| CTRI Number |
CTRI/2025/12/098546 [Registered on: 05/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of two methods of collection in detecting Candida albicans in diabetics and non diabetics having periodontitis and checking with their sugar levels. |
|
Scientific Title of Study
|
Comparative evaluation of oral candidal carriage from dorsum of tongue and subgingival area of diabetic patients with chronic periodontitis and non-diabetics with chronic periodontitis and correlating it with the glycemic levels. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Muskan Aggarwal |
| Designation |
Post graduate student |
| Affiliation |
Jss Academy of higher education and Research |
| Address |
Department of Periodontology,JSS Dental college and hospital, SS nagar, Bannimantap, Mysuru
Mysore
KARNATAKA
570015
India |
| Phone |
9878404510 |
| Fax |
|
| Email |
muskanaggarwal939@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sheela Kumar Gujjari |
| Designation |
Professor, Department of Periodontology |
| Affiliation |
Jss Academy of higher education and Research |
| Address |
Department of Periodontology, Jss dental college and hospital, Mysuru
Mysore
KARNATAKA
570015
India |
| Phone |
9878404510 |
| Fax |
|
| Email |
dr.sheelakumarg@jssuni.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DR Shivananda S. |
| Designation |
Reader, Department of oral and maxillofacial surgery |
| Affiliation |
Jss Academy of higher education and Research |
| Address |
Department of oral and maxillofacial surgery, Jss Dental college and hospotal, SS nagar, Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
9343322433 |
| Fax |
|
| Email |
dr.shivanandas@jssuni.edu.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research
V. Ramalingaswami Bhawan, P.O. Box No. 4911 · Ansari Nagar, New Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research ICMR |
| Address |
V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi - 110029 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Muskan Agarwal |
JSS Dental college and hospital, Mysuru |
Department of Periodontology- Room number-9
Mysore
KARNATAKA |
9878404510
muskanaggarwal939@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Dental Co lle ge & Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diabetic patients within age group 35-60 years with atleast three year duration of diabetes. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see which of the methods is is best to detect candida |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| If detection of candida depends on glycemic level pocket depth and duration of diabetes |
6 months |
|
|
Target Sample Size
|
Total Sample Size="152"
Sample Size from India="152"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This research aims to compare the prevalence of Candida species—particularly Candida albicans—on the dorsum of the tongue and in the subgingival area among diabetic patients with periodontitis and systemically healthy individuals with periodontitis in the Indian population. Since diabetics are more prone to fungal colonization and periodontal destruction due to altered immunity and microbiota, the study seeks to determine whether Candida is more abundant or differently distributed in these two oral sites. Understanding this distribution may clarify the potential role of Candida in the progression of chronic periodontitis, especially in immunocompromised patients. The findings could also help guide improved periodontal treatment strategies, including the possible use of adjunctive antifungal therapy or natural antimicrobial approaches. |