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CTRI Number  CTRI/2015/02/005487 [Registered on: 02/02/2015] Trial Registered Prospectively
Last Modified On: 31/01/2015
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Pain evaluation after one time root canal treatment in patients with irreversible pulpitis using two different rotating instruments- A Randomised controlled trial. 
Scientific Title of Study   Postoperative pain evaluation in single-visit root canal treatment with Protaper next and MTwo rotary systems-A Randomised 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  DrTVSwathi 
Designation  post graduate student 
Affiliation  Narayana Dental College and Hospital 
Address  Narayana Dental college and Hospital post graduate student Dept of conservative dentistry and endodontics Chintareddy palem Nellore
Narayana Dental college and Hospital post graduate student Dept of conservative dentistry and endodontics Chintareddy palem Nellore
Nellore
ANDHRA PRADESH
524002
India 
Phone  9291259199  
Fax    
Email  tvs9891.wowie@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrKMadhusudhana 
Designation  Professor and HOD 
Affiliation  Narayana Dental College and Hospital 
Address  Narayana Dental college and Hospital Professor and HOD Dept of conservative dentistry and endodontics Chintareddy palem Nellore
Narayana Dental college and Hospital Professor and HOD Dept of conservative dentistry and endodontics Chintareddy palem Nellore
Nellore
ANDHRA PRADESH
524002
India 
Phone  9391046354  
Fax    
Email  drmadhuk15@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrSuneel Kumar Chinni 
Designation  Reader 
Affiliation  Narayana Dental College and Hospital 
Address  Narayana Dental college and Hospital Reader Dept of conservative dentistry and endodontics Chintareddy palem Nellore
Narayana Dental college and Hospital Reader Dept of conservative dentistry and endodontics Chintareddy palem Nellore
Nellore
ANDHRA PRADESH
524002
India 
Phone  9966313666  
Fax    
Email  chinnisk@yahoo.com  
 
Source of Monetary or Material Support  
Narayana Dental College and Hospital 
 
Primary Sponsor  
Name  Narayana Dental College and Hospital 
Address  Narayana Dental college and Hospital post graduate student Dept of conservative dentistry and endodontics Chintareddy palem Nellore 
Type of Sponsor  Other [Private Dental college 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 
DrTV Swathi  Narayana Dental College and Hospital  Narayana Dental College and Hospital First floor Room no 6 Dept of conservative dentistry and endodontics Chintareddypalem Nellore
Nellore
ANDHRA PRADESH 
9291259199

tvs9891.wowie@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Narayana Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients suffering with symptomatic irreversible pulpitis with deep caries lesion involving pulp,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  M Two rotary instruments  single visit root canal treatment Duration:60 to 90 minutes 
Comparator Agent  Protaper Next rotary instruments  single visit root canal treatment Duration:60 to 90 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.Single rooted teeth with irreversible pulpitis with normal periapical radiographic appearance
2.Prolonged response of pain even after the removal of stimulus
3.No signs of periapical lesion or radiolucency
4.patient who has ability to understand the use of pain scales will be provided informed consent for endodontic treatment 
 
ExclusionCriteria 
Details  1.patients with sinus tract, periapical abscess or facial cellulitis
2.patient with known allergies or any contraindication to opioid and non opioid analgesics
3.patients with known allergy to local anaesthesia sodium hypochlorite and chlorhexidine
4.presence of systemic diseases like cardio vascular disease, renal disease and any bleeding disorder within last month
5.pregnant and lactating mothers
6.patients who are unable to complete the pain questionnaries
7.patients who are unwilling to sign the informed consent 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
post operative pain evaluation using verbal descriptor scale  post operative pain evaluation using verbal descriptor scale at 8hrs,24hrs and 48hrs. 
 
Secondary Outcome  
Outcome  TimePoints 
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   N/A 
Date of First Enrollment (India)   02/03/2015 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  02/03/2015 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

          Root canal treatment is the removal of vital or necrotic pulp from the canal system of an infected tooth followed by replacement with an inert filling material.Traditionally,  root canal treatment  was performed in multiple visits, with medication between root canal preparation and obturation, which  aims to reduce or eliminate microorganisms and their by-products  before obturation.In recent times, there is a growing concern about the  multiple appointments as there is  no significant differences in antimicrobial efficacies have been reported between the single- and multiple-visit treatments . Furthermore, the recent invention of rotary  systems and improvements in the irrigation  delivery systems have facilitated the  better  instrumentation and disinfection of the root canal,  which inturn  makes the single-appointment treatment more convenient than before  along with other advantages like timesaving, better patient acceptance, and reduction of the interappointment infection risks,  reduced flare-ups (Walton & Fouad 1992, Imura & Zuolo 1995, Albashaireh & Alnegrish 1998). However the argument for single-visit treatment  still relies heavily on microbial eradication,postoperative pain, healing rate.  Numerous studies evaluated the effectiveness and post treatment pain of single- versus multiple-appointment root canal treatment and reported no significant difference in effectiveness (healing rates) and postoperative pain between these 2 treatment regimens. Sathorn et al conducted a metaanalysis in which he gave the conclusion that single-visit root canal treatment appeared to be slightly more effective than multiple visit, i.e. 6.3% higher healing rate.The aim of the present randomized controlled clinical trial is to evaluate the post-operative pain in patients underwent single visit root canal treatment with Mtwo and Protaper next rotary systems.

 

 
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