Annexure-ii proforma for the registration of subjects for dissertation



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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA

ANNEXURE-II

PROFORMA FOR THE REGISTRATION OF SUBJECTS FOR DISSERTATION


1.

Name of the Candidate and address

(In Block letters)

DR. MOHIT RANA

BLOCK BW FLAT NO. 62 C

SHALIMAR BAGH

DELHI 110088




2.

Name of the Institution

M.S. RAMAIAH DENTAL COLLEGE AND HOSPITAL

BANGALORE – 560054



3.

Course of study and Subject

MASTER OF DENTAL SURGERY (MDS)

ORAL AND MAXILLOFACIAL SURGERY



4.

Date of Admission to Course

31st MAY, 2012

5.

Title of the Topic

EFFICACY OF BIOGRAFT ( ß TRICALCIUM PHOSPHATE ) IN ALVEOLAR RIDGE PRESERVATION – A RANDOMIZED CONTROLLED TRIAL






6.

BRIEF RESUME OF THE INTENDED WORK:


6.1


NEED FOR THE STUDY:

Tooth extraction normally results in significant resorption of the alveolar ridge. The bone resorption process is initiated immediately after extraction, leading to an average 40–60% decrease in the horizontal and vertical dimensions of the alveolar ridge, during the first 2 years. The majority of post extraction bone loss is more evident on the buccal aspect of the ridge and occurs mainly within the first 3 months. These changes can make placement of a conventional bridge or an implant difficult.


Morbidity of donor sites, attempts at reduction in the number of surgical sites, and limitations in amount of bone available are some objective reasons driving the search of bone substitute to replace the use of autogenous bone.
According to previous studies ß TCP shows great osteoconductive potential because of its macroporosity (1 micron -1000 micron), which leads to good bone growth. Approximately 90% of this material is interconnected void spaces. ß-TCP bonds directly to bone, which facilitates healing.
Hence, the purpose of this study is to evaluate the efficacy of biograft (ß tricalcium phosphate) in alveolar ridge preservation.

6.2

6.3

REVIEW OF LITERATURE:

In a study, teeth were extracted and extraction sites were grafted with a pure phase ß tricalcium phosphate and covered with a membrane. Measurements of alveolar width were measured at time of extraction and at time of implant placement. Histomorphometric and histological analysis showed that ß tricalcium phosphate placed at the time of grafting extraction socket was well tolerated and there were no incidence of postoperative infection or rejection. At the time of implant placement, much of graft material had resorbed and been converted to vital alveolar bone. The implant recipient sites were dense and supported placement of endosseous dental implants that were fully stable. The width of extraction socket was preserved to 91% of the pre-operative width1.


A study reported the management of a maxillary tooth extraction socket using an alveolar preservation technique involving placement of a cone of beta-tricalcium phosphate (ß-TCP) combined with type I collagen without the use of barrier membranes or flap surgery. Clinical examination revealed solid new bone formation 9 months after the procedure. At the time of implant placement, histomorphometric analysis of the biopsied bone showed that it contained 62.6% mineralized bone, 21.1% bone marrow and 16.3% residual ß-TCP graft. The healed bone was able to support subsequent dental implant placement and loading.2
In a different study an injectable bone substitute (IBS- consist of 60% hydroxyapatite and 40% ß tricalcium phosphate) was used for filling bone defects after tooth extractions in 11 patients. The first objective of the study was to investigate the safety of the filler material. The second objective was to investigate the efficacy of the material for filling human tooth sockets and preventing alveolar bone loss. Radiographic density measurements of the surgical sites gradually increased to those of the surrounding host bone. Three years after surgery, small biopsies of the implanted areas were harvested and analyzed by using micro computed tomography, non-decalcified histology and histomorphometry. The BCP granules appeared in direct contact with mineralized bone tissue, thereby supporting bone growth. A gradual substitution of the filler by bone tissue was observed thus preserving the height

of the alveolar bone crest.3


In other study, a pure ß tricalcium phosphate coated with copolymer (polylactic –polyglycolic acid) used as a root analogue for filling of tooth socket. Three months later, the patient was planned for the placement of dental implants into the mandible. Biopsy taken during surgery on histological analysis revealed fibrous healing in area treated with root analogue. Results demonstrated that use of ß tricalcium phosphate coated with copolymers after tooth extraction enables satisfactory bone architecture for consequent implant treatment.4
In another study, after tooth extraction in 7 patients, extraction sockets were filled with mastergraft (15% hydroxyapatite, 85% ß-tricalcium phosphate complex). Radiomicrographs and histologic examinations were performed on samples obtained during dental implant placement procedure. On microYcomputed tomography, new bone was observed in all collected samples, and osteogenesis was observed to have taken place around the artificial bone substitute. Histologically, active osteogenesis was found throughout the region observed. Addition of new bone around the mastergraft was observed, and osteoblast-like cells were present. Cells that had partially invaded the artificial bone included tartrate resistant acid phosphateYpositive and

CD34-positive cells. These findings indicate that the mastergraft artificial bone induced osteogenesis in the jawbone and seemed effective for repairing bone defects.5



OBJECTIVES OF THE STUDY:
The objective of this study is to evaluate the efficacy of biograft (ß tricalcium phosphate) in alveolar ridge preservation.


