Annexure II proforma for registration of subjects for dissertation



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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA BANGALORE
ANNEXURE - II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION


1.

Name of the Candidate &

Address (In block letters)



:

Dr. HARDIK DHOLAKIYA

POST GRADUATE

DEPARTMENT OF PERIODONTIA

HKE’s S.NIJALINGAPPA INSTITUTE OF DENTAL SCIENCES & RESEARCH, GULBARGA





Permanent Address

:

LUV-KUSH, H-43, HOUSING PLOT, G.I.D.C., WADHWAN CITY (363035), SURENDRANAGAR DISTRICT, GUJARAT.


2.

Name of the Institution

:

H.K.E. SOCIETY’S

S.NIJALINGAPPA INSTITUTE OF

DENTAL SCIENCES AND RESEARCH , GULBARGA

3.

Course of study and

Subject

:

M.D.S (PERIODONTIA)

4.

Date of admission to

Course

:

6th JUNE 2013

5.

Title of the Topic

:

IMPLEMENTING SOCKET SEAL SURGERY AS A SOCKET PRESERVATION TECHNIQUE BY USING HYDROXYAPATITE BONE GRAFT OVER NORMAL WOUND HEALING: A CLINICO-RADIOGRAPHICAL STUDY

6.

Brief Resume of the Intended Work




6.1

Need for the study:







Healing of an extraction socket is characterized by internal changes that leads to the formation of bone within the socket and by external changes that leads to the loss of alveolar ridge width and height [1].

The healing process following tooth extraction apparently results in a more pronounced resorption on the buccal aspect than the lingual/palatal aspects of the ridge [2].












As a result, in the case of advanced periodontitis, the width of the alveolar ridge is reduced and severe alveolar bone resorption occurs. These healing processes result in various complications-lack of available alveolar bone for implant placement, an unfavourable crown-implant ratio, as well as aesthetic problems in the anterior area.
Socket preservation is a procedure in which graft material or a scaffold is placed in the socket of an extracted tooth at the time of extraction to preserve the alveolar ridge. Various types of materials are used for this purpose, such as autogenous bone, allograft bone, xenograft materials, and alloplast materials [3-7].
Alloplast are synthetic materials that have been developed to replace human bone. They are biocompatible and are the most common type of graft materials utilized. The varying nature of commercially available pure graft materials, such as porosity, geometries, different solubilities, and densities, determines the resorption of these calcium phosphate-based (CaP) graft materials. The alloplasts are

osteoconductive materials [8].










Socket seal surgery, a simplified, minimally invasive regenerative approach, was introduced more than a decade ago as a tool for optimizing the preservation of the hard and soft tissue components of the alveolar ridge immediately following tooth extraction.[9]
This study describes the implications of hydroxyapatite over normal wound healing as hydroxyapatite has several potential clinical applications including the filling of bony defects, the retention of alveolar ridge form following tooth extraction and as a bone expander when combined with autogenous bone during ridge augmentation. It will also be helpful aesthetically and in proper ridge maintanance for patients who are willing for implants or fixed partial denture therapy.
There is much controversy surrounding the need for and efficacy of socket preservation. Some researchers argue that socket preservation cannot prevent the resorption of extracted socket walls, and that the quality of newly formed bone cannot be guaranteed due to graft materials. Others agree on the necessity of socket preservation,which can maintain the shape of soft tissue and hard tissue and reduce the need for an additional augmentation procedure. Hence this study is undertaken to evaluate the effects of hydroxyapatite bone graft over normal socket healing.[7]





6.1

Review of literature:







  • JANG-YEOL PARK et al clinically and histologically evaluated the results of using horse derived bone mineral for socket preservation.The study comprised of 4 patients who were scheduled for extraction. Extraction was followed by socket preservation to prevent alveolar bone resorption. The study concluded that horse derived bone mineral can effectively maintain ridge dimensions following tooth extraction and can promote new bone formation through osteoconductive activities.[10]

  • LAMBERT K AND VINCENT F et al described a new radiographic method to draw a map of alveolar bone remodeling after alveolar ridge preservation procedures to compare different surgical techniques.14 extraction sites in 14 patients located in the upper anterior maxilla were treated with bovine hydroxyapatite and a saddled connective tissue graft. A radiographic three- dimensional assessment of the hard tissues was performed at baseline and 3 months after procedure. The radiographic measuring methodology proved to be reproducible. It successfully assessed the alveolar ridge preservation technique (BHA + saddle connective tissue graft).[11]

