PROTOCOL

STUDY TITLE: Prospective Comparative Study to Estimate the Prevalence of Periodontitis in Type 1 and Type 2 Diabetic and Non-Diabetic Patients.

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TITLE: Prospective Comparative Study to Estimate the Prevalence of Periodontitis in Type 1 and Type 2 Diabetic and Non-Diabetic Patients.

Protocol No: PPDN001

Version no: 1.0

Date: 1st April, 2012

Student M.Sc CR: Mohammad Afzal

Guide: Dr. SujeetJha, Endocrinologist

(Investigator) Max Super Speciality Hospital, Saket

Co-Investigator: Eshoo Kansal

Co-guide: Dr. Sangeeta Dheer

Guide: Dr. Fahad Haroon

(Jamia Hamdard)

Biostatistician: Ms. Kalpana Singh

Study Site: Max Super Speciality Hospital,

Saket, New Delhi.

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TABLE OF CONTENTSPage

1. INTRODUCTION....................................................................................................................................3

2. STUDY RATIONALE....................................................................................................................…….3

3. STUDY OBJECTIVES…………………………………………………………………………………4

1.1 Primary Objective……………………………………………………………………………………4

4. STUDY DESIGN................................................................................................................................…..4

5. SELECTION AND ENROLLMENT OF PARTICIPANTS...............................................................4

5.1 Inclusion Criteria ……………………………………………………………………………………4

5.2 Exclusion Criteria……………………………………………………………………………. ……...5

5.3 Study Enrollment Procedures……………………………………………………………………….5

6. STUDY PROCEDURES.........................................................................................................................5

7.. STATISTICAL CONSIDERATIONS………………………………………………………... ……...6

7.1 Hypothesis…………………………………………………………………………… ……...6

7.2 Sample Size………………………………………………………………………….………..........6

7.3 Statistical Analysis…………………………………………………………………………………6

7.4 Outcomes………………………………………………. ………………………………………...7

8. DATA COLLECTION…………………………………………………………………..……….........7

8.1 Data Collection Forms………………………………………………………………………………7

9. PARTICIPANT RIGHTS AND CONFIDENTIALITY......................................................................7

10.1 Institutional Ethics Committee………………………......................................................................7

10.2 Participant Confidentiality……………………..…...........................................................................8

10. PUBLICATION OF RESEARCH FINDINGS...................................................................................8

11. REFERENCES……………………………………………………………………………….8

12. SUPPLEMENTS/APPENDICES 8 I (A) Case Report Form Template

I (B) Dental PHP Form

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T1DM Type 1 diabetes mellitus

T2DM Type 2 diabetes mellitus

PHP Preventive Health Programme

ICF Informed Consent Form

CRF Case Report Form

IEC Institutional Ethics Committee

LIST OF ABBREVIATIONS

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SYNOPSIS

STUDY TITLE Prospect Prospective comparative study to estimate the prevalence of periodontitis in Type 1 and Type 2 diabetic and non-diabetic Patients .

PRIMARY OBJECTIVE To estimate the prevalence of periodontitis in diabetic as compared with non-diabetic patients in diabetic clinic.

DURATION Duration of the study is 3 months

TYPE OF STUDY Prospective Case-Control Study

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1. INTRODUCTION

Diabetes is a chronic disease which affects virtually every organ in the human system .India ranked number one as the country with the highest number of diabetes patients in 1995, at 31.7 million in 2000, with a projected 57.2 million in 2025, and 79.4 million in 2030, retaining its top position.

DM has acquired a pandemic status in India.Research in several countries indicates that 5 – 20% of any population will have severe PD and a majority of adults suffer from moderate forms of this disease. Evidence suggests that one out of two adults above the age of 35 years have PD in India, and 35% of the teeth extracted are as a consequence of PD. The diabetes is characterized by an increased susceptibility to infection, poor wound healing, and increased morbidity and mortality associated with disease progression. Altered collagen metabolism in diabetics would be expected to contribute to the progression of periodontal disease. Hyperglycemia impairs overall cell function, as insulin is required for glucose to enter cells to provide a source of energy.