7.


MATERIALS AND METHOD


7.1

7.2

7.3

7.4


SOURCE OF THE DATA:
Patients aged between 18-50 years, irrespective of sex reporting to the Dept. of Oral and Maxillofacial Surgery, M.S. Ramaiah Dental College and Hospital, Bangalore for the extraction of teeth.
Inclusion Criteria:

  1. ASA I (Healthy patient without any systemic disease) status as classified by the American society of anesthesiologists

  2. Tooth indicated for extraction e.g. fractured tooth, non-vital tooth without the possibility of endodontic treatment, endodontic treatment failure, and periodontal disease.

  3. Extraction socket with four intact walls after extraction of tooth.


Exclusion Criteria:

  1. Presence of any chronic systemic disease like diabetes, hypertension, bleeding disorder etc. that contraindicate surgical treatment.

  2. Allergy to local anesthesia or adrenaline.

  3. Chronic treatment with any medication known to affect bone turnover like heparin, cyclosporine, bisphosphonates, chemotherapeutic drugs – methotrexate etc.

  4. Pregnant or lactating women.

  5. Heavy smokers (a smoker with cigarettes consumption more than 20 pieces per day).


METHODOLOGY:
Study design: Randomized controlled trial
Sample size: From the literature review in a study done by Horowitz et al, it was observed that the preservation of alveolar ridge with or without ß tricalcium phosphate 91% and 50% respectively. In the present study to get a similar result in preservation of alveolar ridge in both groups (experimental and control group), with a precision of 80% power and 95% confidence level, we need a minimum of 18 subjects in each group.

Method of Collection of Data:
This is a clinical study on patients reporting to Dept. of Oral and Maxillofacial Surgery for the extraction of maxillary or mandibular teeth. All patients will be evaluated as per standard norms and selected according to the inclusion and exclusion criteria. The procedure will be explained and written informed consent will be taken from the patients.

Patients will be randomly allotted, to Group I or Group II with patients in each group.


Group I: Experimental group i.e. the socket preservation group in which after extraction, BIOGRAFT( BETA TRICALCIUM PHOSPHATE) will be placed and covered with collagen membrane
Group II: Control group wherein no graft will be placed and extraction socket will be left to heal normally

The patients will be evaluated for the following parameters clinically and radiographically on, the immediate postoperatively, 7th postoperative day, 4th month postoperatively and 9th month postoperatively.


Clinical Parameters:
HORIZONTAL DIMENSION

Distance between the central point of the buccal and palatal walls at the level of crestal bone with the help of bone caliper.


Untoward effects or local reaction as well as patient compliance will be monitored during the follow up period
Radiographic Parameters:
VERTICAL DIMENSION:

All measurements will be taken from the CEJ of the tooth adjacent to the tooth to be extracted; to the corresponding alveolar bone crest (ABC) and will be compared both pre and postoperatively.


BONE DENSITY :

With use of vista scan.


Statistical Analysis:

Descriptive statistics of preservation of alveolar ridge in both groups analysed and express in terms of percentage.


Fisher’s exact test would be used to compare the preservation of alveolar ridge in both groups.

Paired t test would be used to compare the change in the dimension of alveolar ridge pre and postoperatively.



DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTION TO BE CONDUCTED ON PATIENTS OR OTHER HUMAN OR ANIMAL? IF SO, PLEASE DESCRIBE BRIEFLY:
The study will be conducted on humans.

  • Investigations – Yes

    • Radiographs

- Vista scan

    • Blood investigations

  • Intervention – Yes

- placement of biograft ( ß tricalcium phosphate)

HAS ETHICAL CLEARANCE BEEN OBTAINED IN CASE OF ABOVE?
Yes, a copy of the certificate is enclosed.



8.

LIST OF REFERENCES:

1. Horowitz RA, Mazor Z, Miller RJ, Krauser J, Prasad HS , Rohrer MD . Clinical evaluationof alveolar ridge preservation with a beta-tricalcium phosphate socket graft.CompContEduc dent (Jamesburg, N.J.: 1995) 30(9):588-90, 592, 594 passim; quiz 604, 606.
2.Brkovic BMB, Prasad HS, Konandreas G, Radulovic M,Antunovic D, Sándor GKB, Rohrer M (2008). Simple preservation of a maxillary extraction socket using beta tricalcium phosphate with type I collagen: preliminary clinical and histomorphometricobservation. JCDA 2008 ;74:513–18
3. Weiss P, Layrolle P, Clergeau LP , Enckel BD, Pilet P , Amouriq Y, Daculsi G, Giumelli B. The safety and efficacy of an injectable bone substitute in dental sockets demonstrated in a human clinical trial Biomaterials 2007; 28: 3295–305
4. Vladimir Koković, Ljubomir Todorović. Preimplantation filling of tooth socket with β-tricalcium phosphate/polylactic-polyglycolic acid (β-TCP/PLGA) root analogue:

clinical and histological analysis in a patient. Vojnosanit Pregl 2011; 68(4): 366–71.