  • ANTONIO BARONE et al reviewed a study of xenograft versus extraction alone for ridge preservation after tooth removal. Forty subjects who required extraction and implant placement were enrolled in this study. The subjects were randomly assigned to the control group (extraction alone) and the test group (ridge preservation with porcine bone and collagen membrane). The ridge preservation approach using porcine bone in combination with collagen membrane significantly limited the resorption of hard tissue ridge after tooth extraction compared to extraction alone.[12]

  • SERGIO ALLEGRINI JR et al presented a literature review about biomaterials applicable in alveolar ridge sockets preservation for future implants insertion. It concluded that the maintenance of alveolar bone after extraction depends on the attentive surgery procedure and the use of materials capable to maintain prior space and be helpful in bone tissue healing.[13]

  • EVMENIOS POULIAS et al reviewed a literature on ridge preservation comparing a socket allograft alone to a socket allograft plus a facial overlay xenograft. Twelve positive control patients received an intrasocket mineralized cancellous allograft while twelve patients received the same socket graft plus buccal overlay cancellous xenograft. The overlay treatment significantly prevented loss of ridge width and preserved or augmented the buccal contour. The socket and overlay groups healed with a high percentage of vital bone.[14]




6.3

Objectives of the study:
















  1. To evaluate the bone dimensional changes in control group of patients.

  2. To evaluate the bone dimensional changes in test group of patients pre- operatively and after socket preservation with hydroxyapatite bone graft and free gingival graft.

  3. To compare and correlate the clinical and radiographical parameters in both the groups.

7.

MATERIAL AND METHODS













7.1

Source of data







Study population comprises of 20 patients who requires tooth extraction and implant/fixed partial denture visiting the Department of Periodontology at H.K.E’s S.Nijalingappa Institute of Dental Sciences & Research, Gulbarga.













7.2

Methods of collection of data:







The subjects would be randomly assigned to the 1. group A i.e. control group consisting 10 patients(extraction alone) and 2. group B i.e. test group consisting 10 patients (socket preservation procedure with hydroxyapatite bone graft + free gingival graft to seal the socket).








Inclusion Criteria

  • Systemically healthy patients (ASA 1, 2)

  • Patients having simple gingivitis and controlled periodontitis

  • Males and Females within 18-50 years of age group

  • Patients who are willing to sign the informed consent

Exclusion Criteria

  • Pregnancy or lactation

  • Concurrent participation in another trial

  • Chronic generalised/localized aggressive periodontitis patients or patients having severe bone loss more than 80%.

  • Bone disease or the use of medications that interfered with bone metabolism

  • History of head and neck radiotherapy

  • Presence of dehiscence or fenestration on bone wall of the socket.










Procedure
1. Presurgical procedures

  • Clinical case history record and clinical photographs.

  • Standardised intraoral radiographs using RVG and grids will be taken pre-operatively (immediately after extraction).

  • Examination and assessment of the surgical site.

  • Preoperative medication regimen.

2. Clinical parameters will include:

a) buccal-palatal width b) mid-buccal crest height c) mid-palatal/lingual

crest height.

For the assessment of clinical parameters, A template will be fabricated

on the study model, including one tooth anterior and posterior to the

extracted tooth, to serve as a fixed reference guide for the vertical and

horizontal measurements.

Clinical evaluation is followed with radiographic evaluation at baseline and 3,6 and 9 months postoperatively.



  • Standardised intraoral radiographs using RVG and grids will be taken pre-operatively (immediately after extraction), post-operatively (immediately after graft placement) and 3,6 and 9 months post-operatively.










3. Surgical protocol

Surgical procedure will be done in group B patients after completion of presurgical therapy.

In group A patients, only observation (clinically and radiographically) would be done after extraction and at 3,6 and 9 months after extraction.

In group B patients after extraction,


Socket preparation would be done by debriding thoroughly of granulation tissue and residual periodontal ligament fibres followed by a thorough evaluation of the remaining bony housing.
Than hydroxyapatite bone graft would be placed inside the socket except 2mm coronally.

This is followed by Soft Tissue Grafting-


Preparation of the donor tissue: The donor tissue is obtained from the palatal masticatory mucosa in the area adjacent to the second premolar and the first molar. The outline of the graft should mimic the outline of the socket orifice, extending its diameter by 1 mm.
Stabilization of the soft tissue graft: Stabilization of the soft tissue graft atop the grafted bone may be achieved by suturing the graft to the surrounding socket walls. To allow adequate revascularization of the graft, no more than six to eight simple sutures are placed at the periphery of the graft. A monofilament polyamide or 7-0 polypropylene suture material is preferred to prevent infection.
5. Post operative care

The patient is instructed to follow the prescribed presurgery medication protocol, and a chlorhexidine mouthwash is prescribed for a 3-week duration post-surgically.


