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. BEBIKA DEVI THOUDAM
DEPARTMENT OF PERIODONTICS,
BANGALORE INSTITUTE OF DENTAL SCIENCES, 5/3, HOSUR MAIN ROAD, BANGALORE-560029.
2 / Name of the Institution / BANGALORE INSTITUTE OF DENTAL SCIENCES AND HOSPITAL AND POST GRADUATE RESEARCH CENTRE, BANGALORE-560029.
3 / Course of study and subject / MASTER OF DENTAL SURGERY(MDS),
PERIODONTICS.
4 / Date of Admission / 19/04/2011
5 / Title of the Topic / “COMPARATIVE EVALUATION OF MICROSURGICAL AND CONVENTIONAL OPEN FLAP SURGICAL PROCEDURE IN PATIENTS WITH PERIODONTITIS – A CLINICAL, HISTOPATHOLOGICAL SCANNING ELECTRON MICROSCOPY STUDY.”
6 / BRIEF RESUME OF THE INTENDED WORK:
6.1  Need of the study:
Periodontal microsurgery is a refinement of basic surgical technique, made possible by improvement in visual acuity by the use of magnification. It improves the surgical ability and decreases the tissue trauma at the surgical site and thus helps in achieving passive and primary wound closure.
The principal goal of periodontal therapy is elimination of the etiological agent. Complete removal of calculus is of prime importance in achieving a healthy periodontal environment. Open flap debridement is considered to be a basic time tested technique in the treatment of periodontal disease. However, not much has been reported about the use of microsurgery exclusively in open flap debridement. Moreover, root surface changes following scaling and root planning by various methods such as rotary instruments, curettes and ultrasonic instruments have been evaluated, however there have been no studies done so far to assess these changes using the microsurgical approach.
Hence, this study is an attempt to clinically evaluate and compare the outcomes of microsurgery and conventional surgery in open flap debridement procedures in patients with periodontitis. In addition, the healing outcomes and root surface changes that occur in both the methods will also be assessed and compared by histopathology and scanning electron microscopy. .
6.2  Review of literature:
Schwarz JP, Guggenheim R, Düggelin M, Hefti AF, Rateitschak-Plüss EM, Rateitschak KH. (1989) evaluated human tooth roots by means of scanning electron microscopy (SEM), after treating the root surfaces either with conventional hand instruments or with newly developed diamond burs. On 20 teeth destined for extraction because of severe periodontitis, the root surfaces were exposed by mucoperiosteal flap procedures. Ten roots were then planed using fine curettes, and 10 were instrumented using diamond burs. Following extraction, the root surfaces were stained and photographed. Stained areas were examined by SEM. On the 20 test teeth, 79 surfaces were evaluated. From these, 381 stained zones were checked by SEM for the presence of bacteria. A total of 216 stained areas from teeth treated by hand instruments were evaluated; 15 of these (6.9%) contained bacteria. Of roots treated by diamond burs, 165 stained areas were evaluated; 9 (5.5%) exhibited bacteria. Thus, both methods resulted in root surfaces that were essentially bacteria-free1
Wikesjö UME, Crigger M, Nilveus R, Selvig KA(1991) assessed early healing
events in periodontal surgical wounds at the dentin-connective tissue interface by light and transmission electron microscopy and found granulation tissue formation may be visualized within three days of healing of the dento-gingival interface. Seven days following wound closure, the wound site is dominated by a cell-rich granulation tissue with fibroblasts and young collagen fibers.2
Wachtel H, Schenk G, Bohm S, Weng D, Zuhr O, Hurzeler MB (2003) assessed the clinical effect of the microsurgical access flap treatment with an emphasis on the evaluation of early wound healing. Eleven patients displaying at least one pair of intrabony periodontal defects with an intrabony component of ≥3mm participated in the study. At baseline and at 6 and 12 months after surgery, the following clinical parameters were assessed by a blinded examiner: oral hygiene status (API), gingival inflammation (BOP), probing pocket depth (PPD), clinical attachment level (CAL) and gingival recession (GR). Defects were randomly assigned to test or control group and the treatment consisted of a microsurgical access flap procedure designed for maximum tissue preservation. The exposed root surfaces of the test sites were conditioned with a 24% EDTA gel followed by EMD (Emdogain ) application whereas the control group was only treated by the microsurgical approach. Primary flap closure was achieved by a 2-layered suturing technique. Postoperative healing was evaluated by a newly introduced early wound-healing index (EHI) at 1 and 2 weeks after surgery. Both test and control groups showed a statistically significant mean CAL gain of 2.8 and 2.0mm at 6 months, and 3.6 and 1.7mm at 12 months, respectively (p≥0.05). Differences in CAL gain between the two treatment modalities were statistically significant at both time points. Additional GR values after 12 months averaged 0.3 and 0.4mm for test and control sites, respectively, and did not reach statistical significance. Two weeks after surgery, primary closure was maintained in 89% of the test sites and in 96% of the control sites. Both treatment modalities using the microsurgical flap procedure resulted in a high percentage of primary flap closure and maximum tissue preservation. In terms of PPD reduction and CAL gain, the combination with EMD application appeared to be superior to the microsurgical access flap alone.3
