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CTRI Number  CTRI/2019/05/019067 [Registered on: 13/05/2019] Trial Registered Prospectively
Last Modified On: 02/05/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Postoperative pain in one-visit versus two-visit root canal treatment 
Scientific Title of Study   "Incidence of postoperative pain after single visit and multiple visit root canal therapy: A Randomized Controlled Trial" 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nishi Kumari 
Designation  Post graduate student 
Affiliation  Affliated to Madhya Pradesh Medical Science University 
Address  Department of conservative and endodontics room no - 6 Hitkarini dental college and hospital Dumna road, jabalpur

Jabalpur
MADHYA PRADESH
482002
India 
Phone  8305565925  
Fax    
Email  nishionly1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S P Mantri 
Designation  Professor 
Affiliation  Affliated to Madhya Pradesh Medical Science University 
Address  Department of conservative and endodontic room no - 6 Hitkarini dental college and hospital Dumna road, jabalpur

Jabalpur
MADHYA PRADESH
482002
India 
Phone  9425832314  
Fax    
Email  shivmantri24@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr S P Mantri 
Designation  Professor 
Affiliation  Affliated to Madhya Pradesh Medical Science University 
Address  Department of conservative and endodontics room no - 6 Hitkarini dental college and hospital Dumna road, jabalpur

Jabalpur
MADHYA PRADESH
482002
India 
Phone  9425832314  
Fax    
Email  shivmantri24@gmail.com  
 
Source of Monetary or Material Support  
No material support 
 
Primary Sponsor  
Name  Dr Nishi Kumari 
Address  Hitkarini dental college and hospital dumna road, Jabalpur  
Type of Sponsor  Other [I am postgraduate student and I am funding myself for materials which will be used during my study. ] 
 
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 Nishi Kumari  Hitkarini dental college and hospital  Department of conservative and endodontics room no- 6 Hitkarini dental college and hospital Dumna road, jabalpur
Jabalpur
MADHYA PRADESH 
8305565925

nishionly1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Hitkarini dental college and hospital ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  IRREVERSIBLE PULPITIS OF MOLAR TOOTH 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Single visit and two visit  Procedure: single visit Endodontic treatment will be done and completed in a single visit using niti rotary system Procedure: two visit Endodontic treatment will be done and completed in two visits using niti rotary system 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.the patient should accept the proposed treatment with the criteria for postoperative pain evaluation
2.mandibular first molar
3.moderately curved root canals
4.both vital and non-vital teeth 
 
ExclusionCriteria 
Details  1.patients with any systemic disease
2.pregnant patients
3.patients who had been taking antibiotics, non-steroidal anti-inflammatory drugs or corticosteroids at the time of treatment
4.patients below 15 years and over 65 years
5.patients with acute periodontitis, acut apical abscess and weeping canals
6.retreatment cases
7.teeth with calcified canals
8.procedural errors
9.teeth with periapical radiolucency of diameter greater than 0.5cm
10.unusual canal morphology
11.teeth with extra root
12.patient who took antibiotics and/or analgesics right after the first appointment of the therapy 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Change of postoperative pain after 6-12-24-48 hours from Obturation step of endodontic treatment  Baseline, 6 hours, 12 hours, 24 hours and 48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Tenderness on percussion  After one week from obturation step of endodontic treatment 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   31/05/2019 
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="4"
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 - NO
Brief Summary   The purpose of this randomized clinical trial will be to evaluate the incidence and severity of postoperative pain after root canal treatment in mandibular first molar teeth in one appointment versus two appointments using niti rotary system.  
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