THESIS – SYNOPSIS



DISSERTATION – SYNOPSIS

DR.BLESSIE ABRAHAM

POST GRADUATE STUDENT

DEPARTMENT OF PERIODONTICS

A.B. SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES

DERALAKATTE,

MANGALORE – 575018

KARNATAKA

Guided by: Prof. Dr. Biju Thomas

Professor and Head of the Department

Department of Periodontics

A. B. Shetty Memorial Institute of Dental Sciences

Deralakatte, Mangalore - 575018

Karnataka

Rajiv Gandhi University of Health Sciences, Karnataka

Bangalore

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

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|1. |Name of the Candidate and |DR. BLESSIE ABRAHAM |

| |Address |POST GRADUATE STUDENT, |

| |(In block letters) |DEPARTMENT OF PERIODONTICS, |

| | |A.B. SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, |

| | |NITYANANDA NAGAR P.O., |

| | |DERALAKATTE, |

| | |MANGALORE. – 575 018 |

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|2. |Name of the Institution |A.B. SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, |

| | |DERALAKATTE, |

| | |MANGALORE. – 575 018 |

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|3. |Course of study and subject |MASTER OF DENTAL SURGERY. |

| | |PERIODONTICS |

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|4. |Date of admission of course |31st MAY 2008 |

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|5. |Title of the topic |

| |COMPARATIVE EVALUATION OF POLYLACTIC POLYGLYCOLIC ACID COPOLYMER MATERIAL(FISIOGRAFT SPONGE™)AND OPEN FLAP DEBRIDEMENT IN INTRABONY |

| |PERIODONTAL DEFECTS – A CLINICAL AND RADIOGRAPHIC STUDY |

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|6. |Brief resume of the intended work: |

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| |Need for the study: |

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| |The primary goal of periodontal treatment is the maintenance of the natural dentition in health and comfortable function. When |

| |periodontal disease has caused a loss of the attachment apparatus, optimal care seeks to regenerate the periodontium to its |

| |pre-diseased state. Regeneration has been defined as the reproduction or reconstitution of a lost or injured part to restore the |

| |architecture and function of the periodontium. To be considered a regenerative modality, a material or technique must demonstrate |

| |that bone, cementum and a functional periodontal ligament can be formed on a previously diseased root surface. Bone grafts and their |

| |synthetic substitutes have been used in an attempt to gain this therapeutic endpoint1. |

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| |The different types of bone grafts are autogenous bone grafts, allografts, Xeno grafts and alloplasts. (FisiograftTM) is a synthetic |

| |product made from a co-polymer of polylactic acid and polyglycolic acid. It is biocompatible and well tolerated due to the fact that |

| |it is reabsorbed and degraded in the Kreb’s cycle. PLA-PGA Copolymer functions as a space maintainer and also has osteoconductive |

| |properties and is available in gel, sponge and powder form2. |

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| |Review of Literature |

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| |A study was done to evaluate the clinical outcome of reconstructive surgery in human deep intraosseous defects. |

| |Polylactide/polyglycolide (PLA/PGA) copolymer graft in conjunction with an open flap debridement procedure (test group) as compared |

| |to open flap debridement procedure alone (control group) was used. 32 patients were selected and divided into 2 groups with a 12 |

| |month follow-up period. Clinical recordings assessed at baseline, 6 months and 12 months proved that the additional use of PLA/PGA |

| |did not provide an additional benefit in terms of CAL gain and PD reduction compared with OFD procedure3. |

| |A study was done to compare the effectiveness of PLA granules to Decalcified freeze-dried bone graft and a flap procedure for |

| |debridement without graft in the treatment of periodontal intrabony defects. 10 patients presenting with advanced adult periodontitis|

| |including atleast 3 similar osseous defects comprising the study group were treated. Post surgery it was assessed that DFDBA produced|

| |a greater amount of osseous defect fill, FPD less fill and PLA the least amount of fill4.  |

| |A pilot study was done to evaluate the healing of large defects in the human jaw filled with PLG polymer by means of clinical, |

| |radiological and histological methods and to compare the results with those of platelet-rich plasma (PRP) clot or autologous bone |

| |(AB) fillings. 19 consenting males with bone cysts were split into 3 groups, packed with PRP, AB or PLG respectively. Postsurgery |

| |outcomes were best with AB graft, but suitable results were achieved using PLG to promote healing of severe bone defects5. |

