| CTRI Number |
CTRI/2026/01/100546 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare pain following single-visit root canal treatment with different cold treated root canal irrigants |
|
Scientific Title of Study
|
Comparative evaluation of post-operative pain following single-visit root canal treatment with cryomodified root canal irrigants: 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 Ketaki Gundawar |
| Designation |
Post graduate student |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital, Sankalchand Patel University |
| Address |
S P Sahakar Vidyadham Ambaji Gandhinagar Link Road Near
Kamana Char Rasta Visnagar
room no. 5 department of conservative dentistry and
endodontics
Mahesana
GUJARAT
382440
India |
| Phone |
9638768630 |
| Fax |
|
| Email |
kaktisap@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kailash Attur |
| Designation |
Professor and HOD |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital |
| Address |
Room No 5 Department of conservative dentistry and endodontics
Narsinhbhai patel dental college and hospital Sankalchand patel
university Visnagar
Mahesana
GUJARAT
384315
India |
| Phone |
9727752499 |
| Fax |
|
| Email |
atturkailash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kailash Attur |
| Designation |
Professor and HOD |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital |
| Address |
Room No 5 Department of conservative dentistry and endodontics
Narsinhbhai patel dental college and hospital Sankalchand patel
university Visnagar
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 Dental school in Visnagar Gujarat India 384315
|
|
|
Primary Sponsor
|
| Name |
Dr Ketaki Gundawar |
| Address |
25, elysian villas, besides kailash shikhar, near pratham upvans, sun pharma road, atladara, vadodara, gujarat |
| 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 Ketaki Gundawar |
Narsinhbhai Patel Dental College and Hospital |
Room no 5
Department of
Conservative
Dentistry Narsinhbhai
Patel Dental College
and Hospital Nootan
dental college dental
college Visnagar
Mahesana
GUJARAT |
9638768630
kaktisap@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Narsinhbhai Patel Dental College Visnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patient requiring root canal treatment |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
at different temperatures |
To evaluate post-operative pain using 2 different root canal irrigants at 2 different temperatures using VAS scale at 6, 12, 24, 48 hours |
| Intervention |
Evaluation of post-operative pain |
Evaluation of post-operative pain by using different root canal irrigants at 6, 12, 24, 48 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
The patient requiring endodontic therapy.
Single rooted permanent teeth that will be diagnosed with symptomatic irreversible pulpitis.
Healthy patients without systemic disease.
Patients with pain score ranging from moderate to severe (3–10) on a Visual Analog Scale (VAS)
(0–10)
Ability to fill the root canals in a single visit. |
|
| ExclusionCriteria |
| Details |
Patient who are medically compromised.
Pregnant patients.
Patients on antibiotic therapy.
Patients on analgesics.
Teeth with incomplete apex formation or root resorption.
Teeth with anatomical or morphological anomalies.
Teeth with calcified canals.
Teeth with sinus opening.
Teeth with periapical pathology. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of post operative pain will be less using Twin Kleen(etidronic acid) |
Pain will be evaluated at 6, 12, 24, 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of post operative pain will be less using cryotreated(0 degree Celcius)Twin Kleen(etidronic acid) |
Pain will be evaluated at 6, 12, 24, 48 hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
31/03/2026 |
| 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="0"
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
|
Eighty mature permanent single-rooted teeth requiring endodontic treatment will be included in the study and will be divided into four groups Group A Room temperature sodium hypochlorite Group B Cryotreated sodium hypochlorite Group C Room temperature Twin Kleen Group D Cryotreated Twin Kleen Each group will receive 10 ml of the respective irrigant for 5 minutes per canal |