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CTRI Number  CTRI/2026/03/106041 [Registered on: 12/03/2026] Trial Registered Prospectively
Last Modified On: 10/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Analysis of effect of Dexamethasone administered via different routes on post operative pain in root canal treatment. 
Scientific Title of Study   Comparative evaluation of effect of Dexamethasone via different routes on post BMP pain in patients with apical periodontitis- A randomized placebo-controlled trial 
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 Lavanya Prakash 
Designation  MDS (Postgraduate student)  
Affiliation  I.T.S. DENTAL COLLEGE, GREATER NOIDA 
Address  Room no.7, Department of Conservative dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Knowledge park 3, Greater Noida 47 Gautam Buddha Nagar UTTAR PRADESH 201310 India

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9082072401  
Fax    
Email  lavanya.mds24@its.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Rohit Kochhar 
Designation  Head Of Department and Professor 
Affiliation  I.T.S. DENTAL COLLEGE HOSPITAL, GREATER NOIDA 
Address  Room no.7, Department of Conservative dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Knowledge park 3, Greater Noida 47 Gautam Buddha Nagar UTTAR PRADESH 201310 India

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9810034451  
Fax    
Email  hod.cons.gn@its.edu.in   
 
Details of Contact Person
Public Query  
Name  Dr MANJU KUMARI  
Designation  Professor 
Affiliation  I.T.S. DENTAL COLLEGE HOSPITAL, GREATER NOIDA 
Address  Room no.7, Department of Conservative dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Knowledge park 3, Greater Noida 47 Gautam Buddha Nagar UTTAR PRADESH 201310 India

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9811056881  
Fax    
Email  manjukumari.dntl.gn@its.edu.in   
 
Source of Monetary or Material Support  
Room no.7, Department of Conservative dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Knowledge park 3, 201310, Greater Noida 47, uttar pradesh, india  
 
Primary Sponsor  
Name  ITS Dental College Hospital and Research Centre 
Address  Room no.7, Department of Conservative dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Knowledge park 3, Greater Noida 47, Uttar Pradesh, India  
Type of Sponsor  Research institution and hospital 
 
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 LAVANYA PRAKASH   I.T.S. DENTAL COLLEGE, GREATER NOIDA  Room no.7, Department of Conservative dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Knowledge park 3, Greater Noida 47 Gautam Buddha Nagar UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH 		 9082072401

lavanya.mds24@its.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
I.T.S Dental college hospital and research centre institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K045||Chronic apical periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexamethasone  Dexamethasone is a potent, long-acting corticosteroid used for its intense anti-inflammatory and immunosuppressant properties. 
Comparator Agent  Local Anesthesia   Lignocaine with adrenaline is the gold standard local anesthetic for dental infiltration due to its rapid onset 2–3 mins and intermediate action. It provides effective pain control for soft tissue procedures and restorative work 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  t with preoperative VAS score more than 5
Pt aged 20-40 years who are systemically healthy
Pt diagnosed with apical periodontitis needing endodontic therapy.
 
 
ExclusionCriteria 
Details  History of allergy to LA and any other drug used in the study
Pts who are medically compromised
Pts who have taken analgesics or steroids 24 hrs before reporting.
Retreatment cases, Calcified canals, Vertical Root fracture
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate effect of Dexamethasone via different routes on post BMP pain in pts with apical periodontitis.
 		 6 hour, 12 hour, 24 hour, 48 hour, 72 hour
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 4 
Date of First Enrollment (India)   23/03/2026 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 randomized placebo-controlled clinical trial aims to evaluate and compare the effectiveness of dexamethasone administered via different routes in reducing postoperative pain following biomechanical preparation in patients with apical periodontitis. Sixty systemically healthy patients aged 20 to 40 years with preoperative pain VAS  more than 5 will be randomly allocated into five groups: placebo calcium hydroxide with saline, calcium hydroxide mixed with dexamethasone, dexamethasone as an intracanal irrigant, dexamethasone as an adjunct with infiltration or block anesthesia, and dexamethasone via intraligamentary injection. Postoperative pain will be assessed using a Visual Analog Scale at 6, 12, 24, 48, and 72 hours. The study aims to determine whether the route of dexamethasone administration influences postoperative pain control following endodontic treatment in teeth with apical periodontitis. 
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