| CTRI Number |
CTRI/2026/02/104351 [Registered on: 19/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Post-Treatment Pain After Root Canals Done With Ultrasonic activation of Irrigants |
|
Scientific Title of Study
|
A Comparative evaluation of post operative pain with ultrasonically activated Irrigants- Triton vs 3 percent NAOCL in teeth with symptomatic irreversible pulpitis-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 Chandni shah |
| Designation |
PG Student |
| Affiliation |
K M Shah Dental College and Hospital |
| Address |
8,Depatment of Conservative Dentistry and Endodontics, K.M Shah Dental College and Hospital,Sumandeep Vidyapeeth, Waghodia road, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9427439376 |
| Fax |
|
| Email |
drchandni138@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishnu Pratap Singh Rathore |
| Designation |
Professor and PG Guide |
| Affiliation |
K M Shah Dental College and Hospital |
| Address |
8,Depatment of Conservative Dentistry and Endodontics, K.M Shah Dental College and Hospital,Sumandeep Vidyapeeth, Waghodia road, Vadodara
GUJARAT
391760
India |
| Phone |
7575071175 |
| Fax |
|
| Email |
dr.vishnurathore84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandni shah |
| Designation |
PG Student |
| Affiliation |
K M Shah Dental College and Hospital |
| Address |
8,Depatment of Conservative Dentistry and Endodontics, K.M Shah Dental College and Hospital,Sumandeep Vidyapeeth, Waghodia road, Vadodara
GUJARAT
391760
India |
| Phone |
9427439376 |
| Fax |
|
| Email |
drchandni138@gmail.com |
|
|
Source of Monetary or Material Support
|
| 8, Department of Conservative Dentistry and Endodontics, K.M Shah Dental College and Hospital,Sumandeep Vidyapeeth,Waghodiya,Vadodara
vadodara
gujarat
391760
India |
|
|
Primary Sponsor
|
| Name |
Dr Chandni Shah |
| Address |
8, Department of Conservative Dentistry and Endodontics, K.M Shah Dental College and Hospital,Sumandeep Vidyapeeth,Waghodiya,Vadodara -391760
gujarat
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 Chandni Shah |
K.M Shah Dental College and Hospital |
8, Department of Conservative Dentistry and Endodontics, K.M Shah Dental College and Hospital,Sumandeep Vidyapeeth,Waghodiya,Vadodara
Vadodara
GUJARAT |
9427439376
drchandni138@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SUMANDEEP VIDYAPEETH INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
3 % SODIUM HYPOCHLORITE SOLUTION |
Tissue dissolvent and commonly used irrigating agent which here be used 10 ml and with ultrasonic activation it will be activated for 20 s three times |
| Intervention |
TRITON |
The Triton comprises two solutions: Part A containing citric acid, surfactants, and pH modifiers, and Part B containing 8% NaOCl and a pH modifier. When mixed in a 1:1 ratio, the final solution delivers 4% NaOCl,which will be used 10 ml for irrigation and for the ultrasonic activation it will be activated for 20 s three times |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy patients (Category: American Society of Anaesthesiologists class 1) (ASA House of Delegates 2014) aged between 18 to 60 years of age will be included.
2. Patients with preoperative pain scores ranging from moderate to severe (4 to 10) on a visual analog scale (VAS scale).
3. Patients responding positive to pulpal sensitivity by Electronic pulp Test or Thermal stimuli will be included.
4.Maxillary or Mandibular teeth diagnosed with Symptomatic irreversible pulpitis with or without periapical pathology or radiographic rarefaction. (PAI score less than 3)
5.Only those patients ready to sign the consent form will be included in the study.
|
|
| ExclusionCriteria |
| Details |
1.Teeth with open apex, root resorption and calcified pulp chamber and canals will be excluded from the study.
2.Teeth with curvature more than 20 degree will be excluded from the study
3.Patients taking analgesics 12 hours before the intervention.
4.Teeth which had received previous endodontic treatment will be excluded from the study.
5.Cases showing periodontal pockets deeper than 4mm will be excluded from the study.
6.Teeth with pre-op swelling, draining sinus and Flare ups during root canal treatment will be excluded from the study.
7.Any other iatrogenically affected root canal treatments will be excluded from the study.
8.Medically compromised patients will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the result of the study helps us to evaluate the post operative pain in teeth with symptomatic irreversible pulpitis at different time intervals by activating the irrigating solutions which is 3% Sodium Hypochlorite and Triton |
the result of the study helps us to evaluate the post operative pain in teeth with symptomatic irreversible pulpitis at different time intervals which is at 6 hrs,12 hrs,24 hrs and 48 hrs by activating the irrigating solutions which is 3% Sodium Hypochlorite and Triton |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the efficiency of ultrasonically activated triton & 3% NAOCL |
6,12,24 & 48 hrs |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
03/03/2026 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 helps us to evaluate and compare the post-operative pain with Ultrasonically acticated 3% NAOCL and Triton as
root canal irrigants in teeth with
pulpal diagnosis of symptomatic irreversible pulpitis at 6 hrs,12 hrs,24 hrs and 48 hrs. |