RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1. / NAME OF THE CANDIDATE AND ADDRESS / : / DR. JYOTHSNA CHOWDARYPOST GRADUATE STUDENT,
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY,
BANGALORE INSTITUTE OF DENTAL SCIENCES, BANGALORE-560029.
2. /
NAME OF THE INSTITUTION
/ : / BANGALORE INSTITUTE OF DENTAL SCIENCES AND HOSPITAL AND POST GRADUATE RESEARCH CENTRE, 5/3 HOSUR MAIN ROAD, BANGALORE-5600293. / COURSE OF THE STUDY AND SUBJECT / : / MASTER OF DENTAL SURGERY
PEDIATRIC AND PREVENTIVE DENTISTRY
4. / DATE OF ADMISSION TO THE COURSE / : / 03/06/2013
5. / TITLE OF THE TOPIC / AN EVALUATION OF THE TREATMENT OF THE SECONDARY ALVEOLAR CLEFTS WITH AUTOLOGOUS BONE GRAFT WITH AND WITHOUT PLATELET RICH PLASMA(PRP)- A CLINICO-RADIOGRAPHIC STUDY.
/ BRIEF RESUME OF THE INTENDED STUDY:
6.1 Need for the study:
PLATELET RICH PLASMA(PRP):PRP is an autologous source of growth factors which is obtained by sequestrating platelets. High concentration of platelets is seen in limited volume of plasma in platelet rich plasma. PRP clot consists of 95% of platelets, 4% of red blood cells and 1% of white blood cells. Platelets in PRP clot are more than 2 million per micro liter.1
Platelets in PRP release several growth factors such as
v Platelet Derived Growth Factor
v Transforming Growth Factors beta 1and 2
v Vascular Endothelial Growth Factor
v Epidermal Growth Factor
v Platelet Derived Angiogenesis Growth Factor
v Insulin Growth Factor
v Connective Tissue Growth Factor
v Basic Fibroblast Growth Factor
v Platelet activating factor-4
v Interlukin-1.2
These Growth Factors Aid In
· Hemostasis
· Angiogenesis
· Mitogenesis
· Chemotaxis
· Collagen Synthesis
· Bone Regeneration And Repair
· Rate , Quality And Strength of Wound Healing
· Hastens Remodeling.3
Reconstruction of bony defects in the alveolar cleft region is a challenging problem for surgical community.75% of all cleft lip and palate patients have osseous defects of the alveolus.The preferable time for the treatment of alveolar clefts with bone graft is in the
period of mixed dentition during ¼ and ½ root formation of canine. Bone graft provides adequate periodontal and bone support for the eruption and preservation of the teeth adjacent to the cleft.4
Failure to reconstruct the alveolar clefts may result in:
v Oro-nasal communication
v Fluid reflux
v Speech pathology
v Antero-posterior deficiency of the maxilla
v Transverse deficiency of the maxilla
v Lack of bone support for the incisors and cuspids
v Dental crowding
v Facial asymmetry.4
The alveolar clefts reconstruction can be achievedthrough an autologous bone graft and autologous platelet rich plasma.
6.2 REVIEW OF LITERATURE :
· The aim of alveoloplasty procedure is to facilitate dental eruption, re-establish maxillary arch, close any oro-nasal communication, give support to nasal ala, and in some cases allow dental rehabilitation with osteointegrated implants. The preferable time for alveoloplasty with bone graft is during mixed dentition period around 7-9 years when ¼ to ½ root formation of canine is complete. 20 cleft patients underwent secondary alveoloplasty. In 10 of them autogenous bone graft were used and in other 10 autogenous bone and platelet-rich plasma (PRP) obtained from autogenous blood. Bone formation was compared by digital orthopantomography made on immediate post-operatory and 3 and 6 months after the surgery. The authors could not justift the use of PRP for alveoloplasty in cleft patients' treatment protocol.5
· Study was done to analyse the efficacy of platelet-rich plasma in reduction of the resorption of the alveolar cleft bone graft. 20 nonsyndromic patients with unilateral alveolar clefts treated with alveolar bone grafting during the period between June 2005 and December 2008. The patients were randomly assigned to two groups: In Group 1: the patients treated by autogenous bone graft with Platelet-Rich Plasma. In Group 2: the patient treated by autogenous bone graft only. Clinical and radiological follow-up examinations were carried out at 1, 6 and 12 months. The osseous resorption method was evaluated with the use of digital panoramic radiograph. Authors concluded that more favourable result can be achieved with application of PRP to the alveolar bone graft.6
· In this study, alveolar bone grafting with autologous iliac cancellous bone incorporation with platelet-rich plasma (PRP)was done to evaluate its efficacy in osteoregeneration. Seven alveolar cleft patients of age 16 years underwent iliac bone grafting with PRP. Radiographic evaluation of regenerated bone was made with 3-dimensional computed tomography scans and compared with controls. They concluded that PRP is a safe and economical source of growth factors. PRP helps in enhancing the osteogenesis of alveolar bone.7
· To find the the best suitable method for treating patients with huge palatal defects. 20 children referred to the Department of plastic surgery in a Sulaimaniya Teaching Hospital suffering from cleft palate were treated by the use of decalcified xenogenic bone graft combined with platelets rich plasma which eliminate the need to harvest autogenous iliac bone graft. The above authors concluded that use of demineralized xenogenic bone graft combined with PRP is considered the best substitute for autogenous bone graft to treat cleft palate.8