5.Mari Wakimoto, DDS, Takaaki Ueno, DDS, PhD, Azumi Hirata, DDS, PhD, Seiji Iida, DDS, PhD,Tara Aghaloo, DDS, MD, PhD, and Peter K. Moy, DMD. Histologic Evaluation of Human Alveolar Sockets Treated With an Artificial Bone Substitute Material. J Craniofac Surg 2011;22: 490-93
6. Kao, S.T.; Scott, D.D.A Review of Bone Substitutes.Oral and Maxillofacial Surgery Clinics of North America 2007;19( 4): 513-21




h:\scanned sign\mohit sign.jpg

h:\scanned sign\mohit ethics 1.jpg
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY
M.S.R.D.C


INFORMED CONSENT FORM
TITLE: EFFICACY OF BIOGRAFT (ß TRICALCIUM PHOSPHATE ) IN ALVEOLAR RIDGE PRESERVATION – A RANDOMIZED CONTROLLED TRIAL.
UNDERTAKING BY THE INVESTIGATOR:

Your consent for the above study is sought. We undertake to maintain complete confidentiality regarding the information obtained from you during the study. If you have any doubts regarding the study, please feel free to clarify the same. The list of investigators and their contact numbers are below:



Dr. R.M LALITHA: 9448460933

Dr. MOHIT RANA: 9035724036

CONSENT

I have been informed about the purpose and procedures of the study. I understand that if I give my consent for the study, I will have to provide the necessary details required for the study and co operate for measuring the accessibility and exposure of the fracture site, aesthetic results and postoperative complications.

I, give my consent to be a part of this investigation.

Signature of the investigator. Signature of the subject.

Date:

Place:


M. S. Ramaiah Dental College & Hospital

Consent for surgery
I ………………………………… Understand that I / My………………………………

(Name of patient / relative)

Am / is suffering from …………………… I / My ……………………………………..

(Diagnosis / symptoms)

Have / has been advised to undergo……………………………………………………..

(Name of Proposed procedure)

I / on behalf of my……………… hereby authorized Dr. ………………………………

and / or such associates and assistant as may be designated by him / her, to treat me/ my………………………….

The proposed surgery / diagnostic procedure has / have been explained to me adequately in my language and I understood that it means….…………………………………

………………………………………………………………………………………….....

(Name of procedure, tests test etc., in simple language as understood by patient) After having understood all above, I do not hold the hospital, medical or paramedical staff responsible for mishap that could occur from bonafide action.

Signature of patient / Guardian

Hosp. No. Date:

Signature:

Name:

Date:
Signature of Doctor



Date:


CASE HISTORY PROFORMA DATE:
STUDY GROUP:

NAME: AGE: SEX:

OCCUPATION: O.P. No.:

ADDRESS: MSRDC:
PHONE No.
CHIEF COMPLAINT:

HISTORY OF PRESENTING ILLNESS:


PAST MEDICAL HISTORY:

DRUG ALLERGY:
PERSONAL HISTORY:
GENERAL PHYSICAL EXAMINATION:

BUILT:

NOURISHMENT:

LEVEL OF CONCIOUSNESS:

VITALS:

B.P:

P.R:

R.R:


Pallor:

Icterus:

Cyanosis:

Clubbing:

Kylonychia:

Lymphadenopathy:

Edema:

Sleep:

Appetite:

Bowel and bladder:

Menstruation:


INTRA-ORAL EXAMINATION:
LABIAL MUCOSA:

BUCCAL MUCOSA:

PALATE:

TONGUE:

FLOOR OF THE MOUTH:
OCCLUSION:

DENTITION:

TEETH PRESENT:


INVESTIGATIONS:

ROUTINE BLOOD INVESTIGATION:

DIAGNOSIS:

TREATMENT PLANNING:

FOLLOW UP

HORIZONTAL DIMENSION:


Tooth number

Immediate

postoperatively



7th day postoperatively

4th month postoperatively

9th month postoperatively































VERTICAL DIMENSION:





Tooth number

Immediate

postoperatively



7th day postoperatively

4th month postoperatively

9th month postoperatively































RADIO DENSITY as compared to preoperatively:




RADIODENSITY

Tooth number

Immediate

postoperatively



7th day postoperatively

4th month postoperatively

9th month postoperatively

No Change
















Increase
















Decrease




















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