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CTRI Number  CTRI/2021/04/032814 [Registered on: 13/04/2021] Trial Registered Prospectively
Last Modified On: 22/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Trunatomy file system and Manual dynamic irrigation agitation]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of rotary file systems and irrigation agitation techniques on post-operative pain after endodontic therapy in patients with symptomatic irreversible pulpitis teeth. 
Scientific Title of Study   The effect of novel rotary file systems along with irrigation agitation technique on postoperative pain in teeth with symptomatic irreversible pulpitis : a randomized clinical trail 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RAVURI VARSHINI MEGHANA 
Designation  POST GRADUATE 
Affiliation  Narayana Dental College and Hospital  
Address  Room no.4, first floor, Department of Conservative Dentistry and Endodontics, Narayana Dental College and Hospital, chinthareddypalem, Nellore

Nellore
ANDHRA PRADESH
524003
India 
Phone  9573673129  
Fax    
Email  varshini9ravuri@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kiranmayi Govula 
Designation  Associate Professor 
Affiliation  Narayana Dental College and Hospital  
Address  Room no.4, first floor, Department of Conservative Dentistry and Endodontics, Narayana Dental College and Hospital, chinthareddypalem, Nellore

Nellore
ANDHRA PRADESH
524003
India 
Phone  9440932608  
Fax    
Email  govulakiranmayi24@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Lavanya 
Designation  Professor and Head of the Department 
Affiliation  Narayana Dental College and Hospital  
Address  Room no.4, first floor, Department of Conservative Dentistry and Endodontics, Narayana Dental College and Hospital, chinthareddypalem, Nellore

Nellore
ANDHRA PRADESH
524003
India 
Phone  9346567413  
Fax    
Email  lavanyamds@gmail.com  
 
Source of Monetary or Material Support  
Narayana Dental College and Hospital, Chinthareddypalem, Nellore -524003, Andhra Pradesh. 
 
Primary Sponsor  
Name  Dr Ravuri Varshini Meghana 
Address  room no.4, first floor, Narayana Dental College and Hospital, chinthareddypalem, Nellore, Andhra Pradesh  
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 Ravuri Varshini Meghana  Narayana Dental College and Hospital  Room no.4, Department of Conservative Dentistry and Endodontics, Narayana Dental College and Hospital, chinthareddypalem, Nellore
Nellore
ANDHRA PRADESH 		 9573673129

varshini9ravuri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  participants who are suffering with symptomatic irreversible pulpitis teeth rendering root canal therapy 
Patients  (1) ICD-10 Condition: Z658||Other specified problems related to psychosocial circumstances,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Pro Taper gold rotary file systems along with Conventional irrigation technique  Instrumentation with Pro Taper gold rotary file systems (endodontic rotary file system) along with Conventional syringe irrigation technique 
Intervention  Trunatomy file system along with Manual dynamic irrigation agitation  Instrumentation with Trunatomy rotary file system(endodontic rotary file system) along with manual dynamic agitation with well fitting gutta percha cone. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients with symptomatic irreversible pulpitis in posterior teeth.
Healthy patients of age group between 18-50 yrs.
Patients with preoperative pain scores which will vary from moderate to severe pain on a visual analog scale(VAS).
Patients who will have the ability to understand and to use the pain scale
 
 
ExclusionCriteria 
Details  Patients with pain on percussion
Patients with traumatic occlusion, severe malocclusion
Teeth with calcified canals
Teeth with periapical radiolucency
Teeth with root resorption
Teeth with immature open apex
Patients with Re -RCT will be excluded.
• Patients who has taken analgesic or anti-inflammatory drugs within the last 12 hour
• Patients with known allergy to local anesthesia, sodium hypochlorite and chlorhexidine.
Presence of systemic diseases like cardiovascular disease, renal disease, bleeding disorders or any anti-coagulant use with in last month.
Pregnant and lactating mothers.
Patients who are unable or unwilling to complete the pain questionnaires.
Patients who are unwilling to sign consent for endodontic treatment
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of post-operative Pain scores using Visual Analog Scale   at 6,24,48,and 72 hours and on 7th day 
 
Secondary Outcome  
Outcome  TimePoints 
assessing quality of life using OHIP 14 criteria   at 72 hours 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/11/2021 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  post operative pain scores

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response (Others) -  timing and frequency of analgesic intake variables like gender, location, oral hygiene habits will be recorded and correlated using statistical analysis
  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response (Others) -  statistical analysis

  5. By what mechanism will data be made available?
    Response (Others) -  data will only be shared to the researchers untilunless requested for the purpose of systematic review and meta analysis

  6. For how long will this data be available start date provided 16-12-2022 and end date provided 16-12-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is a randomized, double blind, parallel group, single center trial in which we compare the effect of anatomical rotary and conventional rotary file systems along with manual dynamic agitation on post-operative pain in patients with symptomatic irreversible pulpitis will be assessed using Visual Analog Scale[VAS] at 6,24,48,and 72 hours and on 7th day. 
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