| CTRI Number |
CTRI/2025/09/094677 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of bacteria in teeth. |
|
Scientific Title of Study
|
Bacterial evaluation of teeth biofilm. |
| 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
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
Chennai
TAMIL NADU
600107
India |
| Phone |
8428867520 |
| Fax |
|
| Email |
k.bhuvaana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AR Pradeep kumar |
| 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
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
Chennai
TAMIL NADU
600107
India |
| Phone |
9840135711 |
| Fax |
|
| Email |
arpradeependo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AR Pradeep kumar |
| 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
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
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 |
Research institution and hospital |
|
|
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 |
| 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
Chennai
TAMIL NADU |
8428867520
k.bhuvaana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Biofilm from heathy teeth of
non-diabetic patients. |
Biofilm from heathy teeth of non-diabetic patients has been taken as control. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Caries active Patients with at least three active dentin carious lesions
2. caries-free subjects must have been free of carious lesions for a period of at least 2 years displaying a DMFT less than or equal to 3.
3.Diabetic patients Hba1c greater than or equal to 7.
|
|
| ExclusionCriteria |
| Details |
1.Systemic disease except diabetes
2.History of antibiotics / anti-inflammatory drug 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 active and caries free diabetic and non-diabetic patients. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of PH, urea, lactic acid of tooth biofilm and salivary PH, glucose level of caries active and caries free diabetic and non-diabetic patients. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
12/10/2025 |
| 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="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
|
The study aims to comprehensively assess the biochemical and microbial characteristics of the oral environment by analyzing plaque bacteria, PH, urea, lactic acid and salivary PH, glucose in diabetic and non-diabetic individuals stratified by caries status. The objective is to elucidate the relationships between parameters and caries risk, providing a foundation for personalized preventive strategies targeting oral acid-basis homeostasis. |