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
|
|
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
|
|
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
|
|
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. |