DR. rathore kapil praveen post graduate student department of oral and maxillofacial surgery



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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.RATHORE KAPIL PRAVEEN

POST GRADUATE STUDENT

DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY

NAVODAYA DENTAL COLLEGE AND HOSPITAL

RAICHUR – 584103, KARNATAKA.




2.

Name of the Institution

NAVODAYA DENTAL COLLEGE & HOSPITAL, RAICHUR, KARNATAKA.



3.

Course of Study and Subject

MASTER OF DENTAL SURGERY.

ORAL & MAXILLOFACIAL SURGERY.


4.

Date of Admission to Course

28-05- 2012



5.

Title of the topic

“EFFECT OF AUTOLOGOUS PLATELET RICH PLASMA ON PERI-IMPLANT BONE REGENERATION- A PROSPECTIVE CLINICAL STUDY”




6.

Brief resume of the intended work:

6.1 Need for the study:

Ever since the introduction of the concept of osseointegration, implants have gained significant ground in the field of dentistry. Osseointegration has been the ultimate goal for the dentists to achieve, and one of the pre-requisites for this to happen is that the immediate milieu around the dental implant must be conducive for proper healing and tissue regeneration.



Two predominant biologic factors in consideration of osseointegration and its success are:

  1. Enhancing interfacial bone formation (osteogenesis).

  2. Control of peri-implant bone resorption and micro motion effects on peri-implant osteogenesis.

With esthetics being the prima facia concern, the functional aspect has to match up to the expected level of patient. We need to find alternatives which not only satisfy the principles of surgical practice as far as healing is concerned but also are time effective. Autologous platelet rich plasma can prove to be quite a novel contributor in healing of bone where implants are placed in healed site.





6.2 Review of Literature:
Ullas Anand, D. S. Mehta1 conducted a study to clinically and radiographically assess the soft and hard tissue changes around the immediately loaded single tooth implants bioactivated with platelet-rich plasma (PRP), placed in the mandibular posterior region. A total of 11 patients having single tooth edentulous space in the mandibular posterior region were selected. An endosseous implant was placed after clinical and radiographic examination in each selected site using single stage surgical approach. The patients were followed up at 3, 6, 9, and at 12 months of post implant insertion. Radiographically, the peri-implant bone resorption both on mesial and distal sides were within normal limit after one year of immediate loading. Finally, the overall success rate for the immediately loaded bioactivated implant placed in the mandibular posterior region was recorded as 100%. The use of platelet-rich plasma may lead to improved early bone apposition around the implant; and thus, results in increased rate of osseointegration. Single stage implant procedure with the adjunctive use of PRP enhances the ability of peri-implant healing tissue to create favorable soft and hard tissue relationships. It also gives the added advantage of psychological boost for the patient by getting fixed replacement of tooth within a short time period.
Massimo Del 2 et al conducted a study to evaluate the clinical outcome of implant placed immediately placed in fresh extraction socket of teeth affected by chronic periapical pathologic finding, using plasma rich in growth factor as an adjunct during the surgical procedure. A total of 30 partially edentulous patients with teeth requiring extraction and chronic periapical lesions were included in the present study. A total of 60 transmucosal implants were installed immediately after extraction and careful debridement combined with PRGF’s placement into the socket. Before insertion, the implant surface was bioactivated by humidification with liquid PRGF’s. The overall implant success and survival rate was 98.4% at 1 year of function. The mean follow up was 18.5 months (range 10-21 months). The peri implant bone loss after 1 year averaged 0.41+/- 0.22 m. All patient reported full



satisfaction for mastication function, phonetics and esthetics. The use of PRGF’s combined with an immediate implant placement procedure can be considered a safe, effective and predictable treatment option for the rehabilitation of fresh post extraction infected socket.


