| CTRI Number |
CTRI/2022/04/041662 [Registered on: 05/04/2022] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Checking the pain caused after single visit root canal treatment using different types of instruments. |
|
Scientific Title of Study
|
Evaluation of post-instrumentation pain using three different rotary systems with and without activation of irrigation in single visit endodontics. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nishtha Kathiria |
| Designation |
Doctor, PhD Scholar, Professor |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital |
| Address |
Narsinhbhai Patel Dental College & Hospital
Sankalchand Patel Vidyadham
Ambaji Gandhinagar Link Road
Near Kamana Char Rasta
Visnagar
Mahesana
GUJARAT
384315
India |
| Phone |
09712994610 |
| Fax |
|
| Email |
dr.nkp.2557@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kailash Attur |
| Designation |
Doctor, Professor, HOD |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital |
| Address |
Narsinhbhai Patel Dental College & Hospital
Sankalchand Patel Vidyadham
Ambaji Gandhinagar Link Road
Near Kamana Char Rasta
Visnagar
Mahesana
GUJARAT
384315
India |
| Phone |
09727752499 |
| Fax |
|
| Email |
atturkailash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nishtha Kathiria |
| Designation |
Doctor, PhD Scholar, Professor |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital |
| Address |
Narsinhbhai Patel Dental College & Hospital
Sankalchand Patel Vidyadham
Ambaji Gandhinagar Link Road
Near Kamana Char Rasta
Visnagar
Mahesana
GUJARAT
384315
India |
| Phone |
09712994610 |
| Fax |
|
| Email |
dr.nkp.2557@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narsinhbhai Patel Dental college and Hospital, Visnagar, Mehasana |
|
|
Primary Sponsor
|
| Name |
Nishtha Kathiria |
| Address |
FF 1 Swapnil Avenue
Sardar Patel Colony
Near Sardar Patel Statue
Naranpura
Ahmedabad-380013 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Nishtha Kathiria |
Narsinhbhai Patel Dental College and Hospital |
Sankalchand Patel Vidhyadham
Ambaji Gandhinagar Link Road
Near Kamana Char Rasta
Visnagar-384315
Mahesana
GUJARAT |
09712994610
dr.nkp.2557@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe narsinhbhai patel dental college and hospital, Sankalchand Patel University, Visnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
irriversible pulpitis |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Post instrumentation pain |
To evaluate post instrumentation pain using different file systems with and without different irrigation protocol |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient within the age limit of 20-60 years requiring RCT.
Maxillary and mandibular 1st and 2nd molars.
Molars with Vertucci’s type 1 and 4 configuration only.
Periapical radiolucency, if present, not more than 2-3mm
Symptomatic and asymptomatic irreversible pulpitis.
Non-vital teeth with sinus tract.
|
|
| ExclusionCriteria |
| Details |
Patient with medical condition, pregnancy.
Patients under analgesics, antibiotics or non steroidal anti-inflammatory drugs for the past 1 month.
Presence of extra root or canals, severe curved canals, c-shaped canals
Cracked teeth.
Teeth with internal and external resorption, open apices
Patient with COVID-19 history of less than one month
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The amount of periapical debris extrusion does have an effect on causing post-endodontic pain. |
at 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The amount of periapical debris extrusion does have an effect on causing post-endodontic pain, with different file system at different time intervals. |
1st day, 2nd day, 3rd day and 7th day. |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "210"
Final Enrollment numbers achieved (India)="210" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
11/04/2022 |
| Date of Study Completion (India) |
11/12/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
11/12/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
| Understanding post-endodontic pain is of utmost importance and prevention and management of this pain is an integral part of endodontic treatment. Single visit root canal treatment for vital teeth has become a common practice and offers several advantages, including a reduced flare up rate, decreased number of operative procedures, and no risk of interappointment leakage through temporary restorations, convenience, patient acceptance and reduced post-operative pain and is less time consuming and more economical. | Literature shows that, one of the most important reasons for postoperative pain is the extrusion of debris at the apex during BMP. | Thus, to evaluate the correlation between newer file systems with and without activation of irrigating solution in single visit endodontic treatment. | | | |