RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
KARNATAKA, BANGALORE
ANNEXURE- II
PERFORMA FOR REGISTRATION OF SUBJECTS FOR
DISSERTATION
1 / NAME OF THE CANDIDATE &ADDRESS / Dr.VEDASHREE.S.GB101,KPWD QUARTERS,JEEVAN BHIMA NAGAR,BANGALORE
2 / NAME OF INSTITUTION / VOKKALIGARA SANGHA DENTAL COLLEGE & HOSPITAL, BANGALORE
3 / COURSE OF STUDY & SUBJECT / MASTER OF DENTAL SURGERY (M.D.S)
ORAL MEDICINE & RADIOLOGY
4 / DATE OF ADMISSION TO COURSE / JUNE 2011
5 / TITLE OF THE TOPIC / ‘‘A COMPARATIVE STUDY OF CANDIDA SPECIES IN DIABETICS, NONDIABETICS WITH DENTURE STOMATITIS AND CONTROL GROUP’’
6. BRIEF RESUME OF THE INTENDED WORK
6.1 NEED FOR STUDY
The oral cavity is a very complex environment and has a rich variety of species of Candida. C.albicans represents the most common causative agent of oral candidiasis, however, other species of Candida like C.glabrata, C.tropicalis, C.krusei and C.parapsilosis have been isolated with relative frequency from patients with denture stomatitis.
Oral candidiasis is a common opportunistic infection in diabetic patients. Presence of dentures in the oral cavity of diabetics can promote the candida colonization and results in higher incidence of oral and systemic candidiasis. C.albicans was most common isolated species in both diabetic and nondiabetics, but diabetic patients with dentures had more non albicans candida species than nondiabetics.
Oral candidiasis in the form of Candida-associated denture stomatitis, is a common disease in a large percentage of denture wearers. Yeast cells adhere and colonize oral surfaces including mucosa and acrylic dentures and have the ability to co-aggregate with oral bacteria.The prevalence of candida species significantly increases with the highest degree of inflammation and it plays a role in progression of DS.
Non albicans candida(NAC) species are emerging as both colonizers and pathogens due to their increased virulence factor mainly in immunocompromised hosts. Unfortunately these species are less susceptible to common antifungal drugs than C.albicans. This fact highlights the importance of controlling the oral colonization in diabetic group.
As Candida albicans and related species play a major role in initiating, maintaining, and aggravating denture stomatitis with diabetes having higher susceptibility for fungal infections, this study will help in species identification and subsequent treatment plan in controlling spread of fungal infection in denture wearing risk patients who are more susceptible due to their immunosuppression.
Hence the aim of this study is to assess the candida species in diabetic and non diabetic patients with denture stomatitis and control group.
6.2 REVIEW OF LITERATURE
A study was conducted by Sanita et al, to assess the candida species prevalence in well controlled type 2 diabetic patients with denture stomatitis, and concluded that candida albicans was the predominant species isolated, with C.tropicalis and C.glabrata demonstrating similar prevalence. The prevalence of C.albicans and C.tropicalis in denture stomatitis groups were significantly higher than control group. The prevalence of C.tropicalis significantly increased with the highest degree of inflammation.
A study was conducted by Lotfi-Kamran et al, to evaluate and compare Candida colonization in denture of diabetic patients and non-diabetic control group, and concluded that the higher density of isolated colonies was seen in diabetic group in compare with control group. C. Albicans was the most common isolated Candida species in both groups, though diabetic patients had more non-albicans Candida isolated compared to non-diabetic patients
A study was conducted by Cristina et al, to describe the isolation of Candida dubliniensis from a patient with denture stomatitis and to compare with the presence of yeasts in the oral cavities of denture wearers and concluded that Candida albicans was the predominant species (58.9%), followed by Candida tropicalis(15.1%), Candida guilliermondii (13.7%), Candida glabrata (9.6%), and Candida parapsilosis (2.7%) in denture wearers and denture stomatitis.
A study was conducted by Barbara et al,to describe the clinical appearance of Candida-associated denture stomatitis (DS)in subjects with type 2 diabetes (T2DM) and concluded that diffuse type of inflammation was associated with T2DM. Inadequately controlled diabetes with Candida-associated DS was linked to a high incidence of an extensive type of inflammation, oral complaints and associated conditions.
A study was conducted by Gorden et al, to assess the contribution of Candida biofilms to the etiology of denture stomatitis, and concluded that the formation of Candida biofilms in dentures may assist survival of fungal cells and contribute to the disease process in patients with denture stomatitis.
6.3 OBJECTIVES OF STUDY
A. To assess the candida species in diabetic patients with denture stomatitis.
B. To assess the candida species in non diabetics with denture stomatitis
C. To assess the candida species in denture wearing individuals without
diabetes and with healthy oral mucosa
D. To compare the candida species in diabetic and non diabetic patients with
denture stomatitis and with denture wearing individuals without diabetes with healthy oral mucosa.
7. MATERIALS AND METHODS
7.1. Source of data
20 Diabetic patients with denture stomatitis , 20 non diabetics with denture stomatitis and 20 denture wearing individuals without diabetes with healthy oral mucosa as controls will be selected from the department of Oral medicine and Radiology , V.S. Dental college and hospital, Bangalore.