· This study evaluated the closure of recurrent cleft palate fistulas using plasma rich in growth factors mixed with autologous bone graft.11 recurrent cleft palate fistulas that are closed with local mucoperiosteal flaps and placement of autologous bone graft mixed with plasma rich in growth factors. The above author have concluded that the use of plasma rich in growth factors mixed with autologous bone graft is an safe and cost effective for the closure of cleft palate.9
· Cleft of the lip, palate and alveolus are the commonest congenital anomaly to affect the orofacial region. Currently, there is great interest in the alveolar bone grafting procedures that involve use of platelet-rich-plasma (PRP), to enhance bone formation and specifically to promote bone graft healing. 20 patients with residual alveolar cleft, in the age group of 9–29 years, having unilateral or bilateral cleft lip and palate were selected. They were randomly assigned in either group A (with PRP) or group B (without PRP).The above authors concluded that on preliminary investigations, PRP seems to enhance bone formation in alveolar clefts when admixed with autologous cancellous bone harvested from the iliac crest.106.3 Objectives of the study:
To clinically evaluate the effectiveness of the autologous bone graft and autologous bone graft with PRP.
Radiographic evaluation using CBCT SCAN –(Kodak 9300 C) pre and post operatively to determine the length, width, height and density of bone in the alveolar cleft region
Clinical evaluation of the dental eruption and root formation of the teeth present along the line of the cleft.
MATERIALS AND METHODS :
7.1 Materials
Equipments used for platelet rich plasma preparation are
· Centrifuge machine
· Test tubes coated with anti-coagulants like citrate dextrose
· Thrombin
7.2 Source of Data:
The patients with alveolar clefts reporting to the department of oral and maxillo-facial surgery, BANGALORE INSTITUTE OF DENTAL SCIENCES AND HOSPITAL and MAHAVEER JAIN HOSPITAL.
/ 7.3 Method of Collection of Data:
The inclusion criteria:
Children with alveolar clefts between age of 8 – 12 years of both the genders.
Children with 1/4 root formation of canines.
Non syndromic individuals with blood count within normal limits.
Children with acceptance of autologous bone graft and secondaryalveoloplasty.
The exclusion criteria:
Children with Platelet disorders.
Medically compromised children.
Local infection at site of operation.
Children with long term medications in last 3months.
7.4 Method of studying:
A total of 24 Children with alveolar clefts are included in the study reporting to THE DEPARTMENT OF ORAL AND MAXILLO-FACIAL SURGERY IN BANGALORE INSTITUTE OF DENTAL SCIENCES, Bangalore and MAHAVEER JAIN HOSPITAL Bangalore. These children are randomly divided into 2 groups, control group and study group.
v CONTROL GROUP: Alveolar clefts are treated with autologous bone graft.
v STUDY GROUP: Alveolar clefts are treated with autologous bone graft and platelet rich plasma.
Pre-operative CBCT scan is taken to assess the size of the alveolar defect prior to the surgery.
Post operatively CBCT scan is taken 6 months after the surgery to determine the length, width, height and density of bone in both the groups.
In the study group, 10-40 ml of venous blood will be withdrawn into test tubes containing anti-coagulants like citrate dextrose 1hour prior to the surgery for preparation of platelet rich plasma.7 Blood collected in test tubes is centrifuged using platelet concentrating cell separators. Blood sample is centrifuged twice first being the soft spin and second the hard spin.2
7.6 Method Of Data Analysis :
Numerical data will be presented as MEAN and STANDARD DEVIATION.
Statistical analysis will be performed with, SPSS statistics windows version 20.
Results are subjected to Student t –Test and Paired t-Test.
Student t-Test is used to compare the pre-operative and post-operative changes.
Paired t-Test is used to compare the new bone formed after 6 months of surgery between both the groups.
If required any other suitable statistical method will be used at the end of data analysis.
7.7 Does the study require any investigation or interventions to be conducted
On patients or other humans or animals? If so, please describe briefly.
Yes. (format included)
7.8 Has ethical clearance been obtained from your institution?
Yes.
LIST OF REFERENCES:
1) Anila S and Nandakumar K. Applications of Platelet Rich Plasma for regenerative Therapy in Periodontics, Trends Biomater.Artif. Organs, (2006)vol20(1) 78-83
2) Kiran N, Mukunda K and Tilak R. Platelet Concentrates: A Promising Innovation in Dentistry, Journal of Dental Sciences & Research, february2011 vol 2 issue 12:1:50-61
3) Mikel Sanchez Isabel Andia, Eduardo Anitua and Pello Sanchez. Platelet Rich Plasma (PRP) Biotechnology: Concepts and Therapeutic Applications in Orthopedics and Sports Medicine.
