DISSERTATION – SYNOPSIS DR. JENCY SAMUEL JOHNSON POST GRADUATE STUDENT DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY K.V.G. DENTAL COLLEGE & HOSPITAL KURUNJIBAGH, SULLIA – 574327 DAKSHINA KANNADA BATCH OF 2012 – 2015 RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA, BANGALORE ANNEXURE-II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION 1. NAME OF THE CANDIDATE DR. JENCY SAMUEL JOHNSON AND ADDRESS POST GRADUATE STUDENT ( IN BLOCK LETTERS) DEPT OF PEDODONTICS AND PREVENTIVE DENTISTRY KVG DENTAL COLLEGE AND HOSPITAL, SULLIA, KARNATAKA 2. KVG DENTAL COLLEGE AND HOSPITAL, NAME OF THE INSTITUTION SULLIA, KARNATAKA 3. COURSE OF STUDY AND MASTER OF DENTAL SURGERY (M.D.S) IN PEDODONTICS SUBJECT AND PREVENTIVE DENTISTRY 4. DATE OF ADMISSION TO 30-05-2012 COURSE A COMPARATIVE EVALUATION OF THE 5. TITLE OF THE TOPIC DENTOSKELETAL TREATMENT EFFECTS OF MYOFUNCTIONAL TRAINERS AND TWIN BLOCK APPLIANCES ON CLASS II DIVISION I MALOCCLUSIONS 6 BRIEF RESUME OF THE INTENDED WORK: 6.1) Need For The Study: Most of the severe skeletal irregularities in sagittal, transversal and vertical direction that require complicated and expensive orthodontic-surgical procedures in adolescence could be prevented in early stage.1 In Class II Division I malocclusions, the mandible is locked in distal position by an unfavorable distal driving occlusion that do not favor mandibular development to the patients’ full potential of growth.2 To initiate Class II orthopaedic therapy at an earlier age, correction of functional problems of soft tissues such as lingual malposition, the centripetal thrust of the lips and cheeks and oral respiration need to be the part of the goal.3 Amongst the various appliances used for correction of Class II Division I malocclusions, conventional twin block appliances and novel pre fabricated preorthodontic trainers has gained immense popularity. However, very little has been reported in the scientific literature, with regard to the direct comparisons of the efficacies of the two treatment modalities. Twin block appliances induce supplementary lengthening of mandible by stimulating increased growth at the condylar cartilage when constructed to a protrusive bite with occlusal inclined plane as guiding mechanism and closes the mandible forward. Thus, correction of class 2 malocclusion in mandibular deficiency cases can be done by utilizing the pubertal growth spurts.2,4 Trainer System appliances exercise craniofacial system muscles to physiological load of bones and stimulate growth and development of all craniofacial system structures.5 Leading the facial and masticatory muscles to work properly, balancing the forces of the tongue and cheeks by proper tongue positioning in function and at rest, myofunctional trainers stimulate growth and development of maxilla, mandible and dental arches including correct teeth positioning .6 Some authors demonstrated that functional appliances produce significant influence on mandibular growth, the others claimed that it may induce only small skeletal changes and significant dentoalveolar changes.7 Therefore the need of the present study is to analyze the skeletal and dentoalveolar changes in Class II Division I malocclusion cases treated with myofunctional trainers and twin block appliances and compare those alterations experienced with an untreated age and sex matched control group. 6.2) AIM OF THE PRESENT STUDY : a) To evaluate the maxillo-mandibular skeletal and dentoalveolar changes produced by prefabricated preorthodontic trainer on skeletal class II division I patients. b) To evaluate the maxillo-mandibular skeletal and dentoalveolar changes produced by twin block on skeletal class II division I patients. c) To compare the post treatment effects of myofunctional trainers and twin block appliances on skeletal and dentoalveolar components of Class II division I malocclusions. 