc clinically and bone density radiographically with gray scale histogram.
Twenty fourth postoperative week
Same as above
LIST OF REFERENCES
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3.
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5.
6. / Sydney Nade,R. Geoffrey Burwell, do a study to examine the fate of decalcified allografts (homografts) of iliac cancellous bone impregnated with autologous red marrow and implanted intermuscularly into the anterior abdominal walls of rabit.-The journal of bone and joint surgery. Vol. 59-B,No. 2, May 1977
Mario Aimetti ,Federica Roman ,Fausto Baima Gria , Laura godio.Clinical and Histological Healing of human Extraction Socket Filled with Calcium Sulfate(Int J Oral Maxillofacial Implants 2009;24:901-909).
Stuart Froum. Sang-Choon Cho, Edwin Rosenberg, Michael Rohrer/ and Dennis Tarnow. Histological Comparison of Healing Extraction Sockets Implanted With Bioactive Glass or Demineralized Freeze Dried Bone Allograft: A Pilot Study. Periodontology January 2002 Volume 7 number 56 )
Bua AJ, Rey LA et al. A comparative study of platelet rich plasma, hydroxyapatite, demineralized bone matrix and autologus bone to promote bone regeneration after mandibular impacted third molar extraction. J of Med Oral Patol Oral Cir Bucal. 2010 May 1;15(3):E 483-9
Michael thorwarth bone regeneration in osseous defects using a resorb able nanoparticular hydroxyapatite. J Oral Maxillofacial surgery. 2005; 63:1626-1633.
ARENAZ-BUA. J. ET AL (2009) They studies the autologus bone persists as the gold standard material for bone regeneration. Among the assessed biomaterials has the best result. The study design is based on the extraction of two mandibular impacted third molar in a patient during the same surgical procedure by the same surgeon.
9 / Signature of the Student / :
10 / Remarks of the Guide / : / GOOD TOPIC
11 / Name and Designation of / :
11.1 Guide / : / Dr. K. UMESH M.D.S
Professor and Head
Department of Oral and
Maxillofacial Surgery
Al-Ameen Dental College and Hospital, Bijapur.
11.2 Signature / :
11.3 Co-Guide / : / Dr. N M WARAD M.D.S.
Professor
Department of Oral and Maxillofacial Surgery
Al-Ameen Dental College and Hospital, Bijapur.
11.4 Signature / :
11.5 Head of the Department / : / Dr. K. UMESH M.D.S.
Professor and Head
Department of Oral and
Maxillofacial Surgery
Al-Ameen Dental College and Hospital, Bijapur.
12 / 12.1 Remarks of the Chairman and Principal / :
12.2 Signature / :