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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA ANNEXURE – II PROFORMA FOR THE REGISTRATION OF SUBJECT FOR DISSERTATION BY DR. DIVYA KHANNA 1ST YEAR MDS DEPARTMENT OF PERIODONTOLOGY 2013 KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL BANGALORE- 562157 1 RAJIV GANDHI UNIVERSITY SCIENCES, KARNATAKA OF HEALTH Proforma for registration of subjects for dissertation 1. Name of the candidate and DR. DIVYA KHANNA Post Graduate Student, address: Department Of Periodontology, Krishnadevaraya College Of Dental Sciences, Krishnadevarayanagar, Hunasamaranahalli, Bengaluru – 562157 2. Name Of The Institution: Krishnadevaraya College Of Dental Science & Hospital. 3. Course of the study and Master of Dental Surgery Periodontology. subject: 4. Date of admission of the 5 June 2013 course 5. Title of the topic Pinhole Surgical Technique With And Without Use Of Button Application For Treatment Of Multiple Gingival Recessions: A Comparative Controlled Randomized Clinical Trial. 2 6 .BRIEF RESUME OF THE INTENDED WORK 6.1 NEED FOR STUDY Gingival recession is a term that designates the oral exposure of root surfaces due to displacement of the gingival margin apical to cementoenamel junction1, sequelae of which results in unfavourable esthetics, increased root caries susceptibility2 and dentin hypersensitivity3, hence periodontal therapy is indicated. Millers Class I and Class II recession defects mainly occur in multiple buccal areas and the main etiologic factors include trauma from tooth brushing, malposition of teeth, ectopic insertion of frenum and muscle attachment. Millers Class III and Class IV recessions usually involve the whole mouth and is often related to plaque associated chronic inflammatory periodontal disease.4 These recession defects involving many adjacent teeth were termed as multiple adjacent recession type defects (MARTD)5 or Multiple Recession Type Defects (MRTD).6 These terminologies have been used interchangeably in scientific literature. Complete root coverage of multiple recession type defects (MRTD) and an optimal integration of the associated tissues is an essential component of perioplastic surgery which is a demanding, continuously evolving and promising field. A variety of perioplastic procedures have been described to achieve soft tissue coverage of the exposed root surfaces in multiple adjacent recession type defect e.g.coronally advanced flap7(CAF), coronally advanced flap with Subepithelial Connective Tissue Graft8(SCTG), expanded mesh connective tissue graft with coronally advanced flap4, coronally advanced flap combined with orthodontic button application5, tunnel technique with subepithelial connective tissue graft9 and modifications10, vestibular incision subperiosteal tunnel access techique11, free gingival autograft12, periosteal pedicle graft13, rotated papilla autograft14 , semilunar repositioned flaps15 and Guided Tissue Regeneration (GTR).16,17 Treatment protocol and outcome of multiple adjacent recession type defects with different surgical procedures depends on many factors like recession defect size, presence or absence of keratinized tissue adjacent to the defect, width and height of interdental soft tissue, depth of vestibule, presence of frenum18, post operative stabilization and final position of advanced gingival margin.17 When MRTD are present, an approach to address all recession defects at one single surgical visit is the preferred choice3, coronally advanced flap alone and with various modifications have been used widely and successfully. But these techniques have certain limitations such as technique sensitivity, invasive, long procedural time is required, high morbidity and associated complications due to a second surgical site like post-operative pain, bleeding, swelling and long healing periods and this has led to the need for a newer minimally invasive, practical, short duration, single site surgery and patient centred approach in the management of MRTD. Pin hole surgical technique19 is one such novel technique which holds promise as a minimally invasive, predictable, efficient, time and cost-effective procedure for recession coverage in 3 MRTD. This procedure is based on only a single incision 2–3 mm for access in the alveolar mucosa at the base of recipient recession site , with no releasing incision, suturing and sharp dissections. The entire procedure can treat 3-10 recession defects with a single incision.19 Such newer techniques are here to stay and advance in perioplastic surgical procedures. However there are very