| CTRI Number |
CTRI/2024/03/064918 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
12/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the bacterial load and pain of 4 different types of irrigation activation systems in root canal treatment. |
|
Scientific Title of Study
|
A Comparative Evaluation Of Different Irrigation Activation Systems On Anti Microbial Load And Post Operative Pain In Symptomatic Apical Periodontitis: A Randomised Clinical 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 Vivek Hegde |
| Designation |
Professor and H O D Department of Conservative Dentistry and Endodontics |
| Affiliation |
M A Rangoonwala dental college and hospital azam campus pune |
| Address |
Room No 305 Department of Conservative Dentistry And Endodontics M A Rangoonwala Dental College and Hospital Azam Campus 2390 B K B Hidayatullah Road Camp Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9822055434 |
| Fax |
|
| Email |
drvivekhegde@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srilatha S |
| Designation |
Professor |
| Affiliation |
M A Rangoonwala dental college and hospital azam campus pune |
| Address |
Room No 305 Department Of Conservative Dentistry and Endodontics M A Rangoonwala Dental College And Hospital Azam Campus 2390 B K B Hidayatullah Road Camp Pune Maharashtra
Pune
MAHARASHTRA
411001
India |
| Phone |
9049397929 |
| Fax |
|
| Email |
drsri2005@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Taniya Katakwar |
| Designation |
PG student |
| Affiliation |
M A Rangoonwala dental college and hospital azam campus punens |
| Address |
Room No 305 Department Of Conservative Dentistry and Endodontics M A Rangoonwala Dental College And Hospital Azam Campus 2390 B K B Hidayatullah Road Camp Pune Maharashtra
Pune
MAHARASHTRA
411001
India |
| Phone |
8177954947 |
| Fax |
|
| Email |
tanya.katakwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| M A Rangoonwala Dental College and Hospital Room number 305 Department of Conservative Dentistry and Endodontics Azam Campus 2390 B K B Hidayatullah Road Camp Pune |
|
|
Primary Sponsor
|
| Name |
Dr Vivek Hegde |
| Address |
M A Rangoonwala Dental College and Hospital Azam Campus 2390 B K B Hidayatullah Road Camp Pune |
| 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 Srilatha S |
M A Rangoonwala Dental College and Hospital |
Room number 305 Department of Conservative Dentistry and Endodontics Azam Campus 2930 B K B Hidayatullah Road Camp Pune
Pune
MAHARASHTRA |
9049397929
drsri2005@gamil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M C E societys M A Rangoonwala Dental College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
crcc irrigator |
root canal irrigation performed using crcc irrigator and evaluation of antimicrobial load after access opening and final irrigation and evaluation of pain after final irrigation 24 hours 48 hours |
| Intervention |
passive ultra sonic |
root canal irrigation performed using passive ultra sonic irrigator and evaluation of antimicrobial load after access opening and final irrigation and evaluation of pain after final irrigation 24 hours 48 hours |
| Comparator Agent |
side vented needle |
root canal irrigation performed using side vented needle and evaluation of antimicrobial load after access opening and final irrigation and evaluation of pain after final irrigation 24 hours 48 hours |
| Intervention |
Sonic activation
|
Root canal irrigation performed using sonic activation and evaluation of anti microbial load after access opening and final irrigation and evaluation of pain after final irrigation 24 hours 48 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Mandibular premolar with single root canal
Teeth with symptomatic apical periodontitis
Teeth with PAI score less than 2
Patient ready to give written informed consent
|
|
| ExclusionCriteria |
| Details |
Non restorable and periodontally compromised teeth
Teeth with calcification and resorption
Medically compromised patient
Patient with TMJ problem and reduced mouth opening
Pregnant and lactating women
Patient on antibiotic and steroid therapy |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and evaluate the antimicrobial load following activation with side vented needle sonic activation passive ultrasonic and CRCC during root canal therapy |
after access opening
after final irrigation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare and evaluate post operative pain following activation with side vented needle sonic activation passive ultrasonic irrigation and CRCC irrigation during root canal therapy |
baseline 24 hours 48 hours |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 4 |
|
Date of First Enrollment (India)
|
08/04/2024 |
| 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="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
|
The current study aims to compare anti microbial load by using four irrigation activation methods side vented needles sonic activation passive ultrasonic activation and CRCC irrigation during root canal therapy.The samples will be collected after access opening and final irrigation. Pain will then be evaluate using visual analog scale after final irrigation 24 hours 48 hours. |