Diabetes is also recognized as an important risk factor for more severe and progressive periodontitis, infection or lesions resulting in the destruction of tissues and supporting bone that form the attachment around the tooth. Both diseases are thought to share a common pathogenesis that involves an enhanced inflammatory response that can be observed at the local and systemic level. Periodontal disease has been reported as the sixth complication of diabetes, along with neuropathy, nephropathy, retinopathy, and micro- and macrovascular diseases. Many studies have been published describing the bidirectional interrelationship exhibited by diabetes and periodontal disease. Studies have provided evidence that control of periodontal infection has an impact on improvement of glycemic control evidenced by a decrease in demand for insulin and decreased hemoglobin A1C levels.

2. STUDY RATIONALE

Regarding the influence of diabetes on periodontium, there are two schools of thought. One school of thought has reported increased severity of periodontal disease in diabetics not related to increased local irritants. According to them angiopathy, abnormal collagen metabolism, abnormal polymorphonuclear cell (PMN) function, and altered sulcular microbial flora are found in close association with the severity of periodontitis in diabetic patients. These factors reduce the defensive capacity of tissues and may disturb the tissue response to local irritants. These diseases are thought to be associated biologically, and a number of reviews and studies have proposed mechanisms to explain the relationship, including- 1)microvascular disease, 2) changes in components of gingival crevicular fluid, 3) changes in collagen metabolism, 4) an altered host response, 5) altered subgingival flora, 6) genetic predisposition, and 7) non-enzymatic glycation.Both population based and mechanistic studies have examined the potentiating effects of periodontal infection in the presence of hyperglycemia and have demonstrated increased innate immune responses and periodontal tissue destruction related to an altered inflammatory response. Research in several countries indicates that 5 – 20% of any population will have severe PD and a majority of adults suffer from moderate forms of this disease.

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3. STUDY OBJECTIVES

3.1 Primary Objective

Estimation of the prevalence periodontitis in type 1 and type 2 diabetic patients as compared with non-diabetic patients.

4. STUDY DESIGN

A prospective observational study; two groups of patient to be enrolled to participate in the study; GroupA: 30 diabetic patients , GroupB: 30 patients without diabetes from routine dental health preventive programme.. The diabetic subjects will be evaluated with glycosylated hemoglobin (GHb) to determine the glucose control; clinical periodontal evaluations will be performed for all teeth in each subject and following indexes to be included: Plaque, gingival, , probing depth, attachment level, bleeding on probing, and marginal bone loss.

5. SELECTION AND ENROLLMENT OF PARTICIPANTS

Adequate number of subjects will be selected. Medical histories and demographic data, including name, sex, age, body weight (kg), height (cm) and tobacco use (including number of cigarettes smoked per day) will be recorded.

5.1 CASE Inclusion Criteria:

Subject aged over 18 years old. Patients having diagnosis of type 1 or type 2 diabetes as defined by American Diabetes

Association (ADA 2011) criteria. Subject able to provide consent to participate in the study.

5.2 CASE Exclusion Criteria:

Pregnant or Lactation women. Patient with recent dental treatment. Patients not willing to participate in the study.

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5.3 CONTROL Inclusion Criteria Males and females of age between 18-80. Absence of diagnosed type 1 and type 2 diabetes mellitus or any history of diabetes i.e.

HbA1c level< 6.5

5.4 CONTROL Exclusion Criteria Pregnant or lactating women. Inability or unwillingness of individual or representative to give written informed consent.

5.5 Study Enrollment Procedures

Patients with Type 1 and Type 2 diabetes visiting the diabetic clinic ,outpatient department of Max Super Speciality Hospital will be identified and enrolled in the study, if they meet all the inclusion criteria defined for the “case” group. Subjects from general population without type 1 and type 2 DM and fulfilling all the inclusion criteria defined for the “control” group will be enrolled.

6. STUDY PROCEDURES

Study would be based at the diabetic centre. Subject population would comprise of males and females of the age group (18-80 years) with and without diagnosed diabetes (type 1 and type 2). Subjects to be recruited as per criteria and their demographic variables, age, sex, duration of diabetes, Body weight and height ) BMI, history of smoking and alcohol, family history of diabetes, Family history of periodontitis, drugs regime for diabetes ( oral / insulin), home oral care (frequency of tooth brushing / flossing ) will be recorded. dental examination of both the groups of patient will be done.

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7. STATISTICAL CONSIDERATIONS

7.1 Hypothesis:

The primary effectiveness hypothesis being tested is:

H0: pT= pC vs. H1: pT ≠ pC

Where pT and pC are the proportion of depression in diabetes and non diabetes groups respectively, rejection of the null hypothesis at a two sided significance level of 0.05 indicates a significant difference between two arms.