few controlled clinical trials reporting this procedure and its comparison with other techniques of recession coverage in MRTD. The most important part of any perioplastic surgery for recession coverage is the anchorage and stabilization of the displaced flap during first two weeks of wound healing.5 Coronally advanced flap with button application for stabilization of sutures and coronal stabilization of advanced flap showed better results than coronally advanced flap alone in treatment of MRTD.5 Its been shown that the greater post operative displacement of gingival margin may cause greater root coverage.20,27 Hence the modification of pinhole surgical technique with orthodontic button application and suturing may show enhanced root coverage as compared to pinhole surgery alone. There is a need for more research to be carried out to analyze the success of pinhole surgical technique in management of multiple recession defects. Thus the aim of this randomized controlled trial is to compare and evaluate the efficiency of pinhole surgical technique with and without application of buttons and sutures in the management of MRTD. 6.2 REVIEW OF LITERATURE: Zucchelli and Sanctis (2000) conducted a case series study to evaluate root coverage with a new surgical approach to the coronally advanced flap procedure for treatment of multiple recession defects in patients with esthetic demands at 1 year examination. The results showed 88% complete root coverage and greater reductions in recession in cases with less amount of keratinized tissue apical to recession defect.18 Zucchelli et al. (2005) conducted a long term case series (5 years) for treatment of Multiple Adjacent Recession Defects (MRTD) using envelope type coronally advanced flap and the 5 year follow up showed, increased in keratinized tissue and 85% of treated recessions defects showed complete root coverage.25 Chambrone et al. (2009) conducted a systematic review of periodontal plastic surgery in the treatment of multiple recession type defects and concluded that the mean width of keratinized tissue increased significantly and mean root coverage achieved ranged from 94% - 98% and the need for more randomized controlled trials to identify the indication for each surgical technique.6 Pini Prato et al. (2010) conducted a split mouth randomized controlled study to evaluate coronally advanced flap versus connective tissue graft in the treatment of multiple gingival recessions with a 5 year follow up and concluded that 52% sites showed completed root 4 coverage when treated with coronally advanced flap and connective tissue graft in comparison to 35% coverage in coronally advanced flap treated sites.8 Zadeh (2011) conducted a case series to introduce a new minimally invasive treatment of multiple gingival recession defects in maxillary anterior region by vestibular incision subperiosteal tunnel access technique. The result showed good outcome in esthetic zones.11 Ozcelik et al. (2011) conducted a randomized controlled trial for treatment of multiple recession defects using coronally advanced flap combined with orthodontic button application and the result showed 84% complete root coverage and high patient satisfaction with esthetic demands.5 John Chao (2012) introduced a novel approach for treatment of multiple recession defects using a Pin Hole Surgical Technique and concluded that 94% mean defect reduction was obtained along with minimum post operative complications and optimal patient based outcome.19 6.3 OBJECTIVE OF STUDY The Primary objective of this study is to compare and evaluate the effectiveness and predictability of Pinhole surgical technique alone and its modification with orthodontic buttons and sutures in the treatment of multiple adjacent recession defects. The following primary outcomes will be assessed - the difference in Gingival recession width (GRW), Gingival recession depth (GRD), Complete root coverage (CRC) and root coverage esthetic score (RES). The secondary objectives of the study will be to assess the influence of these surgical procedures on the gingival and periodontal health. The secondary outcomes that will be assessed are difference in probing pocket depth (PD), relative attachment level (RAL) and width of keratinized tissue (KTW). 7. MATERIALS & METHODS 7.1 SOURCE OF DATA Patients referred to Department of Periodontology, Krishnadevraya College of Dental Sciences and Hospital and satisfying the inclusion and exclusion criteria will be selected for the study. 