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CTRI Number  CTRI/2024/11/077149 [Registered on: 20/11/2024] Trial Registered Prospectively
Last Modified On: 23/01/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Potential diagnostic markers for patients with high blood sugar and tooth infection. 
Scientific Title of Study   Correlation of HbA1C and Gingival Crevicular Fluid Levels of NLRP3 in Type 2 Diabetes Mellitus Patients with Pulp Necrosis and Symptomatic Apical Periodontitis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pranay Kumar Singh 
Designation  BDS Undergraduate Student  
Affiliation  Manav Rachan Dental College 
Address  Department of Conservative Dentistry and Endodontics, Second floor, Q block, Room no. QS26, Manav Rachna Dental College, Sector – 43,Delhi, Suraj Kund Badkhal Rd, Faridabad, Haryana 121004 India

Faridabad
HARYANA
121004
India 
Phone  9210743330  
Fax    
Email  Pranayksingh21@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aakansha Puri 
Designation  Senior Lecturer 
Affiliation  Manav Rachna Dental College 
Address  Department of Conservative Dentistry and Endodontics, Second floor, Q block, Room no. QS26, Manav Rachna Dental College, Sector – 43,Delhi, Suraj Kund Badkhal Rd, Faridabad, Haryana 121004 India

Faridabad
HARYANA
121004
India 
Phone  9741164564  
Fax    
Email  aakanshapuri.sds@mrei.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Aakansha Puri 
Designation  Senior Lecturer 
Affiliation  Manav Rachna Dental College 
Address  Department of Conservative Dentistry and Endodontics, Second floor, Q block, Room no. QS26, Manav Rachna Dental College, Sector – 43,Delhi, Suraj Kund Badkhal Rd, Faridabad, Haryana 121004 India

Faridabad
HARYANA
121004
India 
Phone  9741164564  
Fax    
Email  aakanshapuri.sds@mrei.ac.in  
 
Source of Monetary or Material Support  
Manav Rachna Dental College, Delhi Surajkund Road, Faridabad, Haryana,121004 India 
 
Primary Sponsor  
Name  Pranay Kumar Singh 
Address  Department of Conservative Dentistry and Endodontics, Second floor, Q block, Room no. QS26, Manav Rachna Dental College, Sector – 43,Delhi, Suraj Kund Badkhal Rd, Faridabad, Haryana 121004 India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aakansha Puri  Manav Rachna Dental College  Department of Conservative Dentistry and Endodontics, Q Block Second Floor Room no. QS26, Manav Rachna Dental College, Sector 43,Delhi, Suraj Kund Badkhal Rd, Faridabad, Haryana
Faridabad
HARYANA 		 9741164564

aakanshapuri.sds@mrei.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Systemically healthy individuals with pulp necrosis and symptomatic apical periodontitis 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient with SAP in one molar tooth and Type 2 DM

2. Patients with SAP in one molar tooth and no systemic disease

3. Patients with no other systemic disease 
 
ExclusionCriteria 
Details  1. Pregnant or lactating patients
2. Patients with systemic disease other than Type 2 Diabetes Mellitus
3. Tooth with furcation involvement
4. Patients with uncontrolled diabetes Mellitus 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Difference in the levels of NLRP3 in Gingival Crevicular Fluid in the Type 2 Diabetes Mellitus patients with SAP in comparison to systemically healthy patients with SAP
 		 One week after the oral prophylaxis. 
 
Secondary Outcome  
Outcome  TimePoints 
Difference in the levels of HbA1c in the Type 2 Diabetes Mellitus patients with SAP in comparison to systemically healthy patients with SAP.  One week after the oral prophylaxis. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/11/2024 
Date of Study Completion (India) 16/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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 research aims to evaluate the difference in the serum HbA1c and Gingival Crevicular Fluid levels of NLRP3 in Type 2 Diabetes Mellitus patients with pulp necrosis and symptomatic apical periodontitis in comparison with systemically healthy patients diagnosed with pulp necrosis and symptomatic apical periodontitis. The study design is a Cross-sectional study. Sixty patients diagnosed with pulp necrosis and symptomatic apical periodontitis will be allotted into 2 groups of 30 each. One group will have pulp necrosis and symptomatic apical periodontitis along with overlying Type 2 Diabetes Mellitus. Group 2 will have systemically healthy patients with pulp necrosis and symptomatic apical periodontitis. The serum levels of HbA1c and gingival crevicular fluid levels of NLRP3 will be evaluated one week after oral prophylaxis. Null Hypothesis- There is no difference in the HbA1c levels and NLRP3 Gingival Crevicular Fluid levels of patients diagnosed with Type 2 Diabetes Mellitus patients and pulp necrosis along with Symptomatic apical Periodontitis in comparison to the systemically healthy patients diagnosed with pulp necrosis along with symptomatic apical periodontitis. 
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