7.2 Sample size:

By the previous study the prevalence of periodontitis in type I and type II diabetes mellitus was 68.18% and the prevalence of periodontitis in well controlled type ii diabetes mellitus was 31.82%. We need minimum 30 subjects in each group to achieve 80% power and 5 % level of significance.

Sample size required for 80% power (n 80%) and 90% (n 90%) for level of significance:

Level of significance

N (80%) N (90%)

1% 44 555% 29 3810% 23 31

7.3 Statistical Analysis:

Normally distributed data are presented as mean and standard deviation; non- normally distributed data are presented as medians quartiles (inter quartile range).Categorical data will be analyzed using chi-square analysis or Fisher’s exact test where applicable. Continuous data will be analyzed by t-test or Mann Whitney U test as appropriate. Multiple logistic regression will be used to find the risk of different predictor variables.

All data collected during the study will be included in data listings. Unless specified otherwise, all statistical testing will be two-sided and will be performed using a significance (alpha) level of 0.05. All statistical analyses will be conducted with the STATA System, version 9.0 and R (2.12).

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7.4 Outcome

Presence of periodontitis in type 1and type 2 diabetic and non-diabetic patients.

8. DATA COLLECTION

8.1 Data Collection Forms Data generated during the conduct of study will directly be entered into case report forms and will

then be recorded into the computerized format.

9. PARTICIPANT RIGHTS AND CONFIDENTIALIT Y .

9.1 Institutional Ethics Committee (IEC)/ Institutional Review Board (IRB) Review

This protocol will be reviewed by the Institutional Ethics Committee and the study subjects will not be enrolled until the Committee/Board has approved the protocol, as submitted or with modifications in subsequent version(s).

This research will be carried out in accordance with the Basic Principles defined in US 21 CFR Part 320, the ICH (62FR 25692, 09 May 1997) 'Guidance for Good Clinical Practice'. ICMR ‘ethical guidelines for biomedical research on human participants (2006)’, CDSCO‘ guidance on good clinical practice for clinical research India.

9.2 Participant Confidentiality

Information will not be released without written permission of the participant, except as necessary for monitoring by IEC and any regulatory authority.

10. PUBLICATION OF RESEARCH FINDINGS

After the completion of this study, we intend to immediately publish the results in international and national journals.

.

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11. REFERENCES

1. CHENG B, LAMSTER I B. Identification of unrecognized diabetes and pre-diabetes in a dental setting. J DENT RES. 2011 jul; 90(7):855-60. epub 2011 apr 29.

2. SILVESTRE FJ, The effect of periodontal treatment on metabolic control of type 1 diabetes mellitus. CLIN ORAL INVESTIG. 2008 dec;12(4):337-43. Epub 2008 apr 30.

3. SYRJÄLÄAM, P, NISKANEN MC, KNUUTTILA ML. Role of smoking and hba1c level in periodontitis among insulin-dependent diabetic p atients. J CLIN PERIODONTOL. 2003 oct;30(10):871-5.

4. Barasch A, , Safford MM, Gesko D, Qvist V, Palmore O, Gilbert GH, The Dental Practice-Based Research Network Collaborative Group. A community-based feasibility study from The Dental Practice-Based Research NetworkAvailable From:http://jada.ada.org/content/143/3/262

5. Acharya AB, Satyanarayan Aparna,  and Thakur SL, status of association studies linking diabetes mellitus and periodontal disease in india, copyright © international journal of diabetes in developing countries.

6. Screening for type 2 diabetes [cited 2012 Mar 20] Available From http://care.diabetesjournals.org/content/26/suppl_1/s21.full

7. Santos VR, Lima JA, De Mendonça AC, Braz Maximo MB, Duarte PM. Effectiveness of full-mouth and partial-mouth scaling and root planing in treating chronic periodontitis in subjects with type 2 diabetes. j periodontol. 2009 aug;80(8):1237-45.

8. Preshaw , N De Silva , GI McCracken , DJ Fernando , CF Dalton , ND Steen ,   PA Heasman .compromised periodontal status in an urban Sri Lankan population with type 2

diabetes. j clin periodontol. 2010 feb;37(2):165-71

9. F Tanwir , M Altamash , A Gustafsson .Effect of diabetes on periodontal status of a population with poor oral health. acta odontol scand. 2009;67(3):129-33.

