| CTRI Number |
CTRI/2024/08/073074 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
28/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Analysis of Various Irrigants on Substance P Expression in Single-Visit Root Canal Treatment for Teeth with Irreversible Pulpitis |
|
Scientific Title of Study
|
Comparative Evaluation Of Different Irrigants On Substance P Expression For Single Visit Root Canal Treatment Of Teeth With Irreversible Pulpitis - A Double Blinded Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lubna Hassan |
| Designation |
MDS Student Of Conservative Dentistry And Endodontics |
| Affiliation |
I.T.S Center For dental Studies And Research Center |
| Address |
Room no 6, PG Clinic,Department of Conservative Dentistry and Endodontics,I.T.S Centre For Dental Studies And Research,Delhi-Meerut Road,Muradnagar,Ghaziabad
UTTAR PRADESH
India
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
7464950576 |
| Fax |
|
| Email |
jannat.hassan5100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonali Taneja |
| Designation |
Professor, HOD, Dean-PG STUDIES |
| Affiliation |
I.T.S Centre For Dental Studies And Research, |
| Address |
Department of conservative Dentistry and Endodontics, I.T.S Centre For Dental Studies and Research, Delhi-Meerut Road, Muradnagar, Ghaziabad
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
9891688100 |
| Fax |
|
| Email |
sonalitaneja@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Taneja |
| Designation |
Professor, HOD, Dean-PG STUDIES |
| Affiliation |
I.T.S Centre For Dental Studies And Research |
| Address |
Department of Conservative Dentistry and Endodontics, I.T.S Centre for Dental Studies and Research, Delhi-Meerut Road, Muradnagar, Ghaziabad
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
9891688100 |
| Fax |
|
| Email |
sonalitaneja@its.edu.in |
|
|
Source of Monetary or Material Support
|
| I.T.S CENTRE FOR DENTAL STUDIES AND RESEARCH
MURADNAGAR, GHAZIABAD-201206 INDIA |
|
|
Primary Sponsor
|
| Name |
Dr Lubn Hassan |
| Address |
Room No. A-103, PG Girls Hostel, I.T.S Dental College, Muradnagar, Ghaziabad, 201206, INDIA |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| LUBNA HASSAN |
I.T.S Center for dental studies and research center |
Room No. 6 Department of Conservative Dentistry and Endodontics.
Ghaziabad
UTTAR PRADESH |
7464950576
jannat.hassan5100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| I.T.S Center for dental studies and research center, Muradnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Irrigant solution |
5ml of irrigant Administered intracanal for 1 minute after every preparation
|
| Comparator Agent |
Irrigating Solution |
5.25% SODIUM HYPOCHLROITE, ketorolac tromethamine
100% moringa oleifera
50% azadirachta indica |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient must be prsent with pain due to irreversible pulpitis from carious teeth requiring root canal treatment. |
|
| ExclusionCriteria |
| Details |
No periapical bone changes on the pre-operative radiograph
Any variation in the root canal anatomy and patient not willing to sign the informed consent. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1-post-operative pain
|
1-after 24 hours of initiation of the treatment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| substance P expression |
after 2 months of treatment initiation |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
10/09/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Endodontic treatment plays a vital role in
managing pulpal and peri-radicular infections caused by a diverse array of microorganisms present in the root canal. The success of endodontic treatment is
contingent upon the proper execution of key procedures, including biomechanical
preparation, irrigation, and root canal obturation.The adoption of single-visit root canal
treatment is gaining popularity in certain endodontic practices. Nonetheless, a
significant apprehension associated with this approach is the concern for
post-operative pain. Neuropeptides are bioactive peptides
predominantly produced in neurons. Substance P, identified as the first
neuropeptide in dental tissues, plays a crucial role in influencing blood flow,
inflammatory processes, and immune responses. Ketorolac tromethamine, a potent nonsteroidal
anti-inflammatory drug (NSAID), is available in both oral and injectable forms. Sodium hypochlorite (NaOCl) stands as the gold
standard and the most frequently utilized root canal irrigant, primarily owing
to its notable antimicrobial activity, effectiveness against biofilms, and
capacity to dissolve soft tissues. However, it exhibits certain undesirable
characteristics, including its potential to irritate periapical tissues even at
low concentrations, particularly when extruded beyond the apex in teeth with an
open apex and nonvital pulps. However, herbal and natural products have become
a focal point of research globally in recent years due to their medicinal
properties.Neem (Azadirachta indica), also known as the
margosa tree, is a natural product gaining attention in endodontic research. Moringa oleifera, a tree indigenous to India and
a member of the Moringaceae family, is colloquially known as the
"drumstick" or "horseradish" tree. The leaves of M. oleifera are abundant in
flavonoids and phenolic compounds, showcasing significant antioxidant and
anti-inflammatory properties. |