Dr. PREETHIKA GB
Post graduate student
Department of Oral Medicine and Radiology
Bangalore
ANNEXURE II
NULL HYPOTHESIS (H1): There will not be any difference in oral manifestations
between the groups.
Yuan Lee, Tianan,Taiwan(2005) Examined dental conditions and other oral conditions in
patients with diabetic and non-diabetic chronic renal failure undergoing hamodialysis and
concluded that significant increase was seen in dental caries and severe dry mouth, taste
changes, and mucosal pain compared to non diabetic group , and also pre-dialytic pH of
saliva of patients with diabetes was lower than the non diabetic group.4
Loureiro , Jacobo Limeres Posse , Lucía García Caballero, Pedro Diz Dios(2007) in
their study on Oral health status in patients with moderate-severe and terminal renal failure
concluded that Patients with CRF have more supragingival plaque, more teeth with a loss
of insertion and more missing teeth than the healthy controls. The prevalence of caries is
of patients undergoing hemodialysis and concluded that 100% of the patients undergoing
diseases (38.4%).approximately 70% of the patients had high DMFT index. These findings
led to the conclusion that patients on dialysis need comprehensive professional oral care
study on oral manifestations in diabetic and non diabetic chronic renal failure patients on
haemodialysis and arrived at a conclusion that prevalence of dental carries and periodontal
diseases was more in diabetic group whencompared to non diabetic group and salivary pH
Kaswan (2012) studied the nature, incidence, and severity of oral manifestations that occur
in chronic renal failure (CRF) in patients attending two hospitals in North Karnataka, in
comparison with healthy, disease-free controls and concluded that the most common oral
findings in the CRF patients were dry mouth (91%), pallor (87%), altered taste (42%),
and halitosis (34%). CRF patients showed significantly more oral changes than those in the
control group. These changes could be attributed to metabolic disturbances due to renal
failure.8
Health Status in Hemodialysis Patients concluded that the diabetic subjectswho were on
hemodialysis were at a high risk for developing periodontal disease and theyexhibited a
potential threat for dental decay and xerostomia. A lower salivary pH and a poor glycaemic
After obtaining written permission from the respective authorities, institutional ethical
committee clearance and with the informed consent of the patients , study subjects of 116
Chronic renal failure patients with and without Type II diabetes undergoing haemodialysis
in A.J Hospital and Research centre Mangalore will be chosen.
These patients will be divided equally into two groups of CRF patients each, with 58
diabetic and 58 non-diabetic patients depending on their fasting and post prandial blood
glucose level.
INCLUSION CRITERIA:
1 CRF patients who are diabetic patients for more than six months, and on maintenance
haemodialysis for more than a month
2 Non diabetic CRF patients who are on maintenance dialysis for more than a month
EXCLUSION CRITERIA:
1 Patients who received irradiation therapy for head and neck cancer
3. Patients with less than 6 months of history of diabetes and less than 1 month of
haemodialysis.
7.2 METHODS OF COLLECTION OF DATA:
A total of 116 patients with chronic renal failure undergoing hemodialysis for a month will
be divided into diabetic and non diabetic based on their history and fasting and postprandial
blood glucose level.
METHODOLOGY:
Laboratory investigation
Oral manifestations,
Dental caries
Periodontal evaluation.
Patients general medical history with history of chronic renal failure with its
eitiology and the duration of haemodialysis will be recorded using a standard case
history format.
2. Lab investigations:
Blood investigations like fasting and post prandial blood glucose tests will be
done to determine the blood glucose level and then the patients are grouped into
diabetic and non diabetic groups.
3. Salivary ph assessment:
4. Oral manifestations:
Oral manifestations seen is these patients will be classified into subjective findings
and objective findings.
Subjective symptoms like dry mouth change in taste perception and tongue and
mucosal pain will be assessed by a set of questionnaire and will be recorded as present or
absent.
3. Dentate health is assessed in two parts that is for dental carries using DMFT index
and for periodontal status using Community Periodontal Index.
DMFT index is used to check the prevalence of dental carries; recordings are
recorded as Decayed (D), Missing (M) and Filled (F) according to criteria’s of WHO for
each patient. All the teeth are examined; teeth excluded are third molars, congenitally
missing, unerrupted teeth and teeth extracted for reasons other than carries like trauma or
cosmetic reasons. Teeth with temporary restorations are considered as Decay and initial
lesions are not considered as decay. The DMFT value is obtained from the sum of decay
filled and missing tooth for each patient. Coding criteria is as follows
CPI index for periodontal status is assessed by using a CPITN probe which is a
specifically designed periodontal probe with a 0.5 mm ball tip and a black band between 3.5
and 5.5 mm and with rings at 8.5 and 11.5 mm from the ball tip and a mouth mirror and
according to WHO criteria the dentition is divided into sextants which are defined by tooth
numbers: 18-14, 13-23, 24-28, 38-34, 33-43, and 44-48, and it is coded as followed
The index teeth which will be examined are 17, 16, 11, 26, 27, 37, 36, 31, 46, and 47. If no
index teeth are present, all the remaining teeth in that sextant will be examined and the
highest code in the sexant will be recorded to identify the periodontal status.