5 7.2 METHOD OF COLLECTION OF DATA Sample Size: The prospective study will be a single blind comparative controlled randomized clinical trial with 40-50 recession defects in each study group. Patients with atleast two or three18 teeth having Millers Class I, II or combination of class I and II recession defects19 in the maxillary arch will be selected. Inclusion Criteria: Multiple (atleast two or three) Millers class I and II or combined class I and II recession defects19 affecting adjacent teeth of the maxillary arch. Patients with thick gingival biotypes >0.8mm.24 Presence of adequate keratinized tissue apical to recession > 1mm.5 Age group 25-55 years.20 Patients with history of compliance to oral hygiene instructions and a full mouth plaque score of <10%. (O Leary 1972) Patients willing to participate in the study. American Society of Anaesthesiologists Physical Status I or II.19, 21 No contra-indications for periodontal surgery.19 Non-Smokers.22,23 Patients with esthetic concerns.25 Exclusion Criteria: Recession defects associated with caries/demineralization, restorations, and deep abrasions (step >2mm).5 No occlusal interferences.5 Teeth with evidence of pulpal pathology.5 Patients who have undergone any previous periodontal surgical procedures at the involved sites.19 Pregnant and lactating women. Patients on medications known to interfere with periodontal tissue health or healing.29 6 SAMPLING TECHNIQUE 1. The patients will be assigned into two treatment groups (test and control). The test group will be treated with pinhole surgical technique using buttons and sutures for flap advancement and stabilization, the control group will be treated by pinhole surgery alone. 2. After screening examination in the initial phase, each subject will receive a session of oral hygiene instructions, scaling and root planing with ultrasonic scalers and manual curettes. 3. A coronally directed roll technique for brushing will be prescribed for teeth with recession defects to minimize the tooth brushing trauma to the gingival margin.29 4. Surgical treatment of the recession defects will not be scheduled until the patient can demonstrate an adequate standard of supragingival plaque control (plaque score <10% O Leary 1972). The below mentioned clinical parameters will be recorded to the nearest millimeter using a UNC-15-probe5 (University of North Carolina -15 periodontal probe – Hu Friedy, Chicago, IL, USA.) and measuring occlusal stents for positioning measuring probes will be fabricated with cold-cured acrylic resin on a cast model obtained from an alginate impression. It will be produced so that it covers the occlusal surfaces of the tooth being treated and the occlusal surfaces of atleast one tooth in the mesial and distal directions. It will also be extended apically on the buccal and lingual surfaces to cover the coronal third of the teeth. Three grooves will be marked on the stent at mesio-buccal, mid-buccal and disto-buccal sites as standardized reference points26 so that post surgical measurements will be made at the same position and angulation as those made before surgery. Measurements will be recorded before surgery ie. baseline measurements then after 6 weeks, 3 months and 6 months. All measurements will be carried out by a single masked examiner. Prior to the study, the examiner will be calibrated to reduce intra examiner error (kappa >0.75) and to establish reliability and consistency.29 Clinical Measurements The following clinical measurements will be recorded at baseline, 6weeks, 3months and 6months. 1. Gingival Recession Depth (GRD), measured as the distance between the most apical margin of occlusal stent and the gingival margin.5 2. Gingival Recession Width (GRW), measured as the distance between the mesial gingival margin and distal gingival margin (measurement will be recorded on a horizontal line tangential to the cementoenamel junction).5 3. Probing Depth (PD), measured as the distance from the gingival margin to the base of gingival sulcus.19 4. Relative Attachment Level (RAL), measured as the distance from the apical border of the occlusal stent to the base of the gingival sulcus.19 7 5. Apico-coronal width of keratinized tissue (KTW) measured as the distance from the mucogingival junction to the gingival margin ,with the mucogingival junction location determined using a visual method (Schiller’s Potassium Iodide Solution).5 6. Location of Gingival margin after suturing with respect to occlusal stent is calculated by subtracting the distance between stent margin and gingival margin from the distance between stent margin and gingival margin after suturing.27 7. Plaque Index -Silness and Loe 1964. 