Cortellini P, Tonetti MS (2009) described a modified surgical approach of the minimally invasive surgical technique (modified minimally invasive surgical technique, M-MIST) and preliminarily evaluated its applicability and clinical performances in the treatment of isolated deep intrabony defects in combination with amelogenins. Twenty deep isolated intrabony defects in 20 patients were studied. Fifteen were surgically accessed with the M-MIST, while in five sites, which represented a lingual intrabony component, the conventional MIST had to be applied.The M-MIST consisted of a buccal incision of the defect-associated papilla, according to the principles of the papilla preservation techniques. Only a buccal flap was raised while the interdental papilla was left in situ. The granulation tissue filling the defect was dissected and removed, leaving the interdental and palatal tissues untouched. Root instrumentation and application of the regenerative material were performed before suturing. Primary closure of the flaps was attained with a single internal modified mattress suture. Surgery was performed with the aid of an operating microscope and microsurgical instruments. Early wound healing was uneventful: primary wound closure was attained and maintained in all sites. No oedema or haematoma was noted. Patients did not report pain or discomfort. The 1-year clinical attachment level (CAL) gain was 4.5 _ 1.4mm in defects 6 _ 1.5mm deep. Residual probing depths (PDs) were 3.1 _ 0.6 mm. A minimal increase of 0.1 _ 0.3mm in gingival recession between baseline and 1 year was observed. 4
Dahiya P, Kama R, Gupta R, Pandit N. (2011) compared root surface characteristics following root planing with various hand- and power-driven instruments.20 single, rooted teeth were used in this study; two specimens were used as control (no instrumentation done) and the remaining 18 specimens were equally divided into three groups. Specimens from each group were then subjected to root planing by one of the following instruments: (1) a Gracey curette, (2) ultrasonic tip and (3) a Rotary bur. In each case, the time required for scaling and root planing and surface roughness using the Roughness and Loss of Tooth Substance Index (RLTSI) was measured. The mean RLTSI scores for the Gracey curette, ultrasonic and rotary instrument groups were 2.5, 2.0 and 0.667, respectively. The mean scores of time spent for scaling and root planing by the Gracey curette, ultrasonic and rotary instrument groups in seconds were 42.50, 35.83 and 54.50, respectively. Hence, all the three instruments were found to be effective in mechanical debridement of the root surface, but rotary instruments were superior for root planing to achieve a smooth, clean root surface.5
3 / Objectives of the study:
1.  To assess and compare clinically the periodontal treatment outcomes in patients with periodontitis using open flap debridement approach by microsurgical and conventional surgical methods.
2.  To assess and compare the healing outcomes in both the approaches using histopathology.
3.  To assess and compare the root surface alterations in the teeth treated by both the methods using scanning electron microscopy.
7 / MATERIAL AND METHODS
7.1  Source of data:
Patients visiting the Department of Periodontics, Bangalore Institute of Dental Sciences and Hospital and Research centre,Bangalore.
7.2  Method of collection of data (including sampling procedures, if any)
CLINICAL STUDY
Following initial screening, 15 patients with localized or generalized periodontitis involving two or more than two quadrants will be selected. The selected patients will be randomly divided into two groups following the split mouth study design.
1 - Test group: to be treated by open flap procedure using microsurgical technique.
2- Control group: to be treated by open flap procedure using conventional surgical technique.
The following clinical parameters will be recorded at baseline(0), 1 month,3 months and 6 months following therapy,
1. Gingival index (Loe and Sillness).
2. Probing pocket depth.
3. Relative attachment level (using an acrylic stent)
In addition, soft tissue healing using primary flap closure assessment will be done at baseline(0),1 day, 2 days, 4 days , 8 days, 15 days, 1 month, 3 months and 6 months following therapy.
