CTRI Number |
CTRI/2019/07/019960 [Registered on: 01/07/2019] Trial Registered Prospectively |
Last Modified On: |
26/06/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Pain evaluation with three different methods of working length taken |
Scientific Title of Study
|
Effect of three different methods of working length determination during root canal preparation on post operative pain - An in vivo study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Boris Saha |
Designation |
Post Graduate |
Affiliation |
Dr Z.Ahmad dental college and hospital |
Address |
Department of conservative dentistry.
Dr ziauddin ahmed dental college.
AMU , Aligarh
Aligarh UTTAR PRADESH 202001 India |
Phone |
09804427359 |
Fax |
|
Email |
borissaha@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Surendra kumar Mishra |
Designation |
Professor |
Affiliation |
Dr Z.Ahmad dental college and hospital |
Address |
Dr ziauddin ahmed dental college
AMU , aligarh
Aligarh UTTAR PRADESH 202001 India |
Phone |
09804427359 |
Fax |
|
Email |
drsurendrakmishra69@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Boris Saha |
Designation |
Post Graduate |
Affiliation |
Dr Ziauddin ahmed dental college and hospital |
Address |
Department of conservative dentistry and endodontics
Dr Ziauddin ahmed dental college
AMU , Aligarh
Aligarh UTTAR PRADESH 202001 India |
Phone |
09804427359 |
Fax |
|
Email |
borissaha@gmail.com |
|
Source of Monetary or Material Support
|
Department of conservative dentistry and endodontics
Dr Ziauddin ahmed dental college and hospital
AMU , Aligarh |
|
Primary Sponsor
|
Name |
Department of conservative dentistry and endodontics |
Address |
Dr Z. A dental college
aligarh muslim university
aligarh |
Type of Sponsor |
Government medical college |
|
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 Boris Saha |
Dr Ziauddin Ahmed dental college and hospital |
Department of conservative dentistry and endodontics Aligarh UTTAR PRADESH |
09804427359
borissaha@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional of ethics committee , facaulty of medicine , amu aligarh |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Electronic Apex Locator |
Endodontic treatment will be done , working length will be measured by using electronic apex locator |
Intervention |
Electronic Apex Locator with simultaneous root canal preparation |
Endodontic treatment will be done with endomotor which has inbuilt apex locator , therefore root canal preparartion will be done with simultaneous working length determination |
Comparator Agent |
Radiographic method of working length determination |
Endodontic treatment will be done with working length determination using radiographic method |
|
Inclusion Criteria
|
Age From |
12.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
Acute pain in single rooted tooth |
|
ExclusionCriteria |
Details |
Patient with systemic disease ,sinus tract , periapical lesion ,swelling and sinus tract , bruxism , severely damaged tooth and severe periodontal disease |
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Post operative pain |
pain evaluation at 24 hours, 48 hours and 72 hours |
|
Secondary Outcome
|
Outcome |
TimePoints |
Patients will be evaluated for need of post operative analgesics |
24 Hours
48 Hours
72 Hours |
|
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)
|
01/07/2019 |
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="0" Months="6" 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)?
|
Brief Summary
|
The
aim of the present study will be to clinically evaluate the post operative pain
during root canal preparation , with three different methods of working length
preparation. Suitable number of
patients will be selected for this in-vivo study . Single rooted tooth will be
taken into consideration for this study . Healthy young patients having
irrerversible pulpitis with tooth
positive to a percussion test , negative to palpation test and without any periapical lesion or any systemic
disease will be included in this study
Patients which will be
excluded from the study according to the following criteria: those with
systemic diseases, swelling, sinus tract, or preoperative palpation pain , those
having bruxism or clenching , a severely damaged tooth, severe periodontal
disease in related tooth or resorption in related tooth , having previously
undergone root canal treatment in related tooth.
A digital radiograph will
be used to confirm the presence of single root for the tooth to be operated on
. Preoperative pulpal diagnosis will be performed by both cold test and
Electric pulp test .Periapical diagnosis will be performed by periapical radiographs
and percussion and palpation tests .
Patients will be randomly
distributed into 3 experimental groups viz. Radiographic group, Electronic apex locator group and Simultaneous Prepared Group; with equal number of patients in each group. After the root canal preparations , patient will be evaluated for post
operative pain after 24hrs ,48 hrs & 72 hrs respectively , keeping in mind
no anaelgesics were given post-operatively before pain evaluation . Patient
will respond for pain after percussion on a designed visual analogue scale for
pain. |