8. Gingival Bleeding Index –Ainamo and Bay 1975. 9. Gingival Index – Loe and Silness 1963. 1. 2. 3. 4. The following parameters will be included with the above mentioned measurements during recall at 6 weeks, 3 months and 6 months. Recession depth reduction.5 Mean root coverage.5 Complete Root Coverage.5 Esthetic evaluations according to Root Coverage Esthetic Score System.28 SURGICAL PROCEDURE: Before starting the surgery, root surfaces near to buccal attachment loss will be instrumented with mini-five Gracey curettes and the mechanical treatment will be terminated when smooth and hard root surfaces will be obtained.5,29 Under injection of local anaesthesia 2% lignocaine hydrochloride (Lignox 2%, Indoco Remedies Ltd, Goa, India.) using a No. 15 scalpel (Bard Parker), a minimum horizontal incision of 2-3 mm will be made in the alveolar mucosa near the base of vestibule, apical to recipient sites.19 Papilla elevator (TKN2, Hu Friedy, Chicago, IL, USA.) will be inserted through the entry incision and a full thickness mucoperiosteal flap will be elevated.19 Elevation of flap will be guided by visualization of the shape and movement of instrument through mucosa and gingival tissue.19 Flap reflection will then be extended coronally and horizontally to allow for elevation of two adjacent papillae on each side of denuded roots. The interproximal extension of flap will result in a freely movable flap, which will be then positioned coronally to extend beyond cementoenamel junction (CEJ). For flap stabilization, a malleable bioresorbable collagen membrane11 (HealiguideTM, EnColl Corp. USA) will be used (2x12mm strips pre-soaked in sterile water) and tucked with curved tissue forceps into sub-gingival spaces under the papillae and marginal soft tissue (actual number of strips used will depend on the amount of material needed to secure the flap in desired position).19 Tissue tension created by distension or pouching of the flap will hold the graft strips in place (without sutures or tissue adhesives). Gentle digital pressure will be applied for 5 minutes approximately.15,19 8 The incision will be left to heal by primary intention without suturing. However in the Test group, before starting the surgery, orthodontic buttons (Prime orthodontics, Inc. Portland, USA) will be applied on the middle of middle one third of the crown of tooth with dental cement (dual cure glass ionomer cement 3M ESPE, USA) and cured with light until hardened.5 Surgical procedure of flap reflection will be identical to control group and flap will be maintained in a coronally position by suspended sutures around the orthodontic buttons on teeth and around teeth. The sling sutures with 5-0 ( non absorbable surgical sutures, Mersilk, Ethicon, Johnson & Johnson, Himachal Pradesh, India.) will be used to suspend the central area of the flaps on the buttons. These sling sutures will allow for the most coronal positioning of the flaps. The second sutures with 6-0 (non absorbable surgical sutures, Mersilk, Ethicon, Johnson & Johnson, Himachal Pradesh, India.) will be performed to accomplish a precise adaptation of the buccal flap on the convexity of the underlying crown surface and permitted the stabilization of every surgical papilla.5 At the end of surgery, the flap margins will be at least 3-4mm coronal to CEJ of all teeth. Periodontal dressing (Coe Pack – non eugenol periodontal dressing, GC America Inc. ALSIP, IL, USA.) will be applied to avoid any mechanical trauma.5 Post-operative instructions will consist of 0.12% chlorhexidine gluconate mouth rinse 3 times daily for 1 minute and avoidance of brushing at surgical site for 6 weeks19 will be advised to the patient. Post operative pain and edema will be controlled with non steroidal anti inflammatory drug (Tab Ibuprofen 400mg thrice daily for three days) and antibiotic (Cap Amoxicillin 500 mg thrice daily for seven days), if patient is allergic to pencillins (Cap Clindamycin 300 mg four times daily for seven days) after meals will be prescribed. Patients will be advised to consume only soft and warm food during the first week.5 The sutures, orthodontic buttons and periodontal dressing will be removed 14 days after surgery. After this period, patients will be reinstructed in mechanical cleaning of the treated teeth and use of a soft toothbrush and roll technique of brushing for 1 month.29 Patient will be recalled for reinforcement of oral hygiene instructions and light debridement with ultrasonic scalers supragingivally will be carried out. Clinical parameters will be recorded at 6 weeks, 3 months, 6 months after surgical