Karan Marya et al3 conducted a study to evaluate the outcome of Endosseous implants placed in fresh extraction socket with and without use of platelet rich in growth factors. In this study 20 implants were used, out of which 10 implants were wetted and covered with PGRF and remaining were placed without any similar adjunct. The patients were prospectively evaluated for implant stability clinically, radiographically and using radiofrequency devices. It was observed that patients in the PGRF group reported lesser pain and swelling at the site of inflammation. The soft tissue healing in PGRF group was exemplary in experimental group the stability values showed an early recovery from the remodeling phase between 2nd and 4th weeks prospectively. In the study stability values after 12 to 24 weeks were approximately same for both groups. As the outcome of this study, it can be recommended PRGF as adjunct with implant, placed in fresh extraction sockets, as it may improve the success rate and decrease the treatment duration.
Su-Gwan Kim4 et al conducted a study to assess the efficacy of demineralized bone powder (DBP) alone or combined in a mixture with platelet-rich plasma (PRP) used to enhance osseointegration of dental implants in a dog model. Tissue integration was assessed using standard histomorphometric methods at 6 and 12 weeks after surgery. A total of 30 Avana dental implants (SooMin Synthesis Dental Materials Co, Busan, Korea) were inserted in the animals. They were self-tapping screw implants, 10 mm in length and 4 mm in diameter, made of commercially pure titanium. A titanium implant was then placed centrally in each defect.

In each dog, the defects were treated with 1 of the following 3 treatment modalities: 1) no treatment (control), 2) grafting with DBP, or 3) grafting with DBP and PRP. Histologic analysis showed that all of the bone defects surrounding the implants that were treated with DBP, with and without PRP, were filled with new bone. The defects that were not treated (control) showed new bone formation only in the inferior threaded portion of the implants. Histomorphometric results





7.

revealed a higher percentage of bone contact with DBP and PRP compared with control and DBP. These results suggested that bone defects around titanium implants can be treated successfully with DBP and that PRP may improve bone formation.


Gabor Fuerst et al5 conducted study to determine the effects of platelet-released growth factors (PRGF) on bone-to-implant contact (BIC) in Minipigs cortical bone. In each of 8 adult Minipigs, 2 implants were placed in the facial wall of the mandible, one implant with and one without PRGF. PRGF was defined as the supernatant from washed, thrombin-activated, allogenic, platelet-rich plasma cells obtained after centrifugation. Four animals were sacrificed at 4 weeks, and the remaining 4 were sacrificed at 8 weeks. For Histomorphometric analyses, undecalcified ground specimens were prepared and stained with the Levai-Laczko stain. Growth factors and other molecules released upon activation of platelet-rich plasma cells can enhance implant anchorage in cortical bone. PRGF obtained from allogenic sources does not impair healing. The results indicated that a single application of PRGF before implant placement can be sufficient to increase the percent BIC in Minipigs cortical bone.

6.3 Aims and Objectives of the study :

The aim of the present preliminary randomized clinical trial is to analyse the postoperative effect of autologous platelet rich plasma on peri-implant bone healing.


Material and Methods:

A total of 20 sample size is to be selected with missing mandibular molar. The samples would be duly divided into two groups. The 1st group is the control group comprises of 10 patients in whom implant will be placed without PRP this group will serve as a baseline for evaluating the success of implant placed in the study group using PRP. Simultaneously implants with PRP will be placed in the next group that is study group which comprises of 10 patients.







7.1 Source of Data.

Patients reporting to the Department of Oral and Maxillofacial Surgery, Navodaya Dental College and Hospital, Raichur, to replace missing mandibular posterior molar with implant rehabilitation will be selected for study with informed consent.



7.2 Method of Collection of the Data:

Patients reporting to the Department of Oral and Maxillofacial Surgery with missing mandibular posterior molar teeth, requiring a replacement of missing teeth.



Inclusion Criteria:

  1. Age:17-35 years

  2. Partially edentulous patient with missing posterior mandibular teeth (molar) without any periapical rarefaction for atleast 3months , as determined by clinical history and radiographic evaluation.

