Post graduate student department of oral and maxillofacial surgery rajarajeswari dental college and hospital, mysore road



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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

ANNEXURE-II

PROFOMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION


1


NAME OF THE CANDITATE

AND ADDRESS

(IN BLOCK LETTERS)


Dr. G. MADHAN

POST GRADUATE STUDENT

DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY

RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL, MYSORE ROAD,

BANGALORE – 74



2


NAME OF THE INSTITUTION

RAJARAJESWARI DENTAL COLLEGE

AND HOSPITAL, RAMOHALLI, CROSS,

MYSORE ROAD, BANGALORE-74




3


COURSE OF STUDY AND SUBJECT

MASTER OF DENTAL SURGERY

ORAL AND MAXILLOFACIAL SURGERY



4


DATE OF ADMISSION TO THE COURSE

16TH APRIL 2009




5


TITLE OF THE TOPIC: CHOUKROUN’S PLATELET RICH FIBRIN(PRF) VERSUS BIO-ABSORBABLE COLLAGEN MATRIX IN SOCKET PRESERVATION AFTER EXTRACTION FOR AN IMPLANT-A CLINICAL AND HISTOLOGIC STUDY.







6. BRIEF RESUME OF THE INTENDED WORK:


6.1 NEED FOR THE STUDY
Alveolar ridge atrophy is an unavoidable sequela of tooth loss which negatively influences dental implant placement1. Techniques for preservation of alveolar ridge dimensions have been proposed and evaluated in the literature2-3, and a variety of bone graft materials and barrier membranes have been suggested for their ability to enhance bone formation4 and their bone healing and bone-forming capacity in extraction sockets5.

The importance of growth factor in enhancing wound healing has become the focus of research in the present day6 .Platelet concentrate-an autologous growth factor in the form of platelet rich plasma(PRP) was introduced to dentistry by marx et al7. Platelet rich fibrin (PRF)-a 2nd generation platelet concentrate which has shown to have several advantages over PRP was introduced by choukroun et al8.



This study is aimed at comparing the efficacy of PRF as against the bio-absorbable collagen matrix9 for socket preservation after extraction.

6.2 REVIEW OF LITERATURE:


  • In a study, bio-absorbable collagen material alone was compared with bio-absorbable collagen mixed with putty P -15(a synthetic cell binding peptide) as a socket preservation graft material in 24 subjects after extraction of maxillary premolars. Clinical measurements were done immediately after the extraction and the measurements were repeated after 16 weeks and core bone biopsy was taken prior to implant placement. No stastically significant difference was observed in between the groups as far as reduction in alveolar height and width was concerned. But sockets with putty P -15 showed superior bone quality and a small percentage of remnant putty P -15 particles was observed on histological examination9.

  • In a pilot study involving 7 subjects with buccal wall extraction defects a mineralized bone collagen substitute (MCBS) combined with recombinant human platelet-derived growth factor –BB was used as a socket preservation graft material. surgical site re-entry was performed at either 4 or 6 months randomly. The bone quality was analyzed histologically and microcomputed tomography. Adequate viable bone was regenerated in the buccal wall defect to accommodate implant placement. The 4 and 6 months bone specimen were of equivalent quality wich was accomplished without a barrier membrane10.




  • In a study conducted to evaluate autologous platelet rich fibrin matrix (PRFM) alone in comparison with demineralized freeze dried bone allograft material (DFDBA) and membrane for ridge preservation following extraction, 4 mongrel dogs were treated individually with PRFM, PRFM and membrane, DFDBA and membrane, PRFM and DFDBA and control without any graft. Clinical and histological evaluation was done. In conclusion PRFM alone proved to be the best graft for ridge preservation procedure because of faster healing, it eliminates the disadvantages of using membrane and leaves no non viable material in the socket11.

  • In the study done to evaluate the bone regeneration potential of choukroun’s PRF in combination with freeze dried bone allograft(FDBA) in sinus floor elevation, 9 sinus floor augmentation were performed. In 6 sites PRF was added to FDBA (test group) and in 3 sites FDBA(control group) alone was used. Four months later for the test group and 8 months later for the control group, bone specimens were harvested from the augmented region during the implant insertion procedure for histologic analysis. After 4months of healing in test group and 8 months of healing in control group,both had bone of equivalent quality. It was concluded that PRF reduces the healing time by increasing the bone regeneration capacity at the implanted site12.

  • In this article author describes a new technique of preparing an autologous platelet concentrate without using calcium chloride, bovine thrombin or anticoagulant making the preparation a strict autologous platelet concentrate rich in growth factors. This new biomaterial called Platelet rich fibrin(PRF) is an autologous cicatricial matrix enhanced with growth factors which hastens the wound healing process8.


6.3 OBJECTIVE OF THE STUDY:


  • To evaluate and compare the bone dimensional changes clinically in extraction sockets with growth factor enhanced fibrin matrix (PRF) against bio-absorbable collagen matrix(COLLA PLUG).

  • To evaluate bone regeneration capacity of PRF.

  • To analyze and compare the histological variations




7. MATERIALS AND METHOD:
7.1 SOURCE OF DATA
This study will be done on the patients who report to the department of oral and maxillofacial surgery, Rajarajeswari Dental college and Hospital, Bangalore, requiring tooth extraction followed by implant placement.

7.2 METHOD OF COLLECTION
In this study 20 patients will be enrolled .These patients will be randomly divided into two groups :

Group I- Choukroun’s PRF group

Group II-Bio- absorbable collagen group (collaplug group)
INCLUSION CRITERIA


  • Patients in the age group of 18-60 yrs of either sex

  • Systemically healthy subjects

  • Sockets with intact four wall configuration.