6.3) REVIEW OF LITERATURE: A prospective control study investigated the net effects of the twin block appliance taking into account the effects of normal growth in an untreated control group. The treatment group consisted of 36 subjects (11boys, 17girls) of mean age 12.4years treated for 0.9years. Each subject had pre and post treatment lateral cephalograms taken. The control group consisted of 27 subjects of mean age 12.1years. In the treatment group a reduction in ANB of 2° was observed largely because of an increase in SNB of 1.9°. The overjet was reduced by combination of a net maxillary incisor retroclination of 10.8°, net mandibular incisor proclination of 7.9° and forward movement of the mandible. This study highlighted that twin block appliance is a very effective tool with which skeletal and dentoalveolar change can be obtained.8 A clinical study was done to investigate the treatment effects of a twin block appliance using Pretreatment and posttreatment cephalometric records of 28 consecutively treated patients (19male, 17 female) of mean age 9years and 1month with Class II malocclusion and compared it with an age and sex matched sample of untreated Class II control subjects(13male, 14female).The treatment group was treated using the twin block appliance.Results indicated that mandibular growth in the treatment group was on average 4.2mm greater than in the control group over the 14 month treatment period. In addition, some dentoalveolar effects in both arches contributed to the overjet correction. In general, the magnitude and direction of skeletal changes observed with the appliance were found to be quite favourable9. A case control study was done with the Twin-block appliance on 30 consecutive patients(14male, 16female of average age 12years, 6 months) with Class II Division 1 malocclusions. A control group was generated from published normative data such that each treated case was matched individually for age, sex, and treatment time. The cephalometric change during treatment was compared to the natural growth change in the matched control group. There was a statistically and clinically significant reduction in overjet, angle ANB, increase in angle SNB, and mandibular length together with a reduction in upper incisor angle. Thus concluding twin block to be effective in treating both dentoalveolar and skeletal discrepencies in class II division 1 maloccusion10. A study was done to clarify the dentoskeletal treatment effects induced by a preorthodontic trainer appliance treatment on Class II division I cases. Twenty Caucasian patients (10 boys and 10 girls, Mean age: 9.6 ± 1.3 years) with Class II division I malocclusion were treated with preorthodontic trainer appliances. A control group of 20 patients (10 boys and 10 girls, Mean age: 10.2 ± 0.8 years) with untreated Class II division I malocclusions was used to eliminate possible growth effects. Lateral cephalograms were taken at the start and end of treatment. At the end of the study period, the trainer group subjects showed significant changes including anterior rotation and sagittal growth of the mandible, increased SNB and facial height, reduced ANB, increased lower incisor proclination, retroclination of upper incisors, and overjet reduction, concluding that, the pre orthodontic trainer application induces skeletal and dentoalveolar changes.3 A study was done to analyze the skeletal and dentoalveolar changes in 34 Class II Division 1 malocclusion cases (15boys, 19 girls of mean age 10years and 2months) treated with Twin-block appliance by carrying out cephalometric evaluation before and after treatment. Mandibular length increased by 4.6 mm in the Twin-block group compared with 2.2 mm in the control group. ANB angle reduced by 2.3°, overjet reduction was 4.7 mm, postnormal molar position corrected by 3.6 mm. Twin-block appliance statistically significantly increased mandibular length by 2.4 mm during 12month treatment period. Thus concluding the efficiency of Twin-block treatment in achieving skeletal and dentoalveolar corrections by about 40% and 60% respectively.7 A study was done to evaluate the effect of Trainer positioners - T4K on three cephalometric variables. Thirty-four children, aged between 7 and 10 years, were selected for the purpose for over twelve months, and radiographs were obtained, one at the beginning and the other end of treatment. The variables: Co – A, Co – Gn and ANS – Me, were made on cephalograms and the magnitudes were compared among the tested group and control. The magnitudes were statistically validated and found to be significant. It was concluded that the use of the device has no effect on the growth restriction of the jaw, but it seems cause the increase of the effective growth of the jaw and the vertical dimension.11 A study comprising of 50 Class II Division I patients (20 test patients and 30 untreated controls) of age group 8 – 12 years was done to evaluate cephalometrically the treatment effects of preorthodontic trainer