| CTRI Number |
CTRI/2024/01/061896 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
19/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia
Diagnostic
Screening
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of irrigation systems on irrigant penetration in root canal treatment |
|
Scientific Title of Study
|
Comparative evaluation of different Irrigation methods on penetration of irrigant in the apical third of root canal – 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 |
Aditi Barmeda |
| Designation |
PG Student |
| Affiliation |
College of Dental Science and Research centre |
| Address |
Room no 7, 1st floor, Department of Conservative Dentistry and Endodontics, College of Dental Sciences and Research Centre, Manipur, Ghuma, Ahmedabad
Ahmadabad
GUJARAT
380058
India |
| Phone |
8238516133 |
| Fax |
|
| Email |
barmeda.aditi3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shilpa Shah |
| Designation |
Professor and PG Guide |
| Affiliation |
College of Dental Science and Research centre |
| Address |
Room no 7, 1st floor, Department of Conservative Dentistry and Endodontics, College of Dental Sciences and Research Centre, Manipur, Ghuma, Ahmedabad
Ahmadabad
GUJARAT
380058
India |
| Phone |
9376121229 |
| Fax |
|
| Email |
drshah16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditi Barmeda |
| Designation |
PG Student |
| Affiliation |
College of Dental Science and Research centre |
| Address |
Room no 7,1st floor, Department of Conservative Dentistry and Endodontics, College of Dental Sciences and Research Centre, Manipur, Ghuma, Ahmedabad
Ahmadabad
GUJARAT
380058
India |
| Phone |
8238516133 |
| Fax |
|
| Email |
barmeda.aditi3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics, College of Dental Sciences and Research Centre, Manipur, Ahmedabad |
|
|
Primary Sponsor
|
| Name |
Aditi Barmeda |
| Address |
Room no 7, Department of Conservative Dentistry and Endodontics, College of Dental Sciences and Research Centre, Manipur, Ahmedabad |
| 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 Aditi Barmeda |
College of Dental Sciences and Research Centre |
7,Department of Conservative Dentistry and Endodontics, College of Dental Sciences and Research Centre, Manipur, near Bopal, Ahmedabad
Ahmadabad
GUJARAT |
8238516133
barmeda.aditi3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, College of Dental Sciences and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K042||Pulp degeneration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Manual Dynamic Agitation |
Irrigation with 17% EDTA and 3% Sodium hypochlorite with master cone in up and down motions for 30 seconds at an approximate frequency of 100 times per minute |
| Comparator Agent |
Passive Ultrasonic Irrigation |
Irrigation with 17% EDTA and 3% Sodium hypochlorite with U files for 1 minute activation |
| Comparator Agent |
PATS Vario |
Irrigation with 17% EDTA and 3% Sodium hypochlorite using PATS Vario tip at frequency of 6k Hz for 1 min |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Teeth indicated for root canal treatment
Single rooted teeth with single straight canal
Adequate crown structure for isolation with rubber dam and post endodontic restoration |
|
| ExclusionCriteria |
| Details |
Non restorable teeth
Curved canals
Open Apex
Root resorption
Periodontally involved teeth with more than Grade 2 mobility
Patient having allergy to any component
Pregnant patients |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dye penetration in the root canal |
Baseline, 15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| More irrigant penetration with dynamic methods |
After Biomechanical Preparation |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
30/01/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Successful outcome of endodontic treatment is dependent on thorough removal of infected/necrotic pulp tissue, microorganisms and their toxin products. Mechanical instrumentation alone is ineffective in completely removing residual bacteria and necrotic debris. Even with the use of the nickel titanium rotary instruments currently available, they act only on the central body of the canal, leaving canal fins, isthmi and cul-de-sacs untouched after completion of the preparation central body of the canal, leaving canal fins, isthmi and cul-de-sacs untouched after completion of the preparation. Therefore, irrigation is an essential part of the root canal debridement because it allows for cleaning beyond what might not be achieved by root canal instrumentation alone. The penetration of the irrigant and the flushing action created by irrigation are dependent not only on the anatomy of the root canal system, but also on the system of delivery, the depth of placement, and the volume and fluid properties of the irrigant. The aim of this in vivo study is to evaluate the effect of different irrigation methods on irrigant penetration in the apical third of the root canal. |