reconstruction. Statistical Analysis For each continuous variable, normality will be checked by Kolmogorov – Smirnov and Shapiro – Wilk tests and by histograms. Comparison between independent groups will be done by using the student t - test or Mann – Whitney U test. Data between the time dependent groups will be analysed by paired t - test or Wilcoxons rank sum test. The categorical variables between the groups will be analysed by using the x2 – test. 9 7.3 Does the study require any investigation or intervention to be done on humans or animals? Yes. The study requires a pin hole surgical approach on the control site and an additional application of orthodontic buttons and sutures on the test site in humans. 7.4 Has the ethical clearance been obtained from your institution in the case above? Yes. A copy of the same has been enclosed. 10 LIST OF REFERENCES: 1) Periodontology. AAo. Glossary of Periodontal Terms. ed4: American Academy of Periodontology 2001. 2) Lawrence HP, Hunt RJ, Beck JP. Three Year root caries incidence and risk modelling in older adults in North Carolina. J Public Health Dentistry 1995;55: 69-78. 3) Carvalho P, Da.Silva RC, Cury P. Modified coronally advanced flap associated with a subepithelial connective tissue graft for treatment of adjacent multiple recessions. J Periodontol 2006;77:1901-06. 4) Cetiner D, Bodur A, Uraz A. Expanded mesh connective tissue graft for the treatment of multiple gingival recessions. J Peridontol 2004;75:1167-1172 5) Ozcelik O, Haytac MC, Seydaoglu G. Treatment of multiple gingival recession using a coronally advanced flap procedure combined with button application. J Clin Periodontol 2011;38:572-80. 6) Chambrone L, Lima LA, Pustiglione FE, Chambrone LA. Systematic review of perioplastic surgery in the treatment of multiple recessions type defects. JCDA 2009;75:203(a) 203(f). 7) Bernimoulin P, Luscher B, Muhlemann HR. Coronally repositioned periodontal flap:Clinical evaluation after one year. J Periodontol 1975;2:1-13. 8) Pini Prato GP, Cairo F, Nieri M, Franceschi D, Rotundo R, Cortellini P. Coronally advanced flap versus connective tissue graft in treatment of multiple gingival recessions: a split mouth study with 5year follow up. J Periodontol 2010;37:644-650. 9) Zabalegui I, Sicilia A, Cambra J, Gil J. Treatment of multiple adjacent gingival recessions with tunnel subepithelial connective tissue graft: A clinical report. Int J Periodontics Restorative Dent 1999;19:199-206. 10) Tozum TF, Dini FM. Treatment of adjacent gingival recessions with subepithelial connective tissue graft and modified tunnel technique. Quintessence International 2003;34:7-13. 11) Zadeh HH. Minimally invasive treatment of maxillary anterior gingival recession defects by vestibular incision subperiosteal tunnel access and platelet derived growth factor BB. Int J Periodontics Restotative Dent 2011;31:653-660. 12) Livingston HL. Total coverage of multiple and adjacent denuded root surfaces with a free gingival autograft: A case report. J Periodontol 1975;46:209-216. 13) Mahajan A. Treatment of multiple gingival recession defects using periosteal pedicle graft: A case series. J Periodontol 2010;81:1426-1431. 14) Tinti C, Benfenati SP. The free rotated papilla autograft: A new bilaminar grafting procedure for the coverage of multiple shallow gingival recessions. J Periodontol 1996;67:1016-1024. 11 15) Tarnow DP. Semilunar 1986;13:182-185 coronally repositioned flap. J Clin Periodontol 16) Rotundo R, Nieri M, Mori M, Clauser C, Prato G. Aesthetic perception after root coverage procedure. J Clin Periodontol 2008;35:705-712. 17) Pini-Prato G, Clauser C, Magnani C, Cortellini P. Resorbable membrane in the treatment of human buccal recession: 9 case report. Int J Periodontics Restorative Dent 2005;15:258-67. 18) Zucchelli G and Sanctis M. Treatment of multiple adjacent recession defects in patients with esthetic demands. J Periodontol 2000;71:1506-1514. 19) Chao J. A novel approach to root coverage: Pinhole surgical technique. Int J Periodontics Restorative Dent 2012;32:521-531. 20) PiniPrato G, Baldi C, Pagliaro U, Nieri M, Rotundo R, Cortellini P. Coronally advanced flap procedure for root coverage. Treatment of root surfaces: Root planning versus polishing. J Periodontol 1999;70:1064-1076. 21) Maloney WJ, Weinberg MA. Implementation of American society of anesthesiologists physical status classification system in periodontal practice. J Periodontol 2008;79:1124-1126. 22) Trombelli L, Scabbia A. Healing response of gingival recession defects following guided tissue regeneration procedures in smokers and non smokers. J Clin Periodontol 1997;24:529-533. 