on dentoskeletal components in individuals showing Class II Division I malocclusion. Standardized lateral cephalograms of both groups were taken before and after the treatment period of 15months. The readings were tabulated and subjected to statistical analysis. The results showed significant reduction in overjet, increase in inclination of the mandibular incisors and vertical dimension of the face, showing significant reduction in skeletal Class II relationship. An upward cant of the occlusal plane in the treatment group was noted probably due to forward rotation of mandible. The results concluded that Class II corrections can be achieved with the pre orthodontic trainer appliance, which appears to have mostly dentoalveolar effects with smaller but significant skeletal effects.12 6.4 OBJECTIVES OF THE STUDY: a) To evaluate the effectiveness of pre fabricated orthodontic trainer by comparing the skeletal and dentoalveolar changes in a group of myofunctional orthodontic trainer treated Class II division I patients after active phase of treatment and untreated age and gender matched control group. b) To evaluate the effectiveness of twin block appliance by comparing the skeletal and dentoalveolar changes in a group of twin block treated Class II division I patients after active phase of treatment and untreated age and gender matched control group. c) To compare the post treatment cephalometric changes seen with prefabricated orthodontic trainer and twin block appliance on Class II division I malocclusions. 7 MATERIALS AND METHODS: 7. 1) Source Of The Data: Pre and post treatment clinical photographs, study casts, and cephalometric radiographs of 20 children (boys and girls) of age group of 8-14 yrs having Class II Division I malocclusion who were already treated and those diagnosed and consenting to treatment for study purpose with prefabricated orthodontic trainer (10 cases each) and twin block (10 cases each) will be procured from the records of Department of Pedodontics and Preventive Dentistry and Department of Orthodontics and Dentofacial Orthopaedics of KVG Dental College and Hospital, Sullia and centres treating similar cases in and around South Kanara District, Karnataka. 10 untreated Class 2 Division I age and gender matched controls not willing for removable orthodontic appliance therapy and who meet inclusion criterion will be chosen randomly for study purpose. Written informed consent will be taken prior to the study from their parents. INCLUSION CRITERIA: Study Group: 1. Class II skeletal malocclusion with orthognathic maxilla and retrognathic mandible 2. Class II Division I dental type malocclusion 3. Age group: 8-14 years (boys and girls of Indian descent) 4. Positive VTO 5. ANB angle: ≥ 30 6. Average to horizontal growth pattern 7. Over jet: ≥ 4.5mm with protrusion of maxillary central incisors 8. Occlusion criteria: Mixed dentition and early permanent dentition 9. Informed consent from parents Control Group : 1. Untreated age and gender matched Class II division I patients not willing for removable orthodontic appliance therapy. (The subjects in the control group will only be included in the study after obtaining written informed consent when they refuse orthodontic treatment.) EXCLUSION CRITERIA: 1. Medically compromised patients 2. Cases with congenital syndromes 3. Cases with obvious asymmetry 4. Patients with history of previous orthodontic treatment or surgical correction of maxilla-mandibular relationships. 5. Patients with history of thumbsucking habits 6. Patients with severe nasal obstruction 7. Patients with improper compliance or discontinued use of appliance during the tenure of the study. 7.2) Method Of Collecting Data : Cephalometric radiographs of 20 children (boys and girls) of age group of 8-14 yrs having Class II Division I patients who were treated and those diagnosed and consenting for treatment with prefabricated orthodontic trainer (10 cases each) and twin block (10 cases each) will be procured from the records of Department of Pedodontics and Preventive Dentistry and Department of Orthodontics of KVG Dental College and Hospital, Sullia and centres treating similar cases in and around South Kanara District, Karnataka. 10 untreated Class 2 Division I age and gender matched controls who meet inclusion criterion will be chosen randomly for study purpose. Written informed consent will be taken prior to the study from their parents. 