| CTRI Number |
CTRI/2025/06/089280 [Registered on: 20/06/2025] Trial Registered Prospectively |
| Last Modified On: |
26/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of pain after using different irrigating solution with activation |
|
Scientific Title of Study
|
Comparative evaluation of Post operative pain after using different root canal irrigants with irrigation activation techniques: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 Soumallya Hazra |
| Designation |
Pg Student |
| Affiliation |
College Of Dental Sciences And Research Center |
| Address |
Department of Conservative Dentistry and Endodontics
College Of Dental Sciences And Research Centre Manipur Ghuma
Ahmedabad
Ahmadabad
GUJARAT
382115
India
College of Dental Sciences & Research Centre Opp. Pleasure Club Near Navneet Printing Press Bopal Ghuma Manipur Ahmedabad 382115
Ahmadabad
GUJARAT
382115
India |
| Phone |
7990185880 |
| Fax |
|
| Email |
soumallyahazra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishtha Patel |
| Designation |
Professor and Pg Guide |
| Affiliation |
College Of Dental Sciences And Research Center |
| Address |
Department of Conservative Dentistry and Endodontics,
College Of Dental Sciences And Research Center, Manipur, Ghuma,
Ahmedabad
Ahmadabad
GUJARAT
College of Dental Sciences & Research Centre Opp. Pleasure Club Near Navneet Printing Press Bopal Ghuma Manipur Ahmedabad 382115
Ahmadabad
GUJARAT
382115
India |
| Phone |
9712994610 |
| Fax |
|
| Email |
dr.nkp.2557@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soumallya Hazra |
| Designation |
Pg Student |
| Affiliation |
College Of Dental Sciences And Research Center |
| Address |
Department of Conservative Dentistry and Endodontics,
College Of Dental Sciences And Research Center, Manipur, Ghuma,
Ahmedabad
Ahmadabad
GUJARAT
College of Dental Sciences & Research Centre Opp. Pleasure Club Near Navneet Printing Press Bopal Ghuma Manipur Ahmedabad 382115
Ahmadabad
GUJARAT
382115
India |
| Phone |
7990185880 |
| Fax |
|
| Email |
soumallyahazra@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Dental Science and Research Centre, Bopal, Ahmedabad |
|
|
Primary Sponsor
|
| Name |
Dr Soumallya Hazra |
| Address |
Department of Conservative Dentistry and Endodontics,
College Of Dental Sciences And Research Center, Manipur, Ghuma,
Ahmedabad, Gujarat
382115 |
| 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 Soumallya Hazra |
Dept. of Conservative Dentistry And Endodontics |
Room No. 7 ,College of Dental Sciences & Research Centre, Opp. Pleasure Club, Near Navneet Printing Press, Bopal, Ghuma – Manipur, Ahmedabad – 382115.
Ahmadabad
GUJARAT |
7990185880
soumallyahazra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,College of Dental Science and Research Centre,Ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
HEDP with Ultrasonic and Diode Laser |
1:1 mixture of sodium hypochlorite and 18% HEDP activated using ultrasonic tip for 30 sec and Diode laser 980nm activated with 2.5 watt power for 5sec for 4 cycle |
| Intervention |
Sodium Hypochloride With Ultrasonic And Diode Laser |
3% Naocl is activated with ultrasonic tip for 30 sec cycle
and with 980nm laser using 2.5W for 5 sec of 4 cycle. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
58.00 Year(s) |
| Gender |
Both |
| Details |
Permanent Single rooted tooth
Patient in good health with no systemic disease
Patient diagnosed with asymptomatic irreversible pulpitis
Patient able to understand VAS scale |
|
| ExclusionCriteria |
| Details |
History of any mdicine (Any analgsic )in past 12 hrs.
Medically compromised patients.
Open apex
Pateint having pacemaker placed in their body. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of pain measured by VAS score |
Reduction of pain measured by VAS score in 12hrs, 24 hrs, 48hrs, 72hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Elimination of pain measured by VAS score |
VAS score at 12,24,48 and 72hrs |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/06/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Objectives -: To Evaluate and Compare the effect of Irrigating Agents and Irrigation Activation Technique on postoperative pain in endodontically treated teeth. Materials and methods -:Patients having Asymptomatic Irreversible Pulpitis in single rooted tooth with no periapical involvement will be involved in the study. Cases will be classified into different irrigating agents groups according to different irrigation activation method. Single visit root canal treatment will be done. Postoperative pain will be evaluated after 12,24, 48, and 72 hrs with the help of VAS scale. Need of the study-: It is to determine the impact of laser activation technique and ultrasonic activation technique using novel irrigating agents on postoperative pain. |