23) Chambrone L, Chambrone D, Pustiglioni FE, Chambrone LA, Limo LA. Influence of tobacco smoking on the outcome achieved by root coverage procedures:A systematic review. JADA 2009;140:294-306. 24) Baldi C, PiniPrato G, Pagliaro U, Nieri M, Saletta D, Muzzi L, Cortellini P. Coronally advanced flap procedure for root coverage : A 19 case series. J Periodontol 1999;70:1077-1084. 25) Zucchelli G, De Sanctis M. Long term outcome following treatment of multiple Miller Class I and II recession defects in esthetic ares of mouth. J Periodontol 2005;76:2286-2292 26) Huang LH, Neiva REF, Wang HL. Factors affecting the outcomes of coronally advanced flap root coverage procedures. J Periodontol 2005;76:1729-1734 . 27) Pini-Prato G, Baldi C, Nieri M, Franseschi D, Cortellini P, Clauser C, Rotundo R, Muzzi L. Coronally advanced flap: post surgical position of gingival margin is an important factor for achieving complete root coverage. J Periodontol 2005;76,713722. 12 28) Cairo F, Rotund R, Miller PD Jr., PiniPrato G. Root coverage esthetic score: a system to evaluate the esthetic outcome of treatment of gingival recession through evaluation of clinical cases. J Periodontol 2009;80:705-710 29) Zucchelli G, Mele M, Mazzotti C, Marzadori M, Montebugnoli L, De Sanctis M. Coronally advanced flap with and without vertical releasing incisions for the treatment of multiple gingival recessions: A comparative controlled randomized clinical trial. J Periodontol 2009;80:1083-1094. 30) Hwang D, Wang HL. Flap thickness as a predictor of root coverage: A systematic review. J Periodontol 2006;77:1625-1634. 13 09. Signature of the candidate 10. Remarks of the guide 11. Name and designation 11.1 Guide Dr. JOANN PAULINE GEORGE PROFESSOR 11.2 Signature 11.3 Co Guide ---11.4 Signature 11.5 Head of the Department Dr. PRABHUJI MLV PROFESSOR 11.6 Signature 12.1 Remarks of the Principal 12.2 Signature 14 KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES HOSPITAL HUNASAMARANAHALLI, BANGALORE-562157 AND Ethical clearance for dissertation study “ PINHOLE SURGICAL TECHNIQUE WITH AND WITHOUT USE OF BUTTON APPLICATION FOR TREATMENT OF MULTIPLE GINGIVAL RECESSIONS : A COMPARATIVE CONTROLLED RANDOMIZED CLINICAL TRIAL” by Dr. DIVYA KHANNA, postgraduate student in the Department of Periodontics, Krishnadevaraya College of Dental Sciences and Hospital, under Rajiv Gandhi University of Health Sciences, Karnataka. Ethical committee meeting was held on November 5th 2013 in the Boardroom of Krishnadevaraya College of Dental Sciences & Hospital. The Members discussed all the ethical issues involved 1. Review of literature and remarks of previous studies. 2. Risks and expected beneficial effects. 3. Cost factor. 4. Supervision by Senior Staff members. 5. ICMR guidelines for Research studies. The members were satisfied regarding all the above Ethical issues concerned and ethical clearance was granted for the Dissertation Study. ETHICAL COMMITTEE MEMBERS SN NAME AND DESIGNATION POSITION 1 Dr. H. Nandakumar, Principal & HOD, Dept. of Chairman SIGNATURE Oral & Maxillofacial Surgery 2 Dr. Sharath Chandra, Prof & HOD, Dept. of Co- Chairman Conservative Dentistry 3 Mr. Gundu Rao, NGO, Social Activist Member 4 Mr. Mohumed Sadiqh B.A, Advocate Member 5 Dr. Vijay Mohan Reddy.N.H, Administrative Member Medical Officer, Government General Hospital, Yelahanka 15 6 7 Dr. Srinivasa. G.N, Physician, Government General Hospital Dr. Nikhilananda Hegde, HOD, Orthodontics Member 8 Dr. Prabhuji MLV, HOD, Periodontics Member 9 Dr. ShivaShankar, Prof. & HOD, Prosthodontics Member 10 Dr. M.B.Radhika, Prof.& HOD, Oral Pathology Member 11 Dr. Murali.R, Professor & HOD, Public health Member dentistry 12 Dr. Deepak Vishwanath, Professor & HOD, Member Pedodontics 13 Dr. Vijeev Vasudevan, Professor& HOD, Oral Medicine Member 14 Dr. N. Srinath, Professor, Oral Surgery Member 15 Dr. H.S.Prabhakar, Anesthetist, KHRC Member 16 CONSENT FORM I, ……………….. aged…………. yrs, son/daughter/wife /husband of ………………….. here by authorize Dr. DIVYA KHANNA, working at KCDS & HOSPITAL, to perform any diagnostic examination and surgical procedure under local anaesthesia. The nature of the condition and any possible complications of the procedure have been explained to me in the language I understand by my surgeon in presence of …………………………………… (witness). I also agree that if any untoward incident happens, which is beyond the surgeon’s control, no responsibility will be attached to the surgeon(s)/hospital/ staff. I also agree and give my full consent to participate in the study conducted in Department of Periodontology, KCDS & Hospital, and the nature of the study having been explained to me by my surgeon (s). I declare that I am of sound mind and I am giving this consent with my own decision & willingness and not under any compulsion or pressure by any of the hospital staff/doctors, after having read and understood the contents of the consent form. Name of the procedure: PINHOLE SURGICAL TECHNIQUE WITH AND WITHOUT USE OF BUTTON APPLICATION FOR TREATMENT OF MULTIPLE ADJACENT RECESSIONS : A COMPARATIVE CONTROLLED RANDOMIZED CLINICAL TRIAL. Signature of the patient/person giving consent WITNESS SIGNATURE 1. 