Annexure- II proforma for registration of subjects for dissertation



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Rajiv Gandhi University of Health Sciences

Karnataka, Bangalore



ANNEXURE- II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1.

NAME OF THE CANDIDATE AND ADDRESS

DR ANJANA RAMANATHAN

#202, PRESTIGE OZONE,

WHITEFIELD,

BANGALORE-560060



2.

NAME OF THE INSTITUTION

VOKKALIGARA SANGHA DENTAL COLLEGE AND HOSPITAL

3.

COURSE OF STUDY AND SUBJECT

MASTER OF DENTAL SURGERY IN ORAL MEDICINE AND RADIOLOGY

4.

DATE OF ADMISSION TO THE COURSE

JULY 2013

5.

TITLE OF TOPIC

A COMPARATIVE STUDY OF ORAL HEALTH STATUS BETWEEN TYPE 2 DIABETICS AND NON DIABETIC SUBJECTS

6

BRIEF RESUME OF THE INTENDED WORK

6.1

NEED FOR THE STUDY

More than 371 million people have Diabetes mellitus and half the patients are undiagnosed. 4.8 million people have died due to Diabetes. A large epidemiologic study on oral health has found that several oral soft tissue lesions were more prevalent in subjects with Diabetes.

Patients with diabetes not only showed an increased prevalence of oral and mucosal alterations such as fissured tongue, irritation fibroma and traumatic ulcers but also a significant percentage of potentially malignant disorders.1

Chronic hyperglycemia leads to several events that promote structural changes in tissues and are associated with impaired wound healing, higher susceptibility to infections and micro and macrovascular dysfunctions.2

Enhanced adhesiveness of Candida to tissue surfaces has been detected in diabetes mellitus which is a pre requisite for Candidal infection.3 An association has been shown between occurrence of one or more oral mucosal lesions and metabolic control of diabetic patients.5

With this study we aim to evaluate Oral health in Type 2 Diabetics and compare it with that of non diabetics which could be an early indicator for Diabetes and effective for prompt treatment and prevention of complications in diabetics.



6.2

REVIEW OF LITERATURE

A study was done to determine the prevalence and characteristics of oral soft tissue disease in adults with diabetes and control. Twice as many subjects with diabetes were found to have one or more soft tissue lesions such as fissured tongue, irritation fibroma, traumatic ulcers when compared to controls.1

A study to identify prevalence and possible risk factors for mucosal alterations in diabetics showed more prevalence in diabetics with significant difference to developmental conditions, potentially malignant disorders and fungal infections.2

A study with cytological smear from midline dorsal tongue from diabetic patients showed Candidal pseudohyphae and oral soft tissue manifestations of candidiasis such as Median rhomboid glossitis, denture stomatitis, generalized atrophy of tongue papillae and angular cheilitis were more prevalent in subjects with Non-Insulin dependent diabetes mellitus than control patients.3

A study with the aim of studying oral health in patients with type 2 Diabetes mellitus showed that these patients more often suffered from Xerostomia, advanced periodontitis and initial caries than non diabetics.4

A study on non oral habit diabetic patients to assess the association of Diabetes mellitus with oral precancerous lesions showed around 45% of diabetics had one or more oral mucosal lesions compared to non diabetics and an association between the metabolic control in diabetic subjects.5



6.3

OBJECTIVES OF STUDY

To find out the proportion of oral soft tissue lesions in subjects with Type 2 Diabetes mellitus.

To find out the proportion of oral soft tissue lesions in non diabetics

To compare the association of oral soft tissue lesions in diabetic and non diabetic patients.



7

MATERIALS AND METHODS

7.1

SOURCE OF DATA

50 patients, known cases of Type 2 diabetes mellitus, diagnosed at least 5 years prior to study, reporting for regular dental check up at the outpatient clinic of department of Oral Medicine and Radiology at VSDCH, Bangalore will be selected for the study.

50 patients, tested negative for diabetes mellitus, age and gender matched with the case selected patients reporting for regular dental check-up at the outpatient clinic of department of Oral Medicine and Radiology at VSDCH, Bangalore will be selected for the study as controls.


7.2

METHOD OF COLLECTION OF DATA

Inclusion criteria

  1. Patients with Type 2 Diabetes mellitus diagnosed at least 5 years prior to study, under medication.

  2. Age between 20 and 60

Exclusion criteria

  1. Cases of Gestational diabetes

  2. Patients with Diabetes mellitus secondary to other conditions such as Pancreatic disease, Endocrine disorders, Drug induced, Congenital lipodystrophy, Acanthosis nigricans.

7.3

PLACE OF STUDY

Department of Oral Medicine and Radiology, V.S.D.C.H, K R Road, VV Puram, Bangalore, Karnataka.



