| CTRI Number |
CTRI/2025/02/081134 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
26/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare the antimicrobial ability of Ozonated Olive Oil, Iodine Potassium Iodide and Sodium Hypochlorite solutions with and without activation of solutions |
|
Scientific Title of Study
|
Comparison of antimicrobial efficacy of
Ozonated Olive Oil, Iodine Potassium
Iodide and Sodium Hypochlorite in primary
endodontic infection with and without
Passive Ultrasonic Irrigation- an In Vivo
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 Palak Chhaya |
| Designation |
PG student |
| Affiliation |
Narsinhbhai Patel Dental College And Hospital |
| Address |
S P Sahakar Vidyadham Ambaji Gandhinagar Link Road Room Number 5 Department Of Conservative Dentistry And Endodontics Narsinhbhai Dental College And Hospital Snakalchand Patel University
Mahesana
GUJARAT
382440
India |
| Phone |
7567123117 |
| Fax |
|
| Email |
pchhaya1798@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kailash Attur |
| Designation |
Professor and head |
| Affiliation |
Narsinhbhai Patel Dental College And Hospital |
| Address |
Room No 5 Department of conservative dentistry and endodontics Narsinhbhai Patel Dental College And Hospital Snakalchand Patel University Visnagar Mehsana
Mahesana
GUJARAT
384315
India |
| Phone |
9727752499 |
| Fax |
|
| Email |
atturkailash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kailash Attur |
| Designation |
Professor and head |
| Affiliation |
Narsinhbhai Patel Dental College And Hospital |
| Address |
Room No 5 Department of conservative dentistry and endodontics Narsinhbhai Patel Dental College And Hospital Snakalchand Patel University Visnagar Mehsana
Mahesana
GUJARAT
384315
India |
| Phone |
9727752499 |
| Fax |
|
| Email |
atturkailash@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of conservative dentistry and endodontics Narsinhbhai Patel Dental College And Hospital Visnagar Gujarat India 384315 |
|
|
Primary Sponsor
|
| Name |
Dr Palak Chhaya |
| Address |
301 Shiv Darshan Apartment Near Gokul Bunglow Park Colony Janmagar Gujarat India 361008 |
| Type of Sponsor |
Other [Self] |
|
|
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 PALAK CHHAYA |
Narsinhbhai Patel Dental College and Hospital |
Room number 5 Department of Conservative Dentistry and Endodontics SPU campus visnagar
Mahesana
GUJARAT |
7567123117
pchhaya1798@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Narshinbhai patel dental college Visnagar |
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 |
Antimicrobial Efficacy |
To evaluate antimicrobial efficacy of three irrigating solutions |
| Comparator Agent |
With and without Passive Ultrasonic Irrigation |
To evaluate the antimicrobial efficacy of the irrigants with and without Passive Ultrasonic Activation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Tooth with single root and single canal
Tooth Without any previous restorations
Tooth with necrotic pulp |
|
| ExclusionCriteria |
| Details |
Patient requiring antimicrobial premedication
Tooth with necrotic pulp
Tooth with cracks
Periapical cyst
Tooth with sinus tract |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| The antimicrobial efficacy would be higher with Passive Ultrasonic Irrigation Activation |
It would be checked at baseline 0 minute and after 1 minute of Passive Ultrasonic Irrigation Activation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The antimicrobial activity of Sodium Hypochlorite with Passive Ultrasonic Irrigation Activation would be higher |
It would be checked at baseline 0 minut & after 1 minute of Passive Ultrasonic Irrigation Activation |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/03/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Total sixty samples will be participating and will be divided into three group and will be further divided into six sub groups Group A 3 percent Sodium Hypochloride Subgroup A1 With Passive Ultrasonic Irrigation Activation Subgroup A2 Without Passive Ultrasonic Irrigation Activation Group B 2 percent Iodine Potassium Iodide Subgroup B1 With Passive Ultrasonic Irrigation Activation Subgroup B2 Without Passive Ultrasonic Irrigation Activation Group C Ozonated Olive Oil Subgroup C1 With Passive Ultrasonic Irrigation Activation Subgroup C2 Without Passive Ultrasonic Irrigation Activation |