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| |A study was done to evaluate the degree of bone mineralization in the alveolar sockets 3 months following the use of a bioabsorbable |

| |graft material (FisiograftTM). Evaluation of the degree of resorption of the grafted material was also done. The results indicated |

| |that the use of a bio-absorbable synthetic sponge of polylactide-polyglycolide acid did not interfere with the formation of new bone |

| |in the alveolar sockets. The biocompatibility, safety and characteristics of (Fisiograft TM) suggest that the material is suitable |

| |for filling alveolar sockets following extractions6. |

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| |A study was conducted in which polyglycolic-polylactic copolymer (FisiograftTM) was used in the treatment of periodontal intrabony |

| |defects. 2 cases were presented one with a periodontal abscess and damaged interradicular alveolar bone and the other case was in a |

| |patient with an extensive intrabony defect. After scaling and root planing both the defects were filled with the (FisiograftTM) |

| |material. 6months after the procedure the radiograph showed considerably reduced radiolucency, and the depth of the periodontal |

| |pocket was reduced by around 50%. In both the cases the application of (Fisiograft TM) proved successful in the process of healing |

| |alveolar bone damaged by periodontitis7. |

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| |6.3 Objective of the study: |

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| |To evaluate the clinical efficacy of PLA-PGA Copolymer sponge in the periodontal osseous defects. |

| |Radiographic assessment of the ability of PLA-PGA Copolymer sponge to bring about the bone fill in the intrabony periodontal defects.|

| |To evaluate its influence on clinical parameters like pocket probing depth and clinical attachment level. |

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| |Materials and methods |

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| |7.1 Source of data |

| |Subjects for the study will be selected from the out patients visiting the Department of |

| |Periodontics, A. B. Shetty Memorial Institute of Dental Sciences, Deralakatte |

| |Mangalore. |

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| |7.2 Method of collection of data. |

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| |The study is to be conducted on 10 patients between the age group of 25-50 yrs having intrabony periodontal defects on contralateral |

| |sides. |

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| |SCREENING EXAMINATION INCLUDES |

| |Medical history |

| |Dental history |

| |Periodontal status will be assessed using Gingival Index (Loe & Silness) and Plaque Index (Silness & Loe). |

| |Probing depth and clinical attachment levels will be measured using William’s graduated probe. |

| |Phase I therapy is to be carried out in all patients prior to the surgery and oral hygiene instructions are to be given. Clinical |

| |parameters like plaque index, gingival index, pocket probing depth and clinical attachment levels should be recorded at baseline. |

| |Radiographic assessment is to be done by taking orthopantomographs and Intra oral periapical radiographs prior to surgery. |

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| |SURGICAL PROCEDURES AND PLACEMENT OF THE GRAFT MATERIAL |

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| |The defects chosen are randomly assigned for either open flap debridement or for the placement of the copolymer sponge material. The |

| |surgical area should be anaesthetised, incisions are to be placed and a full thickness mucoperiosteal flaps are to be reflected to |

| |gain complete access to the defect. Defects are carefully debrided and the root surfaces are scaled and root planed thoroughly and |

| |then filled with the PLA-PGA Copolymer sponge upto the existing alveolar crest. Primary closure with the suture is obtained by tying |

|7 |knots. Sutures are also placed at the control sites after thorough debridement. Periodontal dressing is to be placed on the surgical |

| |areas. |

| |Patients should be prescribed antibiotics and analgesics for 5 days and are also instructed to use 0.2% Chlorhexidine mouthwash. |

| |Postoperative instructions are to be given and the patients have to be recalled on the 7th day for suture removal and after 1 month |

| |for check-up. Clinical parameters and radiographic assessments are to be done at 6 and 9 months postoperatively. Standardisation of |

| |the intraoral periapical radiographs will be done by the use of an intraoral grid. |