7.4

STUDY DESIGN

Comparative study



7.5

STUDY DURATION

One and a half years



7.6

SAMPLE DESIGN

Systematic Randomized Sampling



7.7

SAMPLE SIZE

50 diabetic patients

50 non diabetic patients


7.8

PROPOSED STATISTICAL ANALYSIS

Z Test, Mann-Whitney test



7.9

METHODS

A total of 100 patients were given description of study and questionnaire requesting demographic data, medical history and written informed consent will be obtained.

Each patient is clinically examined for:


  1. Number of natural teeth, presence and absence of teeth.

  2. Presence of soft tissue lesions such as Irritation fibroma, Fissured tongue, Traumatic ulcers, Median rhomboid glossitis, Denture stomatitis, Generalized atrophy of tongue papillae and Angular cheilitis.

  3. Periodontal status

  4. Xerostomia

  5. Candidal lesions

Periodontal status: Clinical examination is done by probing for pockets, recording gingival recession and tooth mobility. 4 bitewing radiographs with vertical position and proximal bone level will be classified from radiographs on 5 grade scale according to

Sandberg G.E et al4



0

No loss of supporting bone tissue

1

Initial loss of supporting bone tissue

2

Loss of supporting bone tissue not exceeding 1/3 of calculated root length

3

Greater than or more than 1/3 loss of supporting bone tissue

4

Angular bone defects or loss of bone in furcation for multi rooted teeth

Grades 1 - 2 were diagnosed as mild periodontitis

Grades 3 - above as advanced periodontitis.



Xerostomia: Patient’s subjective feeling of dry mouth is taken note of and salivary function assessed by 2 self-report measures.

Unstimulated flow determination- Patient is instructed not to swallow for 5 minutes and expectorate into funnel inserted into graduated collection vial.

Stimulated flow determination: Patient is asked to chew on a 1 inch square of Paraffin for 2 minutes and expectorate into funnel inserted into a graduated collection vial and measured.

Candidal infection

Cytological samples for Candida pseudohyphae were obtained by scraping a wet tongue depressor 4 times across the posterior midline dorsal tongue. Material was spread on a glass slide on an area of 2cm, fixed with fixative and allowed to dry. Slides were stained with periodic acid Schiff stain and studied for pseudohyphae.

For all the subjects, all recorded data will be tabulated and analyzed statistically and compared with controls.


7.4

Does the study require any investigation or interventions to be conducted on patients or other humans or animals? If so, please describe briefly.

Yes, patient is subjected to Saliva collection, Radiographic investigation and Cytological sample collection from tongue.



7.5

Has ethical clearance been obtained from your institution?

Yes.


8

LIST OF REFERENCE

  1. Guggenheimer J, Moore P.A, Rossie K et al, Insulin-dependent diabetes mellitus and oral soft tissue pathologies Prevalence and characteristics of non-candidal lesions. J. Oral Surgery, Oral Medicine, Oral pathology 2000;89:563-569

  2. Bastos A.S, Leite A.R.P, Spin-Neto R et al, Diabetes mellitus and oral mucosa alterations: Prevalence and risk factors 2011;92:100-105

  3. Guggenheimer J, Moore P.A, Rossie K et al, Insulin-dependent diabetes mellitus and oral soft tissue pathologies Prevalence and characteristics of Candida and Candidal lesions. J. Oral Surgery, Oral Medicine, Oral pathology 2000;89:570-576

  4. Sandberg G.E, Sandberg H.E, Fjellstrom C.A et al, Type 2 diabetes and oral health A comparison between diabetic and non diabetic subjects. Diabetes Research and Clinical Practice 2000;50:27-34

  5. Saini R, Al-Maweri S.A, Saini D et al, Oral mucosal lesions in non oral habit diabetic patients and association of diabetes mellitus with oral precancerous lesions, Diabetes Research and Clinical Practice 2010;89:320-326

9.

SIGNATURE OF THE CANDIDATE

10.

REMARKS OF THE GUIDE

11.

NAME AND DESIGNATION OF

GUIDE


SIGNATURE

DR. DEEPAK TA

PROFESSOR

DEPT OF ORAL MEDICINE AND RADIOLOGY

V.S DENTAL COLLEGE & HOSPITAL

BANGALORE.




HEAD OF DEPARTMENT

SIGNATURE



DR MANJUNATH.M

PROFESSOR AND HOD

DEPT OF ORAL MEDICINE AND RADIOLOGY

V.S. DENTAL COLLEGE& HOSPITAL



12.

Remarks of the Chairman and Principal

SIGNATURE





Consent Form

I ___________________son/daughter of ______________, aged ________

resident of ____________________ being under the treatment of

Dr Anjana Ramanathan do hereby give consent to perform proposed drugs/medical/surgical/anesthesia/diagnostic procedure of upon myself. The procedure has been explained to me in my own language and also likely adverse effects of the drugs being used has been explained and I agree that no responsibility will be attached to the surgeon or the hospital staff.

Signature of witness:

Place: Signature of the patient/relative



Date:


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