In the test site, open flap debridement using microsurgical technique will be performed using 2.5X optical magnification dental loupe. After reflecting the flap, the soft and hard tissue deposits will be removed using an ultrasonic scaler and Gracey curettes. Flap approximation will be done using 5-0 sutures.
In the control site, open flap debridement using conventional surgical technique will be carried out with flap closure to be done by 3-0 sutures.
THE IN VITRO STUDY
In a parallel study design, 5 patients in whom extraction is indicated in teeth in two or more quadrants owing to severe form of periodontitis will be selected. These will be randomly divided into 2 groups (test and control) before the extraction is done and the same procedure carried out in the clinical study following the spilt mouth design will be done .One week following this treatment, the concerned teeth will be extracted with a margin of healing soft granulation tissue around it and the following parameters will be assessed and compared.
a.  Presence of residual calculus and loss of tooth substance using Scanning Electron Microscopy.
b.  Contents of the healing soft tissue using histopathology.
The clinical parameters in the test and control group will be statistically analyzed by students‘t’ test using SPSS V12 software.
7.3  Inclusion Criteria:
1. Patients willing to sign on a written consent form.
2. Male and female patients aged between 25-55 years.
3. Patients with suprabony pockets with probing pocket depth ≥ 5mm in 1 or more teeth in two or more quadrants.
4. Number of teeth present ≥ 20.
7.4 Exclusion Criteria
1. Presence of any systemic or debilitating diseases.
2. Pregnant or Lactating women.
3. A recent history or presence of any acute or chronic infections.
4. Patients with history of any drug intake including antibiotics, analgesics or any other drugs three months prior to study.
5. Patients who have undergone periodontal therapy in the last six months.
6. Patients who are smokers/paan/tobacco/betelnut users.
7. Patients who are physically or mentally challenged.
7.5  Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly.
Yes. Following investigations will be done:
1.  Blood investigations
2.  Radiographic investigations
7.6  Has ethical clearance been obtained from your institution in case of 7.5?
Yes.
Ethical approval has been sought and obtained for the study from the institution.
8 / LIST OF REFERENCES:
8.1 Journal References:
1.Wikesjö UME, Crigger M, Nilveus R, Selvig KA, Early healing
events at the dentin-connective tissue interface. Light and transmission
electron microscopy observations. J Periodontol 1991; 62:5-14.
2.Schwarz JP, Guggenheim R, Düggelin M, Hefti AF, Rateitschak-Plüss EM, Rateitschak KH. The effectiveness of root debridement in open flap procedures by means of a comparison between hand instruments and diamond burs. A SEM study. J Clin Periodontol 1989 Sep;16(8):510-18.
3.Wachtel H, Schenk G, Bo¨hm S, Weng D, Zuhr O, Hu¨rzeler MB: Microsurgical access flap and enamel matrix derivative for the treatment of periodontal intrabony defects: a controlled clinical study. J Clin Periodontol 2003; 30: 496–504.
4.Cortellini P, Tonetti MS. Improved wound stability with a modified minimally invasive surgical technique in the regenerative treatment of isolated interdental intrabonydefects. J Clin Periodontol 2009; 36: 157–163.
5..Dahiya P, Kama R, Gupta R, Pandit N. Comparative evaluation of hand and power-driven instruments on root surface characteristics: A scanning electron microscopy study.J Indian Soc Periodontol 2011;2(2):79-83.
09 / Signature of the candidate
10 / Remarks of the Guide
11 / Name and designation of
Guide (In Block Letters)
11.1 Guide: / DR. SHREYA SHETTY,
PROFESSOR ,
DEPARTMENT OF PERIODONTICS,
BANGALORE INSTITUTE OF DENTAL SCIENCES AND HOSPITAL,
BANGALORE-560029.
11.2  Signature
11.3  Co-guide
11.4  Signature
11.5  Head of the Department / DR. APARNA RAHUL,
PROFESSOR AND HEAD,
DEPARTMENT OF PERIODONTICS,
BANGALORE INSTITUTE OF DENTAL SCIENCES AND HOSPITAL,
BANGALORE-560029.
11.6  Signature
12 / 12.1  Remarks of Chairman and Principal
12.2  Signature

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