1. Instruments and materials that will be used during the study: 1. Standardized lateral cephalograph films 2. Maxillary and mandibular dentulous metallic stock impression trays 3. Irreversible hydrocolloid Alginate impression material 4. ADA Type III dental stone 2. Methodology: 30 subjects (15 boys and 15 girls) in the age groups 8 – 14 years will be selected and divided into three groups. GROUP I – 10 Class II Division I patients (5 boys , 5girls) treated with prefabricated orthodontic trainer GROUP II – 10 Class II Division I patients (5 boys , 5girls) treated with twin block appliances GROUP III – 10 untreated Class II division I (5 boys, 5girls) control group. Detailed Case history of each subject who meets the inclusion criterion of the specific groups will be obtained after explaining the procedure and after obtaining consent. Alginate impressions of maxillary and mandibular teeth will be made for each subjects using metallic stock trays and poured in type III dental stone. The lateral cephalograms will be obtained at the start and end of the treatment. The final cephalograms of all the patients in control and experimental group will be taken at the end of 8-12 months period of the study. All cephalometric radiographs will be traced on matte acetate tracing paper in a random order by a single investigator using 3HB pencil inorder to reduce bias. 3. Collection of data: 28 landmarks will be identified on each lateral cephalogram and grouped as follows: S. NO ANGULAR SKELETAL LINEAR SKELETAL DENTAL MEASUREMENTS MEASUREMENTS MEASUREMENTS 1 SNA ( ) N – Me U1 – NA(mm) 2 SNB (0) S – Go U1 – NA (0) 3 ANB (0) Go – Ar U1 – SN (0) 4 NA – Pog (0) Co – Gn L1 – NB (mm) 5 SN – GoGn ( ) Go – Me L1 – NB (0) 6 N – S – Ar (0) IMPA (0) 7 S – Ar – Go (0) Inter – incisal angle 8 Ar – Go – Me (0) Overjet (mm) 9 FH – MP ( ) Overbite (mm) 10 PP – MP (0) Maxillary 0 0 0 molar position 11 OP – SN (0) Mandibular position 12 Me – Go – S (0) molar PLANES AND ANGLES: 1. Angle SNA: To determine whether maxilla is positioned anterior or posterior to cranial base. 2. Angle SNB: To determine whether mandible is anterior or posterior to cranial base 3. Angle ANB: To determine the relative position of jaws to each other. 4. Angle NA – Pog (Angle of Convexity): Measures the degree of maxillary basal arch at its anterior limit (point A) relative to total facial profile (Nasion – Pogonion). 5. Angle SN – GoGn (Mandibular plane angle): Measures the relation of the mandibular plane to anterior cranial base indicating the growth pattern of the individual. 6. Angle N – S – Ar: Saddle angle 7. Angle S – Ar – Go: Articular angle 8. Angle Ar – Go – Me : Gonial angle 9. Angle FH – Mandibular plane angle: indicates unfavorable hypo or hyperdivergent facial patterns. 10. Angle PP – MP: Maxillo mandibular plane angle. 11. Angle OP – SN: Measures the occlusion of teeth in relation to the face and the skull. 12. Anterior facial height (N-Me) : To check for facial growth pattern of subjects (Horizontal or vertical) 13. Posterior facial height (S-Go) : To check for facial growth pattern of subjects (Horizontal or vertical) 14. Ramus height (Go – Ar): To measure the height of the ramus. 15. Mandibular unit length (Co – Gn): To determine the linear growth of mandible. 16. Mandibular body length (Go – Me): To determine the linear growth of mandible 17. U1 – NA (mm) and (0): Indicates the relative angular and linear measurements of upper incisor teeth to the facial skeleton. 18. U1 – SN (0): Indicates the relative angular position of the upper incisor to the cranial base. 19. L1 – NB (mm) and (0): Indicates the relative angular and linear measurements of lower incisor teeth to the facial skeleton. 20. Angle IMPA: To determine the inclination of the lower incisor teeth in relation to the mandibular plane. 21. Interincisal angle: To know the inclination of the upper and lower incisor teeth relative to each other. 22. Overjet: To determine the horizontal overlap of maxillary and mandibular anterior teeth. 