  3. Healthy subject.

  4. Gender: no specification

  5. Radiologically adequate (10-12mm) mesiodistal space for implant placement.

  6. Radiologically adequate bone height (10-15mm) for implant placement.

  7. Cessation of all deleterious habits related to the oral cavity, after the placement of implant during the course of the follow up.

Exclusion Criteria:

  1. Medical history should reveal no sickness that would influence the course of healing.

  2. Platelet count less than 1, 50,000.

  3. Pregnancy.

  4. Mentally challenged patients.








  1. Immunocompromised patient.

  2. Allergies or hypersensitivity to drugs, antibiotics, anti-inflammatory and cortisone medications.


Criteria for evaluation:


  1. Clinical photographs- pre-operative, intra-operative and post-operative.

  2. Pre operative periapical radiograph and OPG.

  3. During follow up-

Base line CBCT are taken immediately after implant placement, which will serve to compare the bone healing (in the form of bone density) in the follow up CBCT.

Then follow up is done after 1.5 months, 3 month and 6 months.



  1. The clinical parameters to be recorded are:

  1. The simplified oral hygiene index6.

  2. Probing depth around the implant at four sites- mesial, distal, buccal and lingual.

  3. Implant mobility according to clinical implant mobility scale.

  4. The absence or presence of any infection around the implant.



7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly.

  1. Orthopantomograph.

  2. Periapical radiograph.

  3. Routine blood investigations.

  4. CBCT.




8.





7.4 Has ethical clearance been obtained from your institution?

Yes.


List Of References:

  1. Anand U, Mehta DS: Evaluation of immediately loaded dental implants bioactivated with platelet-rich plasma placed in the mandibular posterior region: A clinico-radiographic study. Jr Indian Society of Periodontology 2012;16(1):89-95,




  1. Fabbro DL, Boggian D, Taschieri S: Immediate implant placed into fresh extraction sites with chronic periapical pathologic feature combined with plasma rich in growth factor: preliminary results of single-cohort study. J Oral Maxillofac Surg 2009;67:2476-2484.




  1. Marya K, Goyal M, Jhamb A, Chawla S, Aggarwal A: a comparative evaluation of outcome of endosseous implants placed in fresh extraction sockets with and without use of plasma rich in growth factors (PRGF). Int jr of oral implantology and clinical research, Sept- Dec 2010;1(3): 123-135.




  1. Kim S G, Kim W K ,Park J C, Kim H J: A Comparative Study of Osseointegration of Avana Implants in a Demineralized Freeze-Dried Bone Alone or With Platelet-Rich Plasma. J Oral Maxillofac Surg 2002;60:1018-1025.




  1. Fuerst G, Gruber R, Tangl S, Sanroman F, Watzek G: Enhanced Bone-to-Implant Contact by Platelet-Released Growth Factors in Mandibular Cortical Bone: A Histomorphometric Study in Minipigs. Int j oral maxillofac implants 2003;18:685–690.



  1. Greene JC, Vermillion JR. The simplified oral hygiene index. J Amer Dent Assoc 1964;68: 7-13.




9.

Signature of the Candidate




10.

Remarks of the Guide




11.

Name & Designation of Guide

(in block letters)

11.1 Guide

11.2 Signature


DR. CHITRA CHAKRAVARTHY

PROFESSOR AND HEAD,

DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY,

NAVODAYA DENTAL COLLEGE & HOSPITAL,

RAICHUR.






11.3 Co-Guide (If any)

11.4 Signature

DR. RAVI SEKHAR, PROFESSOR,

DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY,

NAVODAYA DENTAL COLLEGE & HOSPITAL,

RAICHUR.






11.5 Head of the Department


11.6 Signature



DR. CHITRA CHAKRAVARTHY

PROFESSOR AND HEAD,

DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY,

NAVODAYA DENTAL COLLEGE & HOSPITAL,



RAICHUR.



12

12.1 Remarks of the Chairman

& The Principal

12.2 Signature






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