| CTRI Number |
CTRI/2019/09/021135 [Registered on: 09/09/2019] Trial Registered Prospectively |
| Last Modified On: |
27/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Effect of preparation size and taper on pain and healing after root canal treatment |
|
Scientific Title of Study
|
Effect of apical preparation size and taper on post operative pain and outcome of primary endodontic treatment:A prospective clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHAZRA FATIMA |
| Designation |
Post Graduate student |
| Affiliation |
Dr.Z.A.D.C |
| Address |
DEPT. OF CONSERVATIVE DENTISTRY & ENDODONTICS, Dr.Z.A.D.C, A.M.U, ALIGARH
DEPT. OF CONSERVATIVE DENTISTRY & ENDODONTICS, Dr.Z.A.D.C, A.M.U, ALIGARH
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
08439435025 |
| Fax |
|
| Email |
shazrafatima2008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ASHOK KUMAR |
| Designation |
PREFESSOR |
| Affiliation |
Dr.Z.A.D.C |
| Address |
DEPT. OF CONSERVATIVE DENTISTRY & ENDODONTICS, DR. Z.A.D.C, A.M.U, ALIGARH.
DEPT. OF CONSERVATIVE DENTISTRY & ENDODONTICS, DR. Z.A.D.C, A.M.U, ALIGARH.
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
09412732327 |
| Fax |
|
| Email |
ashokoperative@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
SHAZRA FATIMA |
| Designation |
Post Graduate student |
| Affiliation |
Dr.Z.A.D.C |
| Address |
DEPT. OF CONSERVATIVE DENTISTRY & ENDODONTICS, DR.Z.A.D.C, A.M.U, ALIGARH
DEPT. OF CONSERVATIVE DENTISTRY & ENDODONTICS, DR. Z.A.D.C, A.M.U, ALIGARH.
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
08439435025 |
| Fax |
|
| Email |
shazrafatima2008@gmail.com |
|
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Source of Monetary or Material Support
|
| Dr Ziauddin Ahmad Dental College & hospital, Aligarh Muslim Univeersity, Aligarh (202001), Uttar Pradesh. |
|
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Primary Sponsor
|
| Name |
Dr Ziauddin Ahmad Dental College |
| Address |
Aligarh Muslim University |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SHAZRA FATIMA |
A-1, THIRD FLOOR, AL-HAFEEZ APARTMENT, NEW S.S.NAGAR |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SHAZRA FATIMA |
Dr. Z.A.D.C, Aligarh Muslim University, Aligarh |
DEPT OF CONSERVATIVE DENTISTRY AND ENDODONTICS
Aligarh
UTTAR PRADESH |
08439435025
shazrafatima2008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commettee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Endodontic treatment |
Post-operative pain using VAS & healing using Periapical Index score on periapical radiographs will be compared among different groups. |
| Intervention |
Endodontic treatment |
Two groups - Group A (Apical enlargement - two sizes larger than first apical binding file)
Group B (Apical enlargement - three sizes larger than first apical binding file)
Subgroup A - Taper 4%
Subgroup B - Taper 6% |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Mandibular first molar with periapical radioluscency. |
|
| ExclusionCriteria |
| Details |
Patients who are pregnant
Patients who are uncontrolled diabetic
Patients who areimmunocompromised
Previously accessed root canal system with procedural errors |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of post operative pain and healing after preparation with different apical size and taper during primary endodontic therapy |
6hr, 12hr, 24hr, 36hr, 72hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Asessment of healing of periradicular tissues after primary endodontic treatment |
3 months, 6months,12 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
20/09/2019 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
Published in September 2021 in the Journal of Endodontics. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The apical third of the root canal is considered to be a critical zone because of presence of large number of ramifications and lateral canals in this region.Recognition of microorganisms in the apical region of root canal has led to the acceptance of enlargement of apical diameter that allows for better penetration of irrigants, thus, optimizing the root canal debridement and disinfection. However, the extent of this enlargement is still a debatable topic.The purpose of this study is to evaluate the effect of apical size
enlargement and taper on post-operative pain and the outcome of primary
endodontic treatment. The present study
will be prospective clinical study conducted in the Department of Conservative
dentistry and Endodontics, Dr. Ziauddin Ahmad Dental College and Hospital. The
study will involve two visit root canal treatment with different apical
enlargement size and taper of the file system used. Post-operative pain will be
evaluated using VAS scale and outcome will be evaluated based on periapical
index (PAI) scored on periapical radiograph.
|