| CTRI Number |
CTRI/2025/08/093517 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
24/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate bacteria in decayed tooth of diabetic and non-diabetic patients. |
|
Scientific Title of Study
|
Evaluation of bacteria in caries biofilm of diabetic and non-diabetic patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhuvaneshwari K |
| Designation |
Post graduate student |
| Affiliation |
Thai Moogambigai Dental college and hospital. |
| Address |
402,3rd floor, Department of Conservative dentistry and
Endodontics,
Thai Moogambigai dental college and hospital,
Gangai amman koil street, Golden George nagar.
Chennai
TAMIL NADU
600107
India |
| Phone |
8428867520 |
| Fax |
|
| Email |
k.bhuvaana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AR Pradeepkumar |
| Designation |
Head of the department |
| Affiliation |
Thai Moogambigai Dental college and hospital |
| Address |
402,3rd floor, Department of Conservative dentistry and
Endodontics,
Thai Moogambigai dental college and hospital,
Gangai amman koil street, Golden George nagar.
Chennai
TAMIL NADU
600107
India |
| Phone |
9840135711 |
| Fax |
|
| Email |
arpradeependo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AR Pradeepkumar |
| Designation |
Head of the department |
| Affiliation |
Thai Moogambigai Dental college and hospital |
| Address |
402,3rd floor, Department of Conservative dentistry and
Endodontics,
Thai Moogambigai dental college and hospital,
Gangai amman koil street, Golden George nagar.
Chennai
TAMIL NADU
600107
India |
| Phone |
9840135711 |
| Fax |
|
| Email |
arpradeependo@gmail.com |
|
|
Source of Monetary or Material Support
|
| 402,3rd floor, Department of Conservative dentistry and
Endodontics,
Thai Moogambigai dental college and hospital,
Gangai amman koil street, Golden George nagar
Chennai
600107
TAMIL NADU
India |
|
|
Primary Sponsor
|
| Name |
Bhuvaneshwari k |
| Address |
402,3rd floor, Department of Conservative dentistry and Endodontics,
Thai Moogambigai dental college and hospital,
Gangai amman koil street, Golden George nagar.
Chennai
600107
TAMIL NADU
India |
| Type of Sponsor |
Other [(Self funded)] |
|
|
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 Bhuvaneshwari K |
Thai Moogambigai Dental college and hospital. |
402,3rd floor, Department of Conservative dentistry and Endodontics, Thai Moogambigai dental college and hospital, Gangai amman koil street, Golden George nagar
Chennai
600107
TAMIL NADU India
Chennai
TAMIL NADU |
8428867520
k.bhuvaana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics review board of Dr M.G.R Educational and Research Institute, University |
Approved |
| Institutional Ethics review board of Dr M.G.R Educational and Research Institute, University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Biofilm from heathy teeth of diabetic and non-diabetic patients. |
Biofilm from heathy teeth of diabetic and non-diabetic patients has been taken as a control. |
| Intervention |
Sucrose. |
10% of 10ml sucrose rinse for 1 minute. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Diabetic patients with active caries tooth and sound tooth structure.
2. Non diabetic patients with active caries tooth and sound tooth structure.
3. High caries index- DMFT greater than or equall to 3 |
|
| ExclusionCriteria |
| Details |
1. Other systemic diseases except diabetes mellitus.
2. History of antibiotics and anti-inflammatory drugs within preceding two weeks prior to the study.
3. History of fluoride treatment within preceding month prior to the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of bacteria in caries biofilm of diabetic and non-diabetic patients. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of bacteria in caries biofilm of diabetic & non-diabetic patients. |
Baseline
|
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/10/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
AIM - Evaluation of bacteria in caries biofilm of diabetic and non-diabetic patients before and after sucrose exposure.This study was done to analyze the impact of 10ml of 10% sucrose to evaluate the changes in the supragingival microbial communities in healthy and caries plaque of diabetic and non-diabetic patients
|