  • Presence of atleast one tooth adjacent to socket for the preparation and adaptation of acrylic stent for measurements



EXCLUSION CRITERIA





  • Subjects with any major systemic illness




  • Subjects with a history of head and neck radiation therapy.




  • Cigarette smokers

7.3 STUDY METHOD
Patients fulfilling above mentioned criteria will be selected and randomly assigned to one of the two groups. Informed consent will be taken from the patient before the procedure.

Acrylic stents will be made on the study model including atleast one tooth adjacent to the tooth to be extracted to serve as a fixed reference guide for the vertical measurements done using a standardized periodontal probe. Horizontal ridge width is measured at the mid-point of alveolar crest.

At 4month follow-up prior to implant placement, vertical and horizontal measurements will be done using the same parameters.

Atraumatic extraction will be performed to preserve the alveolar bone in order to obtain a socket with four-wall configuration. Socket will be thoroughly debrided.



  • Group I-(PRF) :

Patients own blood is drawn into a sterile test tube without any anticoagulant which will be centrifuged for 12mins at 2700 rpm. PRF layer is taken out using a sterile tweezer and placed in to the socket.

  • Group II-(collaplug):

Collaplug is placed in to the socket

Buccal flap will be mobilized to allow tension free closure in both the groups and wound margins are stabilized with interrupted sutures. suitable medications will be prescribed.

Follow -up after a week for suture removal.

Follow –up after 4months for a re-entry procedure and implant placement. A bone core biopsy will be done with bone trephine prior to implant placement and the specimen sent for histological analysis.



STATISTICAL ANALYSIS :

  1. Fischer exact test

  2. Student 't' test

  3. Any other suitable statistical method will be used at the time of data analysis.

7.4 DOES STUDY REQUIRE INVESTIGATION OR INTERVENTION TO BE CONDUCTED ON PATIENT OR ANIMALS? IF SO EXPLAIN BRIEFLY :

Yes
Routine blood investigation


Radiographs

7.5 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.4?

Yes.


8. LIST OF REFERENCES :

1. Cardaropoli G,Araujo M,Hayacibara R,Sukekava F,Lindhe J.Healing of extraction sockets and surgically produced-augmented and non-augmented defects in the alveolar ridge. An experimental study in the dog. J Clin periodontal 2005;32:435-440


2. Artzi Z, Nemcovsky CE. The application of deprotenized bovine bone mineral for ridge preservation prior to implantation. Clinical and histological observations in a case report. J Periodontol 1998;69:1062-1067.

3. Wang HL,Kiyonobu K, Neiva RF. Socket augmentation; Rationale and technique. Implant Dent 2004;13:286-296.


4. Iasella JM, Green well H, Miller RL, et al. Ridge preservation with freeze – dried bone allograft and a collegen membrane compared to extraction alone for implant site development: A clinical and histologic study in humans. J Peridontol 2003;74:990 - 999
5. Araujo M G, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. . J clin periodontol 2005;32:212- 218.
6. Sunitha RV, Muniratnam NE. Platelet – Rich fibrin: Evolution of a second – generation platelet concentrate. Indian J Dent Res 2008;19(1):42-46
7. Marx RE. Platelet – rich plasma: evidence to support its use. J Oral Maxillofac Surg 2004; 62: 489- 496
8. Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part I: technological concepts and evolution. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2006; 101:e37-44
9. Rodrigo F, Neiva, Yi – PinTsao, Robert Eber, Jeffrey shotwell, Edward Billy, and Hom – Lay Wang. Effects of a putty – form hydroxyapatite matrix combined with the synthetic cell- binding peptide p–15 on alveolar ridge preservation; J Periodontol 2008;79(2):291-299.
10. Marc L.Nevins, Marcelo Camelo, Peter Schupbach, David M. Kim, Joao Marcelo Borges Camelo, Myron Nevins. Human histologic evaluation of mineralized collagen bone substitute and Recombinant Platelet – Derived growth factor – BB to create bone for implant placement in exraction socket defects at 4 and 6 months: A case series: Int J Periodontics Restorative Dent 2009;29:129-139
11. B I Simon, A.L. Zotcoff, J.J.W.Kong and S.M. O’ Connel. Clinical and histological comparison of extraction socket healing following the use of Autologous Platelet - Rich Fibrin matrix (PRFM) to Ridge preservation procedures employing Demineralized Freeze Dried Bone Allograft Material and membrane. The open dentistry journal, 2009;3:92-99
12. Choukroun J, Diss A, Simonpieri A, Girard M-O, Shoeffler C, et al. Platelet-rich fibrin (PRF):A second generation platelet concentrate. Part V: Histologic evaluations of PRF effects on bone allograft maturation in sinus lift. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2006;101:299-303.


9.

SIGNATURE OF THE CANDIDATE





10.

REMARKS OF THE GUIDE




11.

NAME AND DESIGNATION OF
11.1 GUIDE

11.2 SIGNATURE


DR MADHUMATI SINGH MDS PROFESSOR AND HEAD OF DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL,

MYSORE ROAD,

BANGALORE – 74






11.3 HEAD OF THE

DEPARTMENT
11.4 SIGNATURE



DR MADHUMATI SINGH MDS

PROFESSOR AND HEAD OF DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL,

MYSORE ROAD,

BANGALORE – 74




12.

12.1 REMARKS OF THE CHAIRMAN/PRINCIPAL

12.2 SIGNATURE






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