| CTRI Number |
CTRI/2026/02/104426 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effect of cold salt solution and laser during root canal treatment |
|
Scientific Title of Study
|
Effect of intracanal cryotherapy and diode
laser activation on postoperative pain in single visit root canal treatment a randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Patlolla Suman Raj |
| Designation |
MDS Student |
| Affiliation |
Uttaranchal Dental and Medical Research Institute |
| Address |
Room No.2 Department of Conservative Dentistry and Endodontics Uttaranchal Dental and Medical Research Institute Mazri G NH 72 Dehradun UK 248140
Dehradun
UTTARANCHAL
248140
India |
| Phone |
7032139431 |
| Fax |
|
| Email |
vamshi.patil96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Paras Gupta |
| Designation |
Professor and Head |
| Affiliation |
Uttaranchal Dental and Medical Research Institute |
| Address |
Room No.2 Department of Conservative Dentistry and Endodontics Uttaranchal Dental and Medical Research Institute Mazri G NH 72 Dehradun UK 248140
Dehradun
UTTARANCHAL
248140
India |
| Phone |
9760753244 |
| Fax |
|
| Email |
drpg81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Patlolla Suman Raj |
| Designation |
MDS Student |
| Affiliation |
Uttaranchal Dental and Medical Research Institute |
| Address |
Room No.2 Department of Conservative Dentistry and Endodontics Uttaranchal Dental and Medical Research Institute Mazri G NH 72 Dehradun UK 248140
Dehradun
UTTARANCHAL
248140
India |
| Phone |
7032139431 |
| Fax |
|
| Email |
vamshi.patil96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttaranchal Dental and Medical Research Institute,mazri grant,haridwar road,Dehradun,Uttarakhand,248140,India |
|
|
Primary Sponsor
|
| Name |
Uttaranchal Dental and Medical Research Institute |
| Address |
Uttaranchal Dental and Medical Research Institute Mazri Grant Haridwar Road NH 72 Dehradun UK 248140 |
| Type of Sponsor |
Research institution |
|
|
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 Patlolla Suman Raj |
Uttaranchal Dental and Medical Research Institute |
Room No.2 Department of Conservative Dentistry and Endodontics Mazri grant,Haridwar road
Dehradun
UTTARANCHAL |
7032139431
vamshi.patil96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-UDMRI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adults 18-60 years with symptomatic irreversible pulpitis in single rooted teeth requiring single visit root canal treatment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dioode Lase Activation |
Diode Laser 810-980 nm 200-300 micron fibre, 1-2 W, spiral withdrawl activation for 5-10 seconds per cycle(2-3cycles) |
| Intervention |
Intracanal cryotherapy |
Final rinse with 5ml saline cooled to 2.5degree celsius |
| Comparator Agent |
Room Temperature Saline |
Final irrigation with 5ml normal
saline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Symptomatic irreversible pulpitis
Single rooted teeth with single canal
Preoperative VAS greater than or equal to 4
Normal apical tissues or symptomatic apical periodontitis
Patient consenting for followup |
|
| ExclusionCriteria |
| Details |
Medically compramised patients
Recent analgesic and antibiotic use
Retreatment cases
Mandibular central and lateral incisors
calcified canals
open apices
periapical lesion greater than or equal to 10mm
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain scores VAS 0 to 10 |
6hr,24hr,48hr,72hr,7days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Analgesic intake,if required. |
6hr,24hr,48hr,72hr,7days |
|
|
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)
|
25/03/2026 |
| 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 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
|
This randomized controlled clinical trial aims to compare the effectiveness of intracanal cryotheapy and diode laser activation in reducing postoperative pain after single visit root canal treatment.Sixty patients with symptomatic irreversible pulpitis in single rooted teeth will be randomly divided into three groups 1.room temperature saline 2.cold saline 2.5 degree celsius and 3.diode laser activation .Standadized single visit endodontic procedures will be performed for all participants.Postoperative pain will be assessed using the Visual Analogue Scale at 6,24,48,72 hours and 7 days.The results will be tabulated and a comparison of the difference in pain reduction among the three study groups will be made using the ANOVA test |