7.2. Inclusion criteria-
A. Known diabetes mellitus patients diagnosed with denture stomatitis.
B. Non diabetic patients diagnosed with denture stomatitis.
C. Denture wearing individuals without diabetes and with healthy oral mucosa as control group
Criteria for classification of denture stomatitis (Newton’s classification) -
· 0 – Absence of palatal inflammation
· 1 (type I ) – Petechiae dispersed throughout all or any part of palatal mucosa in contact with the denture (localised simple inflammation)
· 2 (type II ) - Macular erythema without hyperplasia ( generalised simple inflammation)
· 3 (type III ) – Diffuse or generalised erythema with papillary hyperplasia ( inflammatory papillary hyperplasia)
7.3. Exclusion criteria –
1. Individuals who had received or were currently receiving treatment with antibiotics, antifungal, or steroids In the past 3 months.
2. Patients with other immunosuppressive diseases or cancer therapy (radiotherapy or chemotherapy)
3. Patients wearing the same denture for more than 30 years will be excluded.
7.4 PLACE OF STUDY:
Department of Oral Medicine and Radiology, V.S.D.C. and Hospital, Bangalore
Department of Microbiology, KIMS Hospital, Bangalore.
7.5 STUDY DESIGN:
Comparative study
7.6 STUDY DURATION:
1 ½ Year
7.7 STUDY SAMPLE
Purposive sampling
7.8 SAMPLE SIZE:
Cases: 20 Diabetic patients with denture stomatitis
20 Non diabetic patients with denture stomatitis
Controls: 20 denture wearing individuals without diabetes and with healthy oral mucosa
7.9 PROPOSED STATISTICAL ANALYSIS
· 1-way analyses of variance followed by Tukey post hoc test
· Kruskal-wallis test followed by Dunns multiple comparisons test
· Fisher exact test and x² analysis.
7.10. Methods of collection of data and methodology:
(A) Initial examination: cases and controls which fulfil the clinical criteria will be considered for further study.
(B) Written consent will be obtained from patients.
(C) Personal, medical, and dental histories of the patients ( age, gender,medication use, habits and denture age ) will be recorded.
(D) Clinical examination of denture stomatitis done and classified based on the above mentioned criteria.
(E) Following this examination : collection of sample and identification of candida species
· Oral swab samples were collected from the tissue surface of the denture of all patients.
· Each swab will be placed into a test tube containing 5ml of 0.9% sterile saline solution and vortexed for 1 min to suspend the organisms from the swab.
· An aliquot (50µL) from this suspension spread –plated on chromagar and incubated at 30°for 5 days. Colonies will be presumptively identified by colony color.
· Biochemical test to confirm all identifications – one colony of each colour type on chromagar candida will be transferred onto fresh sabouraud dextrose agar for purity.
· After 48 hrs at 37°c,yeast isolates identified by carbohydrate assimilation pattern using APIID32C system, and morphologic characteristics produced on corn meal agar with tween-80.
· All the data obtained will be analyzed statistically.
7.11 DOES THESTUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTION TO BE CONDUCTED ON PATIENTS OR HUMANS OR ANIMALS? IF SO PLEASE DESCRIBE BRIEFLY
Yes
Oral swab samples will be collected from tissue surface of denture.
7.12 HAS THE ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION
YES.
8. LIST OF REFERENCES :
1.Paulavolpatosanita,Ana Claudia, Eunice teresinha ; candida spp. prevalence in well controlled type 2 diabetic patients with denture stomatitis, OOOOE 2011(6),111,726-33.
2.Mohammad HosseinLotfi-Kamran, Abbas Ali Jafari, Abbas Falah-Tafti; Candida Colonization on the Denture of Diabetic and Non-diabetic Patients, Dent Res J 2009; 6(1): 23-27
3.BarbaraDorocka-Bobkowska, DorotaZozulinska-Ziolkiewicz,BognaWierusz-Wysocka;Candida-associated denture stomatitis in type 2 diabetes mellitus, diabetes research and clinical practice , 2010(9) 81-86.
4.Cristina Marcos-Arias a, Jose´ Lo´pez Vicente b, Ismail H. Sahand; Isolation of Candida dubliniensis in denture stomatitis, Archives of oral biology 54(2009):127 – 131.
5.GordonRamage, Kelley Tomsett, Brian L. Wickes, Jose´ L. Lo´pez-Ribot,; Denture stomatitis: A role for Candida biofilms,OOOOE, 2004;98:53-9.
9 / Signature of candidate10 / Remarks of the guide
11 / Name and designation of
11.1 Guide
11.2 Signature
11.3 Co-guide
11.4 Signature
11.5 Head of the department
11.6 Signature / Dr. M. Manjunath ,MDS
Prof. and HOD,
Department of Oral Medicine and Radiology
Dr. Anjana Gopi, MD
Associate Professor
Department of Microbiology
KIMSH.
Dr. M. Manjunath, MDS
Prof. and HOD,
Department of Oral Medicine and Radiology
12 / 12.1 Remarks of the chairman and principal
12.2 Signature
CONSENT FORM
I______,son/daughter of ______, aged ______, resident of ______,being under the treatment of Dr.Vedashree.S.G do hereby give consent to the performance of drugs/ medical/ surgical/ anaesthesia/ diagnostic procedure upon me. The procedure has been explained to me in my own language and also the likely adverse effects of the drugs being used has been explained, I agree that no responsibility will be attached to the surgeon or the hospital staff.
Signature of witness Signature of the patient/guardian
Date –
Place - Signature of doctor