2. 17 ANNEXURE-Ị GINGIVAL INDEX (Loe and Silness, 1963) Method: The severity of gingivitis is scored on the mesiofacial and distofacial papillae, facial and lingual margin of selected teeth. A blunt instrument is used to assess the bleeding potential of tissues The index relies entirely on visual criteria of gingivitis and eliminates the use of probing or pressure to establish the presence or absence of bleeding. Scoring criteria: SCORE CRITERIA 0 Absence of inflammation/normal gingiva. 1 Mild inflammation, slight change in color, slight edema; no bleeding on probing 2 Moderate inflammation; moderate glazing, redness, edema and hypertrophy. Bleeding on probing. 3 Severe inflammation; marked redness, hypertrophy and ulceration. Tendency to spontaneous bleeding G.I SCORE = Total score No. of teeth examined Rating Score Mild gingivitis Moderate gingivitis Severe gingivitis 0.1 - 1.0 1.1 - 2.0 2.1 - 3.0 18 ANNEXURE-II PLAQUE INDEX (Sillness T and Loe H, 1964) Method: The scoring is done on the entire dentition or on selected teeth. Plaque of the cervical third of the tooth is evaluated with no attention to plaque that has extended to the middle or incisal thirds. The surfaces examined are the four gingival areas of the tooth i,e the disto-facial, facial, mesio-facial, and lingual surfaces. A mouth mirror, a light source, dental explorer, and air drying of the teeth and gingiva are used. Scoring criteria: SCORE CRITERIA 0 No plaque 1 A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be in situ only after application of disclosing solution or by using probe on the tooth surface. 2 Moderate accumulation of soft deposit within the gingival pocket, or the tooth and the gingival margin which can be seen with naked eye. 3 Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. P.I SCORE= Total score No. of teeth examined Rating Excellent Good Fair Poor Score 0 0.1 – 0.9 1.0 – 1.9 2.0 – 3.0 19 ANNEXURE-III GINIVAL BLEEDING INDEX (Ainamo J and Bay I, 1975) The gingival bleeding index of Ainamo J and Bay I was developed as an easy and suitable way for assessing a patient’s progress in Plaque control. The presence or absence of gingival bleeding is determined by gentle probing of the gingival crevice with a periodontal probe. The appearance of bleeding within 10 seconds indicates a positive score, which is expressed as percentage of the total number of gingival margin examined. Scoring criteria: SCORE CRITERIA 0 No bleeding present on probing within 10 seconds. 1 Bleeding present on probing within 10 seconds. Calculation: Total score No. of teeth examined 20 ANNEXURE-IV ROOT COVERAGE ESTHETIC SCORE SYSTEM (Cario et al. 2009) The Aesthetic evaluation was performed according to the root coverage aesthetic score system (RES).28 5 Variable evaluated which are as follows: a. b. c. d. e. Gingival margin position (GM) Marginal Tissue Contour (MTC) Soft Tissue Texture (STT) MGJ alignment Gingival Colour (GC) Gingival Marginal Position/Level (GM) SCORE 0 3 6 CRITERIA Failure of Root Coverage Partial Root Coverage Complete Root Coverage Marginal Tissue Contour (MTC) SCORE CRITERIA 0 Irregular gingival margin (doesn’t follow the CEJ) 1 Proper contour/scalloped gingival margin (follows the CEJ) Soft Tissue Texture (STT) SCORE 0 1 CRITERIA Scar formation and/or keloid-like appearance Absence of scar or keloid formation 21 Mucogingival junction alignment (MGJ) SCORE 0 1 CRITERIA MGJ not aligned with the MGJ of adjacent teeth MGJ aligned with the MGJ of adjacent teeth Gingival Colour (GC) SCORE 0 1 CRITERIA Colour of tissue varies from gingival colour at adjacent teeth Normal colour integration with the adjacent soft tissues Ideal Aesthetic Score = 10 0 Point Assigned If: a. Final position of the GM was equal or apical to the previous recession depth (failure of root-coverage procedure) irrespective of colour, the presence of a scar, MTC or MGJ. b. Partial or total loss of inter-proximal papilla (black triangle) occurred following the treatment. 22