23. Overbite: To determine the vertical overlap of maxillary and mandibular anterior teeth 24. Maxillary molar position : To check for occlusion 25. Mandibular molar position : To check for occlusion All the angles and linear parameters of pre and post treatment lateral cephalometric radiographs will be measured. The mean and standard deviation will be calculated for each cephalometric variable. The data will be tabulated and comparison of T1 and T2 readings will be statistically analyzed. Pre and post mean values will be subtracted to obtain the net change achieved. Thus for each set of pretreatment and post treatment cephalometric measurements taken from the patient, an equivalent set will be obtained from the controls matched for age and sex. To determine the accuracy of the cephalometric measurements, 10 cephalograms will be randomly selected and retraced after a period of 20 days. A paired t test will be applied to the first and second measurements and the difference will be analysed statistically. All statistical analyses will be performed using the Statistical Package for the Social Sciences for Windows software package (SPSS for Windows, version 17.0, SPSS Inc ). 4. Statistical Analysis: The results thus obtained will be statistically analyzed using 1. Paired Student ‘t’ test to compare the mean differences between pretreatment and post treatment measurements of preorthodontic trainer and twin block appliance groups and the first and second observation period measurements for the control group. 2. One way ANOVA to determine whether there are any significant differences between the means of three independent (unrelated) groups. 3. TUKEYS test to analyze simultaneously the pair wise comparison and determine which treatment effect is statistically significant than the other. 7.3 Does the study require any investigation or intervention to be conducted on patients or other human or animal? If so, please describe briefly. Yes. The study requires lateral cephalograms of Class II Division I malocclusion patients as a part of investigation. 7.4 Has ethical clearance been obtained in case of above? Yes. Copy of the ethical clearance is enclosed. LIST OF REFERENCES: 1. Patti A, Perrier D’ARC G. Clinical Success in Early Orthodontic Treatment. Paris: Quintessence Books; 2009. 2. Clark WJ. Twins block functional therapy- Applications in dentofacial orthopaedics. 2nd ed. Spain: Mosby; 2002. 3. Usumez S, Uysal T, Sari Z, Basciftci, Karaman AI, Guray E. The Effects of Early Preorthodontic Trainer Treatment on Class II Division 1 Patients. Angle Orthod 2004; 74:605–609. 4. Tiziano Baccetti, Lorenzo Franchi, Linda Ratner Toth and James Mcnamara Jr. Treatment timing for twin block therapy. Am J Orthod Dentofacial Orthop. 2000; 118:159 – 170. 5. Aleksić E, Lalić M, Milic J, Gajic M, Milovanović MM, Stojanović Z et al. Trainer System Appliances in Early Treatment of Malocclusions. Serbian Dental Journal. 2012; 59(2):96 – 100. 6. Ramirez-Yanez GO. The Trainer System in the context of treating malocclusions. Part 1. Ortho Tribune. 2009. 7. Antanas Šidlauskas. The effects of the Twin-block appliance treatment on the skeletal and dentoalveolar changes in Class II Division 1 malocclusion. Medicina (Kaunas) 2005; 41(5) 8. Lund DI, Sandler PJ. The effects of twin blocks: A prospective controlled study. Am J Orthod Dentofacial Orthop 1998;113:104-10. 9. Mills CM, McCulloch KJ. Treatment effects of the twin block appliance: A cephalometric study. Am J Orthod Dentofacial Orthop 1998;114:15-24. 10. Trenouth MJ. Cephalometric evaluation of the twin block appliance in the treatment of Class II division I malocclusion with matched normative growth data. Am J Orthod Dentofacial Orthop 2000; 117:54-9. 11. Oliveira Jr EB, Nouer PR, Almeida RC, Nogueira FF, Yanez GO. Cephalometric assessment of patients after treatment with Trainer positioners - T4K. J Br Orthod Orthop Facial 2005; 10 (56):179-85. 12. Das UM, Reddy D. Treatment effects produced by preorthodontic trainer appliance in patients with Class II Division I malocclusion. J Indian Soc Pedod Prevent Dent 2010 Jan-Mar; 28(1): 30 – 33. 9 Signature of the Candidate 10 Remarks of Guide . 11. 11.1) Name and designation of Guide (in block letters) Dr. SAVITHA N. S., MDS SENIOR PROFESSOR & HOD, DEPARTMENT OF PEDODONTICS KVG DENTAL COLLEGE AND HOSPITAL SULLIA 11.2) Signature of the Guide 11.3) Head of Department Dr. SAVITHA N. S., MDS SENIOR PROFESSOR & HOD, DEPARTMENT OF PEDODONTICS KVG DENTAL COLLEGE AND HOSPITAL SULLIA 11.4) Signature of Head of the Department 12. PRINCIPAL Dr. MOKSHA NAYAK, M.D.S. PRINCIPAL K.V.G. DENTAL COLLEGE AND HOSPITAL, KURUNJIBAGH, SULLIA. 