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CTRI Number  CTRI/2024/10/075462 [Registered on: 17/10/2024] Trial Registered Prospectively
Last Modified On: 23/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Effect of root canal treatment on blood sugar marker levels in pateints with Diabetes Mellius and periapiacal disease 
Scientific Title of Study   Effect Of Endodontic Treatment On The HbA1c And Gingival Crevicular Fluids Levels Of NLRP3 In Type 2 Diabetes Mellitus Patients With Pulp Necrosis And Symptomatic Apical Periodontitis – A Cross Sectional Study​ 
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 Dax Abraham 
Designation  Professor and Head of the Department of Conservative Dentistry and Endodontics 
Affiliation  Manav Rachna Dental College 
Address  Department of Conservative Dentistry and Endodontics, Second floor Q block, Room no, QS21 Manav Rachna Dental College Delhi Surajkund Road
Department of Conservative Dentistry and Endodontics, Second floor Q block, Room no, QS21 Manav Rachna Dental College Delhi Surajkund Road
Faridabad
HARYANA
121004
India 
Phone  9910433111  
Fax    
Email  daxabraham.sds@mrei.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Dax Abraham 
Designation  Professor and Head of the Department of Conservative Dentistry and Endodontics 
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
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
Faridabad
HARYANA
121004
India 
Phone  9910433111  
Fax    
Email  daxabraham.sds@mrei.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Dax Abraham 
Designation  Professor and Head of the Department of Conservative Dentistry and Endodontics 
Affiliation  Manav Rachna Dental College 
Address  Department of Conservative Dentistry and Endodontics Q block Room no. QS26, Manav Rachna Dental College, Sector – 43,Delhi, Suraj Kund Badkhal Rd, Faridabad, Haryana
Department of Conservative Dentistry and Endodontics Q block Room no. QS26, Manav Rachna Dental College, Sector – 43,Delhi, Suraj Kund Badkhal Rd, Faridabad, Haryana
Faridabad
HARYANA
121004
India 
Phone  9910433111  
Fax    
Email  daxabraham.sds@mrei.ac.in  
 
Source of Monetary or Material Support  
Manav Rachna International Institute of Research and Studies, Delhi Surajkund Road, Faridabad Haryana,121004 India 
 
Primary Sponsor  
Name  Manav Rachna Dental College 
Address  Manav Rachna International Institute of Research and Studies, Delhi Surajkund Road Faridabad, Haryana 121004 India 
Type of Sponsor  Research institution 
 
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 Dax Abraham  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 		 9910433111

daxabraham.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 
Comparator Agent  Symptomatic Apical Periodontitis with no overlying sytemic disease ( SAP)  Gingival Crevicular fluid samples and HbA1C bllod levels shall be analyzed before and after non surgical endodontic treatment. 
Intervention  Typ2 DM with Pulp necrosis and SAP  Gingicval Crevicular fluid levels and Hb1Ac blood levels shall be analyzed before and after non surgical endodontic treatment. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 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  Pregnant or lactating patients
Patients with systemic disease other than Type 2 Diabetes Mellitus
Tooth with furcation involvement
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 
Change in the levels of HbA1c and NLRP3 levels in Gingival Crevicular Fluid after non-surgical endodontic treatment.
 		 HbA1c blood levels shall be analyzed before endodontic treatment followed by 3 and 6 months after endodontic treatment
 
 
Secondary Outcome  
Outcome  TimePoints 
The HbA1c levels in serum shall also be evaluated after endodontic treatment   one week after completion of endodontic treatment 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/11/2024 
Date of Study Completion (India) 22/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="30" 
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 Effect of Endodontic treatment on the serum HbA1c and Gingival Crevicular Fluid levels of NLRP3 in Type 2 Diabetes Mellitus patients 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 the oral disease with overlying Type 2 Diabetes Mellitus. Group 2 will have systemically healthy patients with pulp necrosis and symptomatic apical periodontitis. Endodontic treatment will be done and serum levels of HbA1c and gingival crevicular fluid levels of NLRP3 will be evaluated one week post-treatment.  Null Hypothesis- There is no difference in the HbA1c levels and NLRP3 Gingival Crevicular Fluid levels of patients diagnosed with Symptomatic apical Periodontitis after Non-surgical endodontic treatment.


 
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