| CTRI Number |
CTRI/2025/08/093200 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
17/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study on IL6 and TNFalpha in Painful Tooth Pulp and How These Inflammation Signals Differ in Diabetic and Non Diabetic People |
|
Scientific Title of Study
|
Differential Expression Of IL6 And TNF Alpha In Symptomatic Pulpitis A Comparative Study In Diabetic And Non Diabetic Individuals |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kanukurthi Meghana |
| Designation |
PG Student |
| Affiliation |
MNR Dental college and Hospital |
| Address |
Department of Conservative Denistry and Endodontics,
Room no 7
MNR Dental college and Hospital, MNR Nagar, Fasalwadi, Sangareddy
Depatment of Conservative Dentistry and Endodontics,
Room no 7
MNR Dental college and Hospital, MNR Nagar, Fasalwadi, Sangareddy
Medak
TELANGANA
502294
India |
| Phone |
8096153333 |
| Fax |
|
| Email |
kanukurthimeghana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.B.Vijetha |
| Designation |
Head of the Depatment ad Professor |
| Affiliation |
MNR Dental college and Hospital |
| Address |
room no 7,Department of conservative dentistry and endodontics, MNR Dental college and Hospital, MNR Nagar, Fasalwadi, Sangareddy
room no 7,Department of conservative dentistry and endodontics,MNR Dental college and Hospital, MNR Nagar, Fasalwadi, Sangareddy
Medak
TELANGANA
502294
India |
| Phone |
8096153333 |
| Fax |
|
| Email |
vijetha.mds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kanukurthi Meghana |
| Designation |
PG Student |
| Affiliation |
MNR Dental college and Hospital |
| Address |
room no 7,Department of conservative dentistry and endodontics, MNR Dental college and Hospital, MNR Nagar, Fasalwadi, Sangareddy
room no 7,Department of conservative dentistry and endodontics, MNR Dental college and Hospital, MNR Nagar, Fasalwadi, Sangareddy
Medak
TELANGANA
502294
India |
| Phone |
8096153333 |
| Fax |
|
| Email |
kanukurthimeghana@gmail.com |
|
|
Source of Monetary or Material Support
|
| MNR Dental College and Hospital, Fasalwadi, Sangareddy,Telangana |
|
|
Primary Sponsor
|
| Name |
Kanukurthi Meghana |
| Address |
MNR Dental College and Hospital, Fasalwadi, Sangareddy,Telangana. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| MNR dental college |
MNR Dental College and Hospital, Fasalwadi, Sangareddy,Telangana |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr B Vijetha |
MNR Dental college and Hospital |
Department of Conservative Denistry and Endodontics,
Room no 7
MNR Dental college and Hospital, MNR Nagar, Fasalwadi, Sangareddy
Medak
TELANGANA |
9160022422
vijetha.mds@gmail.com |
| Dr Kanukurthi Meghana |
MNR Dental College and Hospital |
Department of Conservative Denistry and Endodontics,
Room no 7
MNR Dental college and Hospital, MNR Nagar, Fasalwadi, Sangareddy
Medak
TELANGANA |
8096153333
kanukurthimeghana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MNR INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
IL 6 and TNF alpha |
nil |
| Intervention |
IL 6 and TNF aplha |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Medical Condition with Nondiabetic and type 2 Diabetic patients
2)Patients diagnosed with symptomatic pulpitis
3)Positive response to cold test
4)Teeth with adequate pulpal blood volume for biomarker analysis.
5)Willingness to Participate |
|
| ExclusionCriteria |
| Details |
1)Systemic Conditions Affecting Study Outcomes such as hyperparathyroidism, hyperthyroidism, hepatic or chronic renal disease.
2)Immunocompromised conditions
3)Pregnancy
4)Medication Use That Could Influence Inflammation levels
5)Negative response to cold test |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate levels of IL6 and TNF Alpha in type 2 diabetic and non diabetic pulpal blood. |
8 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
30/08/2025 |
| 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)
|
Open to Recruitment |
| 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 observational study aimed to compare the expression levels of pro-inflammatory cytokines Interleukin 6 and Tumor Necrosis Factor-alpha in patients with symptomatic pulpitis, focusing on differences between diabetic and nondiabetic individuals. A total of 70 patients will be enrolled and categorized based on their diabetic status. Pulpal samples were collected during routine endodontic access procedures, and cytokine levels were measured using enzyme-linked immunosorbent assay (ELISA). The study sought to assess the influence of systemic diabetic status on local pulpal inflammation. These findings highlight the potential impact of systemic metabolic conditions like diabetes on the progression and severity of pulpal disease. The study emphasizes the importance of considering systemic health in the diagnosis and management of endodontic infections |