4) Rani Somani, IrmanZaidi and ShipraJaidka_ Platelet rich plasma- A healing aid and perfect enhancement factor: review and case report, International journal of clinical pediatric dentistry, January – april2011 4(1):69-75
5) Ramon Lucas Rey , Jorge Arenaz-Bua , Jose-Luis Lopez-Cedrun-Cembranos, Susana Herrero-Patino , SheylaSironvalle-Soliva , Emma Iglesias-Canal, Maria Pombo-Castro. Is PRP useful in alveolar cleft reconstruction? Platelet rich plasma in secondary alveoloplasty, Med Oral Patol Oral Cir Bucal. July(2010) 1; 15(4):619-23.
6) Ayman F Hegab and Mohmmad A Shuman. Efficacy of Platelet Rich Plasma in reduction of the resorption of the alveolar cleft bone graft.A comparative study, (2012) ISSN:2161-1122 Dentistry volume 2 issue 7.
7) Tomoki Oyama, SohNishimoto, Tomoe Tsugawa and Fumaiki Shimizu. Efficacy of platelet rich plasma in Alveolar Bone Grafting, American Association of Oral and Maxillo Facial Surgeons (2004)62: 555-558.
8) Munther M. Radhi and Arie R. Zangana. Repair of the cleft palate with the use of demineralized xenogenic bone graft combined with platelet rich plasma, Oral and maxillofacial surgery and periodontology.2007vol.19(1).
9) Jorge Glicerio Gonzalez- Sanchez and Karina Jimenez- Barrangan. Closure of recurrent cleft palate fistulas with plasma rich in growth factors. Acta Otorrinolaringol Esp.2011;62: 448-53.
10) Chandan Gupta, DivyaMehrotra, Shadab Mohammad, VaibhavKhanna, Gulshan Kumar Singh, Geeta Singh, Arul A.L. Chellappa, Deepak Passi. Alveolar bone graft with Platelet Rich Plasma in cleft alveolus. Journal of oral biology and craniofacial research (2013)3-8.
11) Peter A.M. Everts, Johannes T.A, Gernot Weibrich, Jacques, Schonberger, Johannes Hoffmann, Henk A.M. Box .Platelet-Rich Plasma and Platelet Gel: A Review the journal of the American society of extra-corporeal technology 2006;38:174-187.
12) Platelet rich plasma (PRP) Guidelines , International Cellular Medicinsociety-2011.
13) Rani S, Irman Z, Shipra J. Platelet rich plasma-a healing aid and perfect enhancement factor: review and case report. International journal of clinical pediatric dentistry january-april2011;4(1):69-75.
14) Malik S, Sood M and Bindal D. Platelet-Rich Plasma: A Recent Innovation in Dentistry. Journal of innovative Dentistry, September-December(2011)volume 1,issue3.
15) SnehlataOberoi, RadhikaChigurupati, Pawandeep Gill, William Y. Hoffman, Karin Vargervik. Volumetric assessement of secondary alveolar bone grafting using cone beam computed tomography. Cleft palate-craniofacial journal, September 2009, vol. 46 no.5.
9. / Signature of The Candidate / (Dr. Jyothsna Chowdary.K)
10. /
Remarks of the Guide
11. / Name And Designation of(In Block Letters)
11.1 Guide
11.2 Signature / Dr. Kavitha Rai
Professor and HOD,
Departmentof Pediatric and Preventive Dentistry,
Bangalore Institute of Dental Sciences & Hospital, Bangalore.
11.3. Co-Guide
11.4. Signature / Dr. Krishna Murthy Bonanthaya
Professor,
Department of oral and maxillofacial surgery,
Bangalore Institute of Dental Sciences & Hospital, Bangalore.
11.5 Head of the department11.6 Signature / Dr. Kavitha Rai
Professor and HOD,
Departmentof Pediatric and Preventive Dentistry,
Bangalore Institute of Dental Sciences & Hospital, Bangalore.
12. / 12.1 Remarks of the Principal
12.2 Signature /
CONSENT FORM
The purpose of the study is to assess the new bone formation in the alveolar clefts with the aid of platelet rich plasma (PRP).
Preoperative radiographs (CBCT) will be taken 1 day prior to procedure.
Autologous bone graft will be collected from the patient for the closure of the alveolar clefts.
40 ml blood will be withdrawn from the subject on the day of surgery, 1 hr prior.
Post operative radiographs(CBCT) after 6 months from the date of surgery.
The undersigned agrees to voluntarily take part in the study. The purpose and procedure has been explained by the postgraduate student and all queries regarding the study has been explained to satisfaction .There is no risks foreseen in the above said procedure as PRP is prepared from the blood withdrawn from the same subject. All information and radiographs taken during the study will be held confidential. The results thus obtained from the study will be used solely for the purpose of academic research only.
I have understood the purpose of the study and the terms and conditions of the study. I thereby have agreed to be a part of the above said study.
Signature of parent/ guardian
Date:
Place of study:
ETHICAL CLEARANCE CERTIFICATE