| CTRI Number |
CTRI/2025/07/091406 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to study the clinical efficacy of 3 different protocols for disinfection of the root canals according to temperature in reducing postoperative pain after a root canal treatment done in a single day |
|
Scientific Title of Study
|
Comparative clinical evaluation of Postoperative Pain using 3% Cryotreated Hypochlorite and 0.9% Cryotreated Normal Saline against Conventional root canal treated groups in patients with Symptomatic Irreversible Pulpitis/ Apical Periodontitis after single visit root canal treatment: 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 Aditi Goel |
| Designation |
PG Student |
| Affiliation |
K.M Shah Dental College and Hospital |
| Address |
Room number 8, Department of Conservative Dentistry and Endodontics, K.M Shah Dental College and Hospital, Piparia, Waghodia Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8511583363 |
| Fax |
|
| Email |
adigoel00@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nimisha Shah |
| Designation |
Head of Department and PG Guide |
| Affiliation |
K.M Shah Dental College and Hospital |
| Address |
Room number 8, Department of Conservative Dentistry and Endodontics, K.M Shah Dental College and Hospital, Piparia, Waghodia Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9998994299 |
| Fax |
|
| Email |
nshah7873@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditi Goel |
| Designation |
PG Student |
| Affiliation |
K.M Shah Dental College and Hospital |
| Address |
Room number 8, Department of Conservative Dentistry and Endodontics, K.M Shah Dental College and Hospital, Piparia, Waghodia Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8511583363 |
| Fax |
|
| Email |
adigoel00@gmail.com |
|
|
Source of Monetary or Material Support
|
| K.M Shah Dental College and Hospital, Piparia, Waghodia, Vadodara, Gujarat, India 391760 |
|
|
Primary Sponsor
|
| Name |
Dr Aditi Goel |
| Address |
Room number 8, Department of Conservative Dentistry and Endodontics, K.M Shah Dental College and Hospital, Piparia, Waghodia, Vadodara, Gujarat, India 391760 |
| 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 Aditi Goel |
K.M Shah Dental College and Hospital |
Room number 8, Department of Conservative Dentistry and Endodontics, K.M Shah Dental College and Hospital, Piparia, Waghodia, Vadodara
Vadodara
GUJARAT |
8511583363
adigoel00@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.9% Cryotreated Normal Saline |
0.9% Normal Saline irrigant at 2°C–4°C along with passive ultrasonic irrigation |
| Intervention |
3% Cryotreated Hypochlorite |
3% Sodium Hypochlorite irrigant at 2°C–4°C along with passive ultasonic irrigation |
| Comparator Agent |
3% Sodium hypochlorite and 0.9% normal saline |
3% Sodium hypochlorite and 0.9% normal saline irrigants at room temperature along with passive ultrasonic irrigation |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy patient who will give informed consent will be included.
2. Single rooted teeth with completely matured root diagnosed with symptomatic irreversible pulpitis / apical periodontitis will be included.
3. Teeth with Peri Apical Index score 2 will be included in the study
|
|
| ExclusionCriteria |
| Details |
1. Teeth with immature roots, those diagnosed with pulp necrosis, cracks, internal/external root resorption or pulp canal obliteration and exhibiting clinical and/or radiographic signs of chronic/severe periodontitis or periapical abscess will be excluded.
2. Patients taking antibiotics, sedatives or analgesics before 24 hrs. of treatment will be excluded.
3. Teeth with previously endodontic treatment will be excluded.
4. Patients with severe periodontitis and poor oral hygiene will