No tooth brushing or mechanical cleansing is allowed at the surgical area for 7 days.
Only a soft diet is advised for the first 2 weeks of the healing process.
Sutures will be removed 7-10 days after surgery.

6. Post surgical evaluation and review

Post surgical evaluation of hard and soft tissues will be done at 3, 6 and 9 months after surgery.

Hard tissue measurement will be done radiographically and clinically with previously used acrylic stents at 3,6 and 9 months post operatively.

















Statistical Data analysis
The paired t-test will be applied to assess the statistical significance between time points within each group for clinical and radiographic parameters. Student ‘t’ test will be applied to assess the statistical significance between time points to compare both groups for clinical and radiographic parameters.




7.3

Does the study require any investigation or intervention to be conducted on patients or other humans or animals? If so please describe briefly.






Yes, in this study extraction socket preservation is done by using bone graft and simultaneously socket sealed with autogenous free gingival graft.







7.4

Has ethical clearance has been obtained from your institution in case of 7.3?








Yes, ethical clearance has been taken from our institution for this study.


8.

List of References







  1. Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospec tive study. Int J Periodontics Restorative Dent 2003;23: 313-23.

  2. Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol 2005;32:212-8.

  3. Tal H. Autogenous masticatory mucosal grafts in extraction socket seal procedures: a comparison between sockets grafted with demineralized freeze-dried bone and deproteinized bovine bone mineral. Clin Oral Implants Res 1999;10:289-96.

  4. Becker W, Urist M, Becker BE, Jackson W, Parry DA, Bartold M, et al. Clinical and histologic observations of sites implanted with intraoral autologous bone grafts allografts. 15 human case reports. J Periodontol 1996;67:1025-33.

  5. Froum S, Cho SC, Rosenberg E, Rohrer M, Tarnow D. Histological comparison of healing extraction sockets implanted with bioactive glass or demineralized freeze-dried bone allograft: a pilot study. J Periodontol 2002;73:94-102.

  6. Vance GS, Greenwell H, Miller RL, Hill M, Johnston H, Scheetz JP. Comparison of an allograft in an experimental putty carrier and a bovine-derived xenograft used in ridge preservation: a clinical and histologic study in humans. Int J Oral Maxillofac Implant 2004;19:491-7.




  1. Darby I, Chen ST, Buser D. Ridge preservation techniques for implant therapy. Int J Oral Maxillofac Implants 2009;24 Suppl:260-71.

  2. Hoexter D.L.: Osseous regeneration in compromised extraction sites: a ten-year case study. J. Oral Implantol. 2002, 28, 19–24.

  3. Landsberg CJ, Bichacho N. A modified surgical/prosthetic approach for optimal single implant supported crown. Part I. The socket seal surgery. Pract Periodontics Aesthet Dent 1994;6:11-17.

  4. Jang-Yeol Park, Ki-Tae Koo et al: Socket preservation using deproteinized horse derived bone mineral J Periodontal Implant Sci 2010;40:227-231.

  5. Lambert F, Vincent K et al: A methodological approach to assessing alveolar ridge preservation procedures in humans:hard tissue profile.

  6. Antonio Barone,*† Nicolo` Nicoli Aldini et al: Xenograft versus extraction alone for ridge preservation after tooth removal: a clinical and histomorphometric study. J Periodontol 2008;79:1370-1377.

  7. Sergio Allegrini JR et al: Alveolar ridge sockets preservation with bone grafting – review 2008, 54, 1, 70–81.

  8. Evmenios Poulias et al: Ridge Preservation Comparing a Socket Allograft Alone to a Socket Allograft Plus a Facial Overlay Xenograft: A Clinical and Histologic Study in Humans. DOI: 10.1902/jop.2013.120585 .







9.

Signature of Candidate

:


10.

Remarks of the Guide

: THIS STUDY IS APPROVED FOR THE

MAIN DISSERTATION WORK.




11.

Name & Designation

(in block letters)





11.1 Guide

: Dr. JAYASHREE.A.MUDDA

M.D.S.

PROFESSOR & PRINCIPAL,

DEPT OF PERIODONTIA,

H.K.E.S’s S.N.DENTAL COLLEGE,

GULBARGA.





11.2 Signature

:




11.3 Co-guide

:

.





11.4 Signature


:




11.5 Head of the department

: Dr. VEENA A PATIL

M.D.S.

PROFESSOR & H.O.D.

DEPT OF PERIODONTIA,

H.K.E.S’s S.N DENTAL COLLEGE



GULBARGA.




11.6 Signature

:



12

12.1 Remarks of the Chairman and Principal

:





12.2 Signature

:


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