12.1 Remark 12.2 Signature and official seal K. V. G. DENTAL COLLEGE & HOSPITAL KURUNJIBAGH - 574 327, SULLlA, D. K., KARNATAKA, INDIA SPONSORED BY ACADEMY OF LIBERAL EDUCATION (REGD.) SULLIA Department of Pedodontics and Preventive Dentistry CONSENT FORM Name of the Participant: ____________________________________________ Name of the Parent: _______________________________________________ Name of the Investigator: ___________________________________________ Name of the Institution: ____________________________________________ INFORMED CONSENT FOR PARTICIPATION IN RESEARCH I, Dr. JENCY SAMUEL JOHNSON, Post Graduate Student in Department of Pedodontics And Preventive Dentistry, am conducting a dissertation work for award of M.D.S degree in Pedodontics and Preventive Dentistry. The topic for the study A COMPARATIVE EVALUATION OF THE DENTOSKELETAL TREATMENT EFFECTS OF MYOFUNCTIONAL TRAINERS AND TWIN BLOCK APPLIANCES ON CLASS II DIVISION I MALOCCLUSIONS. AIMS AND OBJECTIVES OF THE STUDY: 1. To evaluate the effectiveness of pre fabricated orthodontic trainer by comparing the skeletal and dentoalveolar changes in a group of myofunctional orthodontic trainer treated Class II division I patients after active phase of treatment and untreated age and gender matched control group. 2. To evaluate the effectiveness of twin block appliance by comparing the skeletal and dentoalveolar changes in a group of twin block treated Class II division I patients after active phase of treatment and untreated age and gender matched control group. 3. To compare the post treatment cephalometric changes seen with prefabricated orthodontic trainer and twin block appliance on Class II division I malocclusions. MR/MS________________________________ , we are requesting you to enrol your child in the study conducted by Dr Jency Samuel Johnson, Post Graduate Student in department of Pedodontics And Preventive Dentistry under the guidance of Dr. Savitha N. S MDS at K. V. G. Dental College & Hospital, Sullia D.K. Your child has been requested to participate. During the study you will be asked some questions and you are supposed to answer them to the best of your knowledge. • Your child’s participation in research is voluntary. Your decision whether to participate your child will not affect your relationship with K. V. G. DENTAL COLLEGE & HOSPITAL. If you decide not to do so, you are free to withdraw him/her at any time. The purpose of research is to ANALYSE AND COMARE THE EFFECTS OF THE PREFABRICATED ORTHODONTIC TRAINER AND TWINBLOCK APPLIANCE TREATMENT ON THE SKELETAL AND DENTOLAVEOLAR CHANGES IN CLASS II DIVISION I MALOCCLUSIONS PROCEDURE INVOLVED: If you agree to participate in this research study we would ask you, your child’s past, present and family history. After detailed clinical examination and routine investigations your child will be treated conservatively or surgically depending upon the need. RISK AND BENEFITS: There may be risks involved in treatment either during treatment conservatively, or anaesthesia, or operation and during the post operative period. If any complications occur during the operation or during the post operative period, your child will be treated with best of our knowledge. There is no compensation or payment for such medical treatment. ALTERNATIVES: Even if you decline your child’s participation in the study, your child will get the routine line of management. PRIVACY AND CONFIDENTIALITY: The only people to know that you are a research subject are members of the research team. No information about you or provided by you regarding your child during the research will be disclosed to others without your written permission except: 1. In emergency to protect your rights and welfare. 2. If required by law. AUTHORIZATION TO PUBLISH RESULTS: When the results of the research are published or discussed, in a conference, no information will be displayed that would disclose your identity. Any information that is obtained in a connection with this study and that can be identified with you will remain confidential. FINANCIAL INCENTIVES FOR PARTICIPATION: You will not be paid/offered any free gifts for participating in the research. You will not be reimbursed for expenses. ETHICAL COMMITTEE CLEARANCE 1.TTILE OF DISSERTATION A COMPARATIVE EVALUATION OF THE DENTOSKELETAL TREATMENT EFFECTS OF MYOFUNCTIONAL TRAINERS AND TWIN BLOCK APPLIANCES ON CLASS II DIVISION I MALOCCLUSIONS. 2.NAME OF THE CANDIDATE DR. JENCY SAMUEL JOHNSON 3.NAME OF THE GUIDE DR. SAVITHA N. S. 4.APPROVED / NOT APPROVED APPROVED LAW EXPERT PRINCIPAL K.V.G DENTAL COLLEGE AND HOSPITAL ,SULLIA
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