| CTRI Number |
CTRI/2025/03/083601 [Registered on: 27/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of pain relief and infection control with negative pressure versus passive ultrasonic cleaning in the treatment of tooth infection- a randomized clinical study |
|
Scientific Title of Study
|
Comparative evaluation of post-operative pain and antimicrobial efficacy of negative pressure versus passive ultrasonic irrigation activation in symptomatic apical periodontitis - A randomized 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 HOD Department of Conservative Dentistry and Endodontics |
| Affiliation |
Department of Conservative Dentistry and Endodontics M A Rangoonwala Dental College and Hospital |
| Address |
Room No 305 Department of Conservative Dentistry and
Endodontics M A Rangoonwala Dental College and Hospital Azam Campus 2390 KB Hidayatullah Road Camp Pune Maharashtra
Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9822055434 |
| Fax |
|
| Email |
drvivekhegde@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kunal Bagade |
| Designation |
PG Student |
| Affiliation |
M A Rangoonwala Dental College and Hospital |
| Address |
Room No 305 Department of Conservative Dentistry and
Endodontics M A Rangoonwala Dental College and Hospital Azam Campus 2390 KB Hidayatullah Road Camp Pune Maharashtra
Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
7843060996 |
| Fax |
|
| Email |
bagade.kunal111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kunal Bagade |
| Designation |
PG Student |
| Affiliation |
M A Rangoonwala Dental College and Hospital |
| Address |
Room No 305 Department of Conservative Dentistry and
Endodontics M A Rangoonwala Dental College and Hospital Azam Campus 2390 KB Hidayatullah Road Camp Pune Maharashtra
Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
7843060996 |
| Fax |
|
| Email |
bagade.kunal111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room number 305 Department of Conservative Dentistry and Endodontics M A Rangoonwala Dental College and Hospital Azam Campus 2390 KB Hidayatullah Road Camp Pune Maharashtra 411001 India |
|
|
Primary Sponsor
|
| Name |
Dr Vivek Hegde |
| Address |
Room number 305 Department of Conservative Dentistry and Endodontics M A Rangoonwala Dental College and Hospital Azam Campus 2390
KB Hidayatullah Road Camp Pune Maharashtra 411001 India |
| 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 Vivek Hegde |
M A Rangoonwala Dental College and Hospital |
Room No 305
Department of
Conservative Dentistry
and Endodontics Azam
Campus 2390 KB
Hidayatullah Road
Camp
Pune
MAHARASHTRA |
9822055434
drvivekhegde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MCE 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: K045||Chronic apical periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Negative pressure irrigation activation (Pulp Sucker system) |
root canal irrigation will be performed using the pulp sucker system and antimicrobial load will be assessed after access opening and final irrigation and pain levels will be evaluated at 24 hours 48 hours and 72 hours |
| Comparator Agent |
Conventional needle irrigation ( Side-vented needle ) |
root canal irrigation will be performed using side vented needle and antimicrobial load will be assessed after access opening and final irrigation and pain levels will be evaluated at 24 hours 48 hours and 72 hours |
| Intervention |
Manual dynamic agitation activation |
root canal irrigation will be performed using manual dynamic agitation activation and antimicrobial load will be assessed after access opening and final irrigation and pain levels will be evaluated at 24 hours 48 hours and 72 hours |
| Intervention |
Passive ultrasonic irrigation activation ( XP endo finisher )
|
root canal irrigation will be performed using passive ultrasonic irrigation activation and antimicrobial load will be assessed after access opening and final irrigation and pain levels will be evaluated at 24 hours 48 hours and 72 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients with chronic irreversible pulpitis with symptomatic apical
periodontitis indicated for endodontic treatment
PAI score or Periapical Index Score less than or equal to 3 (Dag Orstavik)
Mandibular Premolars with a single root and a single canal
Patients having no significant systemic conditions
Patients who are ready to give written informed consent
|
|
| ExclusionCriteria |
| Details |
Teeth with sinus drainage
Fractured tooth
Teeth with root resorption
Non restorable and periodontally compromised teeth
Re-treatment cases
Patients who received analgesics or antibiotics within the preceding 12 hours before the procedure
Pregnant and lactating women
Patients having severe malocclusion associated with a traumatic occlusion
Teeth with calcified canals
Teeth with an open apex
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare antimicrobial efficacy following irrigation
activation using Pulpsucker system, XP Endo finisher, Manual dynamic
agitation and Conventional needle during root canal therapy |
baseline and after final irrigation on first appointment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare post-operative pain following irrigation
activation using Pulpsucker system, XP Endo finisher, Manual dynamic
agitation and Conventional needle during root canal therapy |
24 hours.
48 hours. 72 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
|
N/A |
|
Date of First Enrollment (India)
|
13/04/2025 |
| 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
|
This study explores the effectiveness of different irrigation techniques in reducing post-operative pain and microbial load in patients with symptomatic apical periodontitis. It compares four methods: negative pressure irrigation (Pulpsucker system), passive ultrasonic irrigation (XP-Endo Finisher), manual dynamic agitation, and conventional needle irrigation. It aims to highlight the benefits of modern techniques in improving root canal treatment outcomes. |