INTERPRETATION OF RESULTS:
YES
7.4 Has ethical clearance been obtained from your institution in case of 7.3 ?
YES
INVESTIGATION DESIGN
CASE CONTROL STUDY
SAMPLE
SIZE 116
116
BLOOD INVESTIGATION: FASTIN AND
POST PRANDIAL GLUCOSE LEVEL
ORAL MANIFESTATIONS
Ulcerations
RESULTS
STASTSTIICAL ANALYSIS :
A cross-sectional study of 116 patients will be done .Data will be entered into the excel
sheet using SPSS version 19. Unpaired T test will be used to compare the two groups and p
value of less than 0.05 will be considered as significant
8. LIST OF REFERENCES :
1. De rossi SS, Glick M. Dental considerations for the patients with renal diseases
receiving hemodialysis. J Am Dent Assoc 1996;127:211-9
2. Kho HS, Lee SW, Chung SC, Kim YK .Oral manifestations and salivary flow rate,
pH, and buffer capacity in patients with end stage renal dialysis undergoing
hemodialysis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1999;88:316-9
3. Manfredi, M., et al.Update on diabetes mellitus and related oral diseases. Oral
dis 2004: 187-200.
4. Chuang SF, Sung JM, Kuo SC, Huang JJ, Lee SY. Oral and dental manifestations in
diabetic and non-diabetic uremic patients receiving hemodialysis. Oral Surg Oral
Med Oral Pathol Oral Radiol Endod. 2005 Jun; 99(6):689-95.
5. Marinho JSS ,Carmona IT, Loureir A , Posse JL,Caballero LG, Dios PD.Oral health
status in patients with moderate-severe.Med Oral Patol Oral Cir Buccal 2007;12;305-
10
9. Signature of Candidate
10. Remarks of the guide :
Dr. VATHSALA
PROFESSOR & HOD
Name & Designation of
DEPARTMENT OF ORAL MEDICINE AND
11.
11.1 Guide : RADIOLOGY
11.2 Signature :
11.4 Signature :
Dr. VATHSALA
11.5 Head of Department
PROFESSOR & HOD
Signature :
12. 12.1 Remarks of the Chairman & Principal :
DEEPAK NAYAK
PRINCIPAL
12.2 Signature
A.J. Institute of Dental Sciences, Kuntikana,
INFORMATION SHEET
This informed Consent form is for patients who are hospitalised in dialysis unit of AJ
HOSPITAL AND RESEARCH CENTRE Mangalore. The title of our research project is
There may be some words that you do not understand. Please ask me to stop as we go
through this information sheet and I will take time to explain. If you have questions later, you
can ask them to me or the staff. This informed Consent form is for patients who are
hospitalised in the dialysis unit of AJ SHETTY HOSPITAL AND RESEARCH CENTER
Mangalore. Your participation in this research is entirely voluntary. It is your choice whether
to participate or not. All the services you receive at this college will continue and nothing will
change, even if you choose not to participate in this research project.
By participating in this study you will not be at risk .There may not be any benefit for you but
your participation is likely to help us find the answer to the research question. There may not
be any benefit to the society at this stage of the research, but future generations are likely to
benefit. This research will not carry any monetary benefit to you. The information that we
collect from this research project will be kept confidential.
If you have any questions you may ask them now or later, even after the study has started. If
you wish to ask questions later, you may contact me as follows:
Dr. PREETHIKA GB
Postgraduate student
Department of Oral Medicine and Radiology
A.J. Institute of Dental Sciences
Kuntikana,Mangalore – 575004
Contact no: 9035305870
Email id: gbpreethika@gmail.com
This proposal is submitted for approval to A.J. Ethics Committee, which is a committee
whose task is to make sure that research participants are protected from harm. If you wish to
find out more about this committee,
Contact:
Dr.Vathsala
Professor and HOD
Department of Oral Medicine and Radiology
A.J.Instituteof Dental Sciences
Kuntikana,Mangalore -575004
Email id- vathsalablr@gmail.com
CERTIFICATE OF CONSENT
I have read the foregoing information, or it has been read to me. I have had the opportunity to
ask questions about it and any questions that I have asked have been answered to my
satisfaction.
Name of Participant
Contact number
Signature of Participant
Address
Date
If illiterate
I have witnessed the accurate reading of the consent form to the potential participant, and the
individual has had the opportunity to ask questions. I confirm that the individual has given
consent freely.
