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
|
|
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
|
|
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
|
|
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. |