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| |CRITERIA FOR SELECTION: |

| |Inclusion Criteria |

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| |Subjects having intrabony defects on contralateral sides. |

| |Two or more vertical osseous defects. |

| |Defects as verified by radiographs with associated probing depth of ≥ 5mm following initial non surgical therapy. |

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| |Exclusion Criteria |

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| |Endodontically treated tooth with an existing lesion |

| |Teeth with furcation involvement |

| |Teeth subjected to occlusal disharmonies, severe attrition and excessive mobility |

| |Patient must not have taken antibiotic therapy in the past 3 months |

| |Patients with systemic diseases |

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| |STATISTICAL ANALYSIS |

| |The results obtained to be tabulated and subjected to statistical analysis using “Unpaired student t test”. |

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| |7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? |

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| |Yes, A thorough debridement of the intrabony periodontal defect will be done, following which the bone graft material will be placed.|

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| |7.4 Has the ethical clearance been obtained from your institution in case of 7.3? |

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| |Yes, Ethical clearance letter is enclosed. |

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| |List of references: |

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| |Paul S. Rosen, Mark A. Reynolds & Gerald M. Bowers: The treatment of Intrabony defects with bone grafts. Periodontology 2000, Vol 22,|

| |2000; 88-103. |

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| |GHIMAS, S.p.A.: Fisiograft product catalogue.Bologna:2005. |

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| |Minenna L, Herrero F, Sanz M, Trombelli L, Adjunctive effect of a polylactide/polyglycolide copolymer in the treatment of deep |

| |periodontal intraosseous defects: a randomized clinical trial. J Clin Periontol |

| |2005;32:456-461.doi:10.1111/j.1600-051X.2005.00696.x.@Blackwell Munksgaard, 2005. |

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| |4. Craig L. Meadows Marlin E Gher, George Quintero,and Thomas A.Lafferty: A Comparison of Polylactic Acid Granules and |

| |Decalcified Freeze-Dried Bone Allograft in Human Periodontal Osseous Defects |

| |J Periodontology 1993; Vol.64:103-109. |

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| |5. Carlo Bertoldi, Davide Zaffe and Ugconsolo: Polylactide/polyglycolide copolymer in bone defect healing in |

| |humans.Biomaterials:2008 Apr 29(12):1817-23.E Pub 2008 Jan 29. |

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| |6. Serino G, Rao W Iezzi G, Piattelli A: Polylactide and polyglycolide sponge used in human extraction sockets: bone formation |

| |following 3 months after its application. Clinical oral implants research, vol.19 Issue1; 26-31 oct-2007. |

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| |7. Marija Ivic-Kardum, Dubravka Skunca-Ograjsek, Davor Katanec, Mato Susic: Application of polyglycolic – Polylactic synthetic |

| |Co-polymer in Periodontal Intrabony Defects. Acta Stomatol Croat 2000; 213-217. |

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|9. |Signature of the candidate | |

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|10. |Remarks of the guide | |

|11. |Name & designation of: |PROF.DR.BIJU THOMAS |

| |11.1 Guide |HEAD OF THE DEPARTMENT |

| |(In block letters) |DEPT OF PERIODONTICS |

| |11.2 Signature | |

| |11.3 Co-guide (If any) | |

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| |11.4 Signature | |

| |11.5 Head of the department | DR. BIJU THOMAS |

| | |PROFESSOR |

| | |DEPT.OF PERIODONTICS |

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| |11.6 Signature | |

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|12 |12.1 Remarks of the principal: |

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| |12.2 Signature |

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