13. SUPPLEMENTS/APPENDICES

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APPENDIX 1 (A):

CASE REPORT FORM

Date (dd/mmm/yy):____________ Patient ID: _______________ Age/ DOB____________Gender: M F Attending doctor: _________________________Diabetes TYPE 1 TYPE 2 Personal and family history Occupation House wife | Full time | Part time | Student | Unemployed | RetiredJob nature Professional | Managerial | Non manual | Manual skilled | Manual non-skilled | Others Highest education attained College | Higher school (>11 yrs) | Middle school (>6 & <11 yrs) | Primary or illiterate (<6 yrs) | Others Smoking Y | Ex | Never Number of cigarettes/day 0 | <5 | 5~20 | 20~40 | 40 × ________ yearsAmount of alcoholEx | Never | Occasional | Regular (____units/wk)Significant family history1Diabetes1 Father | Mother | Sibs | UK2

Renal disease1 Y | N | UKPremature CVD 1,3 Y | N | UKTobacco Y / N / UK Cancers Y | N | UKDetails: __________________________________________________________ Diabetes related complications, illnesses and symptomsYear of Diagnosis _________________Symptoms at presentation: _____________________________________________________Definite Type 1 diabetes4 Y | N | UKAll heart events (with year)CHD5 Y | N | UK ________ |Coronary intervention (e.g. CABG/PCI6) Y | N | UK ________ |Myocardial infarction Y | N | UK ________ |Cardiac failure Y | N | UK ________Stroke (with year)Stroke with full recovery Y | N | UK ________ |Completed stroke Y | N | UK ________Peripheral vascular disease (PVD) (with year)Non-traumatic below ankle amputation Y | N | UK ________ |Non-traumatic above ankle amputation Y | N | UK ________ |Treatment for PVD (Revascularization) Y | N | UK ________Renal failure (with year)Renal transplantation Y | N | UK ________ |

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Dialysis Y | N | UK ________ |Type of Dialysis: Peritoneal | Hemo | UndefinedDiabetes related illnessesHistory of Hypertension Y | N | UKBP lowering drugs Y | N | UK Start year_______

Lipid regulating drugs Y | N | UK Start year_______Anti-diabetic treatment

Lifestyle changes only | OAD7 | Insulin | BothDiabetes related symptomsCalf pain on walking | Impotence | Abnormal sensation in lower limbs | Coughing | Shortness of breath | Edema | Chest pain__________________________________________________________________________________________________________________________________________________________________

Diabetes education | Follow-up | Self careRegular follow-up At least once in last 12 months Y | N Type of follow-up (can tick more than 1) Hospital based clinic | Community based clinic |Herbalist | Self medication | No follow up | OthersType of clinic Private | Public | SubsidizedEducation by dietitian Y | N | UKEducation by podiatrist Y | N | UKEducation by DM nurses Y | N | UKFrequency of hypoglycemia in last 3 monthsNone | < once monthly | At least once monthly | At least once weekly | At least dailyNature of hypoglycemic attackMild | Moderate | Severe8Number of severe hypo attacks requiring medical attention in last 3 months ________Self monitoring of glucose controlBlood | Urine | Both | NoneSelf monitoring in last 3 monthsNone | < once monthly | At least once monthly | At least once weekly | At least daily Physical activity in last 3 months9No regular activity | < 3 times/week |3-4 times/week | 5 times/week | > 5 times/weekAdherence to balanced diet in last 3 monthsY | N | Occasional | Never

Cancers and other medical conditionsMajor operations (with year):Other illnesses (with year):Types of cancer (with year):Lung ________ | Breast ________ | Gynecological ________ | Hepato-biliary _______ | Prostate ________ | Colo-rectal ______ | Upper GI ________ | NPC10________ | Others ________ Active treatment Y | NKnown hepatitis B carrier Y | N | UK

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Physical examinationObesityHeight m Weight kgWaist cm Hip cmBMI WHR BP R arm ___/___mmHg L arm ____/___mmHg

Pulse beats/min:

Urine multistix testRBC -ve | trace | +ve | ++ | ≥ 3+Ketone -ve | trace | +ve | ++ | ≥ 3+Protein -ve | trace | +ve | ++ | ≥ 3+

Eye examination R eye L eyeVisual acuity11 20 / 20/If>20/200 C F | H M |LP|NLP12 CF|HM|LP|NLPHistory of glaucoma Y | N | UK Y | N | UKHistory of cataract surgery Y | N | UK Y | N | UKHistory of laser treatment Y | N | U K Y | N | UKHistory of retinal surgery Y | N | U K Y | N | UKFundus photo taken Y | N | UK Y | N | UKRetina seen by doctor Y | N | U K Y | N | UKCataract seen by doctor Y | N | U K Y | N | UK

Diabetic Retinopathy (DMR)Clinic in the community:Laser scars (seen by doctor) Y | N | UK Y | N | UKDMR (seen by doctor) Y | N | UK Y | N | UKOR Hospital / Specialist clinic, Specify details (OPTIONAL):Maculopathy Y | N | UK Y | N | UKNon-proliferative Y | N | UK Y | N | UKPre-proliferative Y | N | UK Y | N | UKProliferative Y | N | UK Y | N | UKAdvanced eye disease Y | N | UK Y | N | UKFoot exam R foot L footPVD (doctor diagnosed) Y | N | UK Y | N | UKSensory neuropathy (doctor dx) Y | N | UK Y | N | UKSpecify details of foot examination (OPTIONAL)

↓ Touch 13 Y | N | U K Y | N | UKVibration14 _____/ 8 _____/ 8↓ Pulse (Dr’s palpation) Y | N | UK Y | N | UKAbnormal wave (Doppler) Y | N | UK Y | N | UKAnkle systolic BP (Doppler) ____mmHg ___mmHgAnkle:brachial ratio (ABR) Acute foot ulcer or gangrene Y | N | U K Y | N | UK

Foot deformities (can tick more than one):Charcot arthropathy | Claw toes | Digital contractures |Hammer toes | None

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Skin abnormalities (can tick more than one):Callus | Dry skin | Fungal infection | Healed ulcers |Nail dystrophy | Paronychia | None

Laboratory resultsRenal function testPlasma sodium Plasma potassium Plasma urea Plasma creatininePlasma uric acid Plasma calcium Plasma phosphateUrine albumin Urine creatinine Urine ACR

HaematologyHaematocrit HaemoglobinPlatelet White cell count

Liver function testALP ALT Albumin Bilirubin GGT

Metabolic controlTotal cholesterol HDL-C Triglyceride LDL-C HbA1c Fasting PG Random PG

Special investigationsNovel risk markers & others (with Units) Abnormal cardiac imaging Y | NC peptide hsCRP TSH Type of cardiac imagingFasting insulin serum B12 folate CT | MRI | Angiogram | OthersHOMA-IR HOMA-β Details:

Abnormal CXR Y | N Details:

Carotid IMT (date: _________) R carotid L carotidMean mm mmMaximal mm mmPlaque Y | N Y | NAbnormal Y | N Y | N

Abnormal ECG Y | NECG abnormalities LVH15| AF16 | ST changes | Old MI changes | Others:

Abnormal stress test Y | N Ultrasound scan (date: ______) Details:Type of stress test Kidney abnormalities Y | NTreadmill | Echo | Isotope scan Fatty liver Y | NDetails: DetailsOther investigations:

Quality of Life (tick one for each section) Reasons for suboptimal risk factor control :1. Mobility (can tick more than one)I have no problems in walking about Change in diet | Change in activity |

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I have some problems in walking about Change in weight | Change in lifestyle |I am confined to bed Change in Rx | Change in stress level |2. Self-Care Change In medication compliance | OthersI have no problems with self-care I have some problems washing or dressing myself I am unable to wash or dress myself 3. Usual Activities (e.g. work, study, housework, family or leisure activities)I have no problems with performing my usual activities I have some problems performing my usual activities I am unable to perform my usual activities 4. Pain/DiscomfortI have no pain or discomfort I have moderate pain or discomfort I have extreme pain or discomfort 5. Anxiety/DepressionI am not anxious or depressed I am moderately anxious or depressed I am extremely anxious or depressed

We would like you to indicate on this scale how good or bad your ownhealth is today, in your opinion (best=100, worst=0).

Scale: 0……………………………………….100

Drug allergy (details):

Medications HistoryGeneric name

Dosage Freq Duration ofPrescription

NewRx

Repeat StartDate

DiscontinuationDate

Anti-diabetic and anti-obesity drugsY / N Y / NY / N Y / NY / N Y / NY / N Y / NY / N Y / N

Drugs for BP, angina and heart failureY / N Y / NY / N Y / NY / N Y / NY / N Y / N

β blockers, anti-arrthymics, inotropesY / N Y / NY / N Y / N

Anti-thrombotic and lipid regulating drugsY / N Y / NY / N Y / N

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GI Drugs and analgesicsY / N Y / NY / N Y / N

Other endocrine drugsY / N Y / NY / N Y / N

Drugs for erectile dysfunction, central nervous & respiratory systemY / N Y / N

Drugs being discontinued in this visit:

Ad-hoc drugs given in this visit:

^Action items

Recommended date of next contact: Agreed date of next contact:

Other referrals:

DM nurse Y | NDietitian Y | NPodiatrist Y | NDentist Y | NOther specialists Y | NOthers:

Other investigationsBlood test Y | NUrine test Y | NSpecial investigations Y | NDetails:

APPENDIX 1 (B):

DENTAL PHP FORM

Patient ID:

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Age:

Sex:

Date:

Medical Condition: Yes No

1.Have you undergone under any dental treatment earlier?

2.Have you ever been hospitilised for any other ailment?

3.Do you consume tobacco on any form ,smoking or chewable?

ON EXAMINATION TEETH:

Decayed: Few: Multiple:

Stains:Calculus:Root Stumps:Any other:

GINGIVA:

Normal: Yes/NoBleeding on Probing:Surface Texture:Colour:Suppuration:Size:Shape:

PERIODONTAL POCKETS: Yes/no Depth:

ORAL MUCOSA: Buccal: Palatal: Floor of mouth:

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TONGUE: Normal/Fissured

OTHER FINDINGS:

Xerostomia:Burning sensation:Bad taste:

PROVISIONAL DIAGONOSIS

APPENDIX 2Site Consent Version 1.0 English Subject ID: Number_________Site Consent Version 1 April 2012

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INFORMED CONSENT TO PARTICIPATE IN A STUDY

TITLE: Prospective Comparative Study to Estimate the Prevalence of Periodontitis in Type 1 and Type 2 Diabetic and Non-Diabetic Patients.

PROTOCOL NUMBER: PPDN001

PROTOCOL DATE: 1st April 2012

INVESTIGATOR: Dr. Sujeet Jha MAX Super Speciality Hospital 2, Press Enclave Road New Delhi – 110017TELEPHONE: 9910609000

INTRODUCTION

This study is designed and initiated by Dr.Sujeet Jha, alongwith a post-graduate Clinical Research student. This is a prospective case-control study which will be conducted at the out-patient department of Max Super Speciality hospital. It will include two groups of subjects, one comprising of patients with diagnosed type 1 or type 2 diabetes and another group will be a control group of subjects without diabetes.

Before you agree to join this research study, it is important that you read and understand the following information about the study. This document describes your right to withdraw from the study at any time. Please read this consent form carefully and ask as many questions as you like before deciding whether you want to take part in this study.

PURPOSE OF STUDY AND BACKGROUNDThe purpose of this study is to estimate the prevalence of periodontitis in type 1 and type 2 diabetic patients as compared to those without diabetes in a diabetic clinic and to extend our understanding of the relationship of periodontitis to diabetes.

Diabetes is a chronic disease which affects virtually every organ in the human system. The World Health Organization projected that 300 million people will suffer from diabetes by 2025. India has the largest number of diabetic population in the world and it is expected that there will be 69.9 million diabetic populations in India by 2025. Site Consent Version 1.0 English Subject ID Number_________Site Consent Version 1 April 2012

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Periodontitis  is a set of inflammatory diseases affecting the periodontium, i.e., the tissues that surround and support the teeth. Periodontitis involves progressive loss of the alveolar bone around the teeth, and if left untreated, can lead to the loosening and subsequent loss of teeth. Periodontitis is caused by microorganisms that adhere to and grow on the tooth's surfaces, along with an overly aggressive immune response against these microorganisms. A diagnosis of periodontitis is established by inspecting the soft gum tissues around the teeth with a probe (i.e. a clinical exam) and by evaluating the patient's x-ray films (i.e. a radiographic exam), to determine the amount of bone loss around the teeth.

STUDY OUTLINE

A total of 60 patients will participate in this study, out of which30 will be having type 1 type 2 Diabetes and other 30 will be those without Type 1 and type 2 diabetes. All those patients visiting the OPD at Max Hospital with type 1 and type 2 diabetes mellitus and fulfilling the defined inclusion criteria for the “Case” group of the study will be eligible to participate in this study (Group 1), and those from general population without diabetes mellitus and fulfilling defined criteria for “Control” group will be eligible for participation (Group 2).

The study has only one part, the initial contact requesting your participation and collecting the required information.Your dental examination will be done.

STUDY PROCEDURES

Enrollment

If you are willing to participate in the study, please read and sign this consent form and provide your contact details.

Site Consent Version 1.0 English Subject ID Number_________Site Consent Version 1 April 2012

Providing contact information is required to ensure complete follow-up of all patients (if

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required) and to make sure that the data collected are precise. Once you have read and signed the informed consent, please return the form to the co-ordinating person at the site. All the clinical information required will be obtained from your medical reports. The study does not require you to take any experimental medications.

PATIENT RESPONSIBILITIES

While you do not bear any responsibility towards the study, it is important for you to be completely truthful with us regarding your health history.

RISKS and BENEFITS

This study put your health at minimal risk. While you may not directly benefit from this study, your participation may yield information that could benefit other diabetic patients around the world suffering from periodontitis.

CONFIDENTIALITY

Your medical records will be treated as confidentially as possible under local, state and federal laws. All personal information obtained, including your name, address, date of birth, medical history, and clinical data in relation to the study will be used for the purposes of research and medical education. Such information will be kept confidential and only authorized personnel will have access to it. Data collected from study participants therefore, will never identify study participants by name but by a code number. The personal information will be kept at the investigator’s office of the hospital conducting the study.

Results of the study may be published, but your identity will never be revealed.

You can access your data upon written request sent to,

Dr. Sujeet JhaMax Super Speciality Hospital2, Press Enclave RoadNew Delhi- 110017Ph- 9910609000

Site Consent Version 1.0 English Subject ID Number_________Site Consent Version 1 April 2012

IRB CONTACT

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For more information about your rights as a research participant,Contact:

COSTS

There will be no charge to you for your participation in this study.

VOLUNTARY PARTICIPATION AND EARLY WITHDRAWAL

Taking part in this research study is voluntary. You may refuse to take part or you may withdraw from the study at any time for any reason without penalty and without any effect on your future medical care. The study staff is required, by law, to respect your wishes to not continue participation in this study.

Site Consent Version 1.0 English Subject ID Number_________Site Consent Version 1 April 2012

Protocol No. PPDN001, Version No. 1.0, Dated 1st April 2012

EC Contact Person: Prof.Arun K. Aggarwal Chairperson

Name of the EC : Max Healthcare Ethics Committee

Telephone: 011-23231478

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CONSENT TO PARTICIPATE

I understand that I remain free to withdraw from this study at any time and this will not prejudice or change my future care.

I have read and understand the purpose of this study, the procedures that will be used, the risks and benefits associated with my involvement in the study and the confidential nature of the information that will be collected and disclosed during the study.

I have had the opportunity to ask my questions regarding the various aspects of this study and my questions have been answered to my satisfaction.

I, the undersigned, agree to participate in this study and authorize the collection and disclosure of my personal information as outlined in this consent form. I understand that I will be given a copy of the signed information sheet and consent form.

________________________ _______________Subject’s Signature Date

________________________Subject’s Printed Name

Subject’s residential address

____________________________________________________________________________

____________________________________________________________________________

Subject’s telephone number:________________ Alternate telephone number: ______________

Site Consent Version 1.0 English Subject ID Number_________Site Consent Version 1 April 2012

STUDY PERSONNEL STATEMENT

Protocol No. PPDN001, Version No. 1.0, Dated 1st April 2012

21

Confidential

The person signing this consent form has had the study fully and carefully explained and has been given an opportunity to ask any questions regarding the nature, risks and benefits of the subject’s participation in this research study.

___________________________________ ________________Signature of Person Obtaining Consent Date

___________________________________ _________________Printed Name of Person Obtaining Consent Date

_______________________________ _________________Signature of Site Investigator Date

_______________________________Printed Name of Site Investigator

Protocol No. PPDN001, Version No. 1.0, Dated 1st April 2012

22