Contact number
Signature of Participant
Address
Date
Statement by the researcher/person taking consent
I have accurately read out the information sheet to the potential participant, and to the best of
my ability, in their own language. I have made sure that the participant understands the
procedure and research will be done.
I confirm that the participant was given an opportunity to ask questions about the study, and
all the questions asked by the participant have been answered correctly and to the best of my
ability.
I confirm that the individual has not been coerced into giving consent, and the consent has
been given freely and voluntarily.
KUNTIKANA, MANGALORE.
Patient data:
Name: Date:
Age: Op no:
Sex:
Occupation:
Address:
Contact number:
Chief complaint:
History of present illness:
Medical history:
Drug history:
Dental history
Personal history
Clinical examination:
Provisional diagnosis:
Investigation:
Blood investigation:
Final diagnosis:
CURRICULUM VITAE
# 8, staff quatrz,
A.J. Hospital campus
Dr. VATHSALA, MDS kuntikanan,,
Oral Medicine & Radiology Mangalore- 575004
E-mail ID: vathsalablr@g.mail.com Mobile : 9740061137
PERSONAL DETAILS:
Religion : Christian
PROFESSIONAL QUALIFICATIONS:
PROFESSIONAL EXPERIENCE:
SCIENTIFIC PURSUITS
In the Country:
-Thesis on BLOOOD FUCOSE LEVELS as a marker of Oral Cancer
PARTICIPATED IN:
-Fifth National Conference of Indian Academy of Oral Medicine 3 rd and 4th July 1993,
Madras
-Tenth National Conference of Indian Academy of Oral Medicine & Radiology ( 1st
Asia Pacific Symposium of Oral and Maxillo Facial Radiologists) 18 th, 19th and 20th
December 1998, Mangalore, India
CHANDRAHASA TRUST, soraba, shimoga Dist, Karnataka State. 12th & 13th
November 2000
Pediatric Basic Life Support 26th April 2005, Al-Sadiq Hospital, Damman, K.S.A.
Renal Faliure 4th January 2005, Al-Sadiq Hospital, Damman, K.S.A.
Head Injuries 3rd May 2005, Al-Sadiq Hospital, Damman, K.S.A.
Third Annual update on Dentistry and Oral Medicine ( Infection Control ) 7 th April
2005, College of Dentistry, king Faisal University, Dammam, K.S.A.
Dentistry Just for KIDDS June 16th 2005, Medical Services Organization, Saudi-
Aramco, Dammam, K.S.A.
The use of Nitrous Oxide analgesia in dental clinic by Dr. Anas Chapra. And Muco-
Gingival Therapy with Sub-Gingival Restorations by Dr. Rami Hassanein 28 th May
2006, Saudi Council of Health Specialities
Fourth Annual update on Dentistry and Oral Medicine, 6 th April 2006, College of
Dentistry, King Faisal University, Dammam K.S.A.
Cerec 3D CAD/CAM Basic Course 9th and 10th May 2006, Dento-plast Center,
Dammam, K.S.A.
PRO-TAPER Endodontics, 8th & 9th April 2007, Dento Plast Center Dammam, K.S.A.
LANGUAGE KNOWN
English, Kannada, Hindi, Tamil & Arabic (adequate for profession)
REFERENCES:
Dr. Ramananda Shetty, Principal, Govt. Dental College, Bangalore, Karnataka
Dr. Mohammad Faizuddin MDS, Professor and HOD, Dept. of Periodontia Ambedikar
Dental College, Bangalore, Karnataka
Place:
Date:
(DR. VATHSALA, MDS)
CURRICULUM VITAE OF THE POSTGRADUATE.
1. Name: Dr PREETHIKA GB
2. Gender: female
3. Date of birth: 24/10/1988
4. Nationality: Indian
5. Marital status: Unmarried.
6. Address: D/O B GANESH NAIK
Bedrala house
Po Box Darbe
Puttur DK 574202
7. Education:
Institutions : AB Shetty Memorial Institute Of Dental
Sciences College, Mangalore
8. Language skills:
Language Passive Spoken Written
English Written
Kannada Written
Hindi Written
Marati spoken
Tulu spoken
Malayalam spoken
2010-2011 One year of compulsory rotatory internship from A.B.Shetty Memorial Institute
of Dental Sciences, Mangalore
Signature
Date
CONSENT LETTER
From,
Dr. PREETHIKA GB
PG student
Mangalore.
1 October 2013
To,
Dept of NEPHROLOGY
Mangalore.
Respected Sir,
I Dr. PREETHIKA GB PG student in the Dept of Oral Medicine And Radiology is doing a RESEARCH on
‘ORAL MANIFESTATIONS AMONG CHRONIC RENAL FAILURE PATIENTS WITH AND
WITHOUT TYPE II DIABETES –ON HAEMODIALYSIS’ for my major dissertation.
Thanking you,
Yours obediently,
Dr. Preethika GB