RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
KARNATAKA, BANGALORE
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION.
1. / NAME OF THE CANDIDATE AND ADDRESS(IN BLOCK LETTERS) / DR.AJEYA KUMARA E G.
POST GRADUATE STUDENT,
DEPARTMENT OF PERIODONTICS,
V.S.DENTAL COLLEGE AND HOSPITAL,
BANGALORE.
2. / NAME OF THE INSTITUTION / VOKKALIGARA SANGHA DENTAL COLLEGE &HOSPITAL,
BANGALORE.
3. / COURSE OF STUDY AND SUBJECT / MASTER OF DENTAL SURGERY IN
PERIODONTICS.
4. / DATE OF ADMISSION TO COURSE / 21.05.2009
5. / TITLE OF THE TOPIC / “AUTOGENOUS CORTICAL BONE PARTICULATE HARVESTED USING A BONE SCRAPER FOR THE TREATMENT OF PERIODONTAL INTRAOSSEOUS DEFECTS-A CLINICO RADIOGRAPHIC OBSERVATIONAL STUDY”
6 / BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR THE STUDY:-
Periodontitis is an infectious disease of both hard and soft tissues. Changes that occur in bone are crucial because the destruction of bone is responsible for tooth loss. Numerous therapeutic grafting modalities for restoring periodontal
Osseous defects have been investigated. When the graft is obtained from the same individual, it is called as autograft.
Among the different available graft materials, autogenous bone grafts meet several ideal characteristics because it is potentially osteoinductive, bioabsorbable, cost effective and easy to handle.3Autogenous bone is the “gold –standard” for bone grafting (Jakse et al 2001; Gamradt and Liberman2003, mazock et al 2004) as it does not produce adverse reactions and has optimal biocompatible remodeling patterns(Matsuda et al 1992)and osteoinductive capabilities(Bunger et al 2003,hu et al 2004).3
Several methods are available for harvesting particulate bone. But almost all have some drawbacks. The most common method is to mill large bone portions. This requires additional and extensive surgical procedures to harvest block grafts. Further, treatment of transplant(graft) with bone mill or lifting transplants by rotating electrical instruments appears to reduce the amount of viable bone cells supplied(Springer et al 2004). Also, extensive surgical requirement cannot always be met in the dental office. Intraoral harvesting by bone scraper provides a simple, clinically effective regenerative procedure with low morbidity for collecting cortical bone chips.3The harvester collects bone on surfaces adjacent to defects from same surgical site, thereby avoiding an additional surgical procedure for bone graft harvestment.
The aim of this study is to assess the clinical and radiographic outcome of autogenous, intraoral cortical bone particulates obtained using an intraoral bone scraper in the treatment of periodontal intraosseous defects.
6.2 REVIEW OF LITERATURE:
A controlled clinical trial on 28 intraosseous lesions in 27 patients with advanced periodontits using autogenous cortical bone particulate and enamel matrix derivative resulted in reduced post-surgery recession with substantial clinical attachment level(CAL) gain(≥6mm).1
Atrophic edentulous alveolar crests were augmented in two patients using autogenous cortical bone particulate obtained using a bone scraper. Bone biopsy speciments were harvested at 9 months after graft placement. Analysis of the reconstructed bone revealed bone with lamellar quality characterised by a mature osteonic structure.2
A study was conducted to evaluate histologically the morphology and characteristics of bone chips harvested intraorally near bone defects and other sites by a specially designed cortical bone collector. It provided a simple, clinically effective regenerative procedure with low morbidity for collecting cortical bone chips(0.9-1.7mm in length, roughly 100µm thick).Chips had an oblong or quadrangular shape and contained live osteocytes (mean viability:45-72%).3
One study evaluated the viability of autogenous bone grafts obtained by using bone collectors. This histological and microbiological study showed that, if proper care is taken to prevent saliva contamination during the surgical procedure, this method of collecting autogenous bone may be useful in situations where small amounts of bone are required.4
A study conducted on 26 systemically healthy patients with diagnosed chronic and advanced periodontits using autogenous bone and platelet rich plasma. Total 72 infrabony pockets were treated. After 12 months, a mean value of attachment level regeneration of 3.47mm, pocket depth reduction of 3.7mm, tooth mobility reduction by 48.3% and alveolar bone regeneration by9.24% were noted.5
7 / 6.3 OBJECTIVES OF STUDY:
To assess the outcome of the treatment of intrabony periodontal defects with autogenous cortical bone particulate harvested by an intraoral bone scraper using:
-Clinical parameters using Plaque index(PI), Gingival bleeding index, Probing pocket depth, Relative attachment level(RAL), Marginal gingival level(MGL) and,
-Radiographic parameters.
MATERIALS AND METHODS:
7.1 SOURCE OF DATA:
Patients reporting to the Department of Periodontics, V. S. Dental College and Hospital, Bangalore.
7.2 METHOD OF COLLECTION OF DATA:
Fifteen patients fulfilling the following inclusion criteria will be included in the study. It will be made clear to all potential subjects that participation will be voluntary and written informed consent will be obtained from those who agree to participate.
INCLUSION CRITERIA:
1. Patients of either sex having chronic Periodontitis,
2. Patients who are systemically healthy with no contraindication to periodontal surgery,
3. Presence of periodontal pockets ≥ 5mm with radiographic evidence of intrabony defects,
4. Patients who are co-operative and able to come for regular follow up.
EXCLUSION CRITERIA:
1. Smokers,
2. Pregnant / lactating women,
3. Severe systemic disease,
4. Patients allergic or sensitive to any medication or any ingredient of the test
material,
5. Patients showing unacceptable oral hygiene compliance during / after phase
I therapy.
STUDY DESIGN
This will be a clinico-radiographic observational study.
Clinical parameters that will be recorded at baseline, 6, and 9 months are:
1. Plaque index (Silness and Loe 1964),
2.Gingival Bleeding index (Ainamo and Bay1975),
3. Probing pocket depth (PD),
4. Relative attachment level (RAL),
5. Marginal gingival level (MGL).
Assessment of post operative pain (using a Visual Analogue Scale) and post operative swelling will be done.
Radiographic assessment will be done at baseline,6, and 9 months.
The data will be subjected to appropriate statistical analysis.
FABRICATION OF ACRYLIC STENTS
Customized acrylic stents will be prepared on a study model for each patient using self-cure acrylic to fit over the selected teeth. A vertical groove will be made on the stent at the defect site which guides the probe penetration in the same plane. The stents will be preserved on the study casts for follow up measurements.
Probing pocket depth and clinical attachment levels will be recorded by UNC-15 probe with a stent. This will provide a well defined and reproducible clinical measurement at each site for each examination time point at baseline, 6, and 9months.
RADIOGRAPHIC ASSESSMENT
Intra oral periapical radiographs will be taken by long cone paralleling technique with XCP (DENTSPLY) positioning device. This will be carried out at baseline,6 and 9 months post operatively. The radiographic assessment will be done using image analysis software.
7.3 PROCEDURE
All patients will receive initial therapy consisting of oral hygiene instruction, scaling and root planing. Surgical procedures will be performed and will follow standard regenerative protocol. Following local anesthesia, intracrevicular incisions will be performed for reflection of full thickness mucoperiosteal buccal and lingual/palatal flaps for defect access and debridement. Defect debridement and root surface preparation will be accomplished using ultrasonic and hand instruments. Subsequently, the graft material harvested using bone scraper from same surgical site adjacent to the defects will be positioned. The surgical flaps will be repositioned to achieve primary closure. All patients will be prescribed doxycycline 100mg bid for 10 days postoperatively,0.12% of chlorhexidine oral rinse(bid for 4-6 weeks) and NSAIDS.
Recall examinations and maintenance therapy will be scheduled at 1week, 1, 3,6 and 9months post operatively. PD, RAL, BOP, PI & MGL will be measured at baseline, 6months and 9months.
Radiographic assessment will be carried out at baseline, 6 & 9 months recall. 7.4 DOES THIS STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMAN BEINGS?
YES, Routine investigations for periodontal surgery.
7.5 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3?
Yes.
8 /
LIST OF REFERENCES:
1. Luigi Guida, Macro Annunziata, Salvatore Belardo, Roberto Farina, Alessandro Scabbia, and Leonardo Trombelli: Effect of Autogenous Cortical Bone Particulate in Conjunction With Enamel Matrix derivative in the Treatment of Periodontal Intraosseous defects.J Periodontol 2007;78:231-238.
2. Leonardo Trombelli, Roberto Farina, Andrea Marzola, Giorgio Calura:GBR and Autogenous Bone Particulate by Bone Scraper for Alveolar Ridge Augmentation:A 2-case Report. Int J OrMaxillofac.Implants.2008;23:111-116
3. Zaffe D, D’ avenia F: A novel bone scraper for intra oral harvesting: A divice for filling small bone defects.Clin. Oral Impl. Res.18,2007;525-533
4. Alberto Blay, Samy Tunchel, Wilson Roberto Sendyk: Viability of autogenous bone grafts obtained by using bonecollectors:histological and microbiological study. Pesqui. Odontol. Bras. Vol.17 no.3 Sao Paulo July/Sept. 2003
5. Czuryszkiewicz-Cyrana J, Banach J: Autogenous bone and platelet-rich plasma(PRP) in the treatment of intrabony defects. Advances in Medical sciences. Vol.51.2006.suppl.1
9. /
SIGNATURE OF CANDIDATE
10. / REMARKS OF THE GUIDE /11. / NAME AND DESIGNATION OF:
11.1 GUIDE
11.2 SIGNATURE
11.3 CO-GUIDE
11.4 SIGNATURE
11.5 HEAD OF THE DEPARTMENT
11.6 SIGNATURE
/ DR. VINAYAK. S. GOWDA
(Associate professor)
DR. SUSHAMA R. GALGALI
(Professor )
12. / 12.1 REMARKS OF THE
CHAIRMAN AND PRINCIPAL
12.2 SIGNATURE
DEPARTMENT OF PERIODONTICS
V S DENTAL COLLEGE AND HOSPITAL, BANGALORE.
CONSENT FORM
I,...... Son/daughter of……………………………………………..
Aged………residingat…………………………………………………………….…………………………………………………………………………………………………………..Hereby giving consent to be included in this study. I am satisfied with the information of surgical procedure and explanation given to me about the study. I understand my rights and responsibilities as a participant in this study. I hereby voluntarily and unconditionally give my consent without any fear or pressure in mentally sound and conscious state to participate in this study.
Witness signature Patients/Parents Signature
Place:
Date:
DEPARTMENT OF PERIODONTICS
V S DENTAL COLLEGE AND HOSPITAL, BANGALORE.
CASE HISTORY
NAME: O.P.NO:
AGE/SEX: DATE:
OCCUPATION:
ADDRESS:
CHIEF COMPLAINT:
HISTORY OF PRESENT ILLNESS:
PAST DENTAL HISTORY:
MEDICAL HISTORY:
ANNEXURE II
Department Of Periodontics
V S Dental College and Hospital, Bangalore
CASE RECORD PROFORMA
Name: OP No:
Age/Sex:
Address: Occupation:
Ph:
CLINICAL PARAMETERS:
Tooth involved:
Baseline / 6 months / 9 monthsGingival Margin
Probing pocket depth
Relative attachment
PLAQUE INDEX( Silness & Loe,1964)
SCORING CRITERIA:
Scoring will be done at four areas: mesiofacial, facial, distofacial and lingual. After air drying, and using a mouth mirror and explorer.
Score / Criteria0 / Gingiva free of plaque. The surface is tested by running a pointed probe across the surface of tooth at the entrance of gingival crevice after the tooth has been dried. If no soft matter adheres to the point of the probe, the area is considered clean.
1 / No plaque can be observed in situ by the naked eye. A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which can be recognized only by running the explorer/pointed probe across the tooth surface or by using a disclosing agent.
2 / A thin, moderate accumulation of soft deposits within the gingival pocket or on the tooth and gingival margin, which can be seen by naked eye.
3 / Abundance of soft matter within the gingival pocket and/or on the tooth surface and gingival margin. The interdental area is stuffed with soft debris.
Plaque Score=Sum of scores of all surfaces/no of teeth examined
Rating / ScoresExcellent / 0
Good / 0.1-0.9
Fair / 1-1.9
poor / 2-3
GINGIVAL BLEEDING INDEX(Ainamo & Bay,1975)
SCORING CRITERIA:
Score / Criteria+ / Appearance of bleeding within 10 seconds of probing the gingival crevice gently with a periodontal probe
_ / Absence of bleeding
The index value is expressed as the sum of positive score divided by the total number of the gingival margins examined in percentage.
Gingival Bleeding Index Score=(Sum of positive scores/No of gingival margins examined)X100