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CTRI Number  CTRI/2024/10/074548 [Registered on: 01/10/2024] Trial Registered Prospectively
Last Modified On: 14/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Pain after single visit and multiple visit root canal treatment 
Scientific Title of Study   Incidence of post operative pain after single and multiple-visit Root Canal Treatment in teeth with vital and non-vital pulp - A randomized clinical 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  Swapnali Sutar 
Designation  PG Student 
Affiliation  Bharati Vidyapeeth (Deemed to be University) dental college and hospital. Pune 
Address  Depart of conservative dentistry and endodontics,Room no. 104, Bharati Vidyapeeth (Deemed to be University) dental college and hospital. Katraj Ambegaon BK road, Dhankawadi, Pune, Maharashtra. 411043

Pune
MAHARASHTRA
411043
India 
Phone  9972295201  
Fax    
Email  sutarswapnali1109@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jyoti Mandlik 
Designation  Professor 
Affiliation  Bharati Vidyapeeth (Deemed to be university) dental college and hospital. Pune 
Address  Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital. Pune

Pune
MAHARASHTRA
411043
India 
Phone  9421385056  
Fax    
Email  jyoti.mandlik@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query  
Name  Dr Jyoti Mandlik 
Designation  Professor 
Affiliation  Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital. Pune 
Address  Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital. Pune

Pune
MAHARASHTRA
411043
India 
Phone  9421385056  
Fax    
Email  jyoti.mandlik@bharatividyapeeth.edu  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital. Pune 
 
Primary Sponsor  
Name  Swapnali Sutar 
Address  Department of Conservative dentistry and Endodontics, Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital. Katraj - Ambegaon BK road, Dhankawadi, Pune, Maharashtra . 411043  
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 Swapnali Sutar  Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital. Pune  Department of Conservative Dentistry and Endodontics, Room no 104, Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Katraj Ambegaon BK road, Dhankawadi, Pune, Maharashtra 411043
Pune
MAHARASHTRA 		 9972295201

sutarswapnali1109@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital. Pune Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M275||Periradicular pathology associatedwith previous endodontic treatment,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A - Single visit root canal treatment  Patients will undergo single visit root canal treatment 
Comparator Agent  Group B - multiple visit root canal treatment  patients will undergo multiple visit root canal treatment 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1) Patients requiring Root Canal Treatment in single rooted single canaled teeth.
2) Patients between 18 – 50 years of age.
3) Teeth with completely formed apices. 
 
ExclusionCriteria 
Details  1) Teeth with Calcified canals.
2) Patients with non restorable and periodontally compromised teeth.
3) Pregnant patients and patients in lactating period.
4) Immunocompromised patients and those with complicating systemic diseases. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1 Post Operative pain  24 hrs, 48 hrs, 7 days
 
 
Secondary Outcome  
Outcome  TimePoints 
Intensity of post obturation pain via visual analogue scale  24 hrs, 48 hrs. 7 days 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
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)   01/10/2024 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Aim - To evaluate the incidence of post operative pain after single and multiple visit root canal treatment in teeth with vital and non vital pulp.
220 patients requiring root canal treatment will be randomly divided into two groups of 110 each Group A and Group B. Group A will undergo single visit root canal treatment and Group B will undergo multiple visit root canal treatment. Visual analogue scale will be used to measure postoperative pain at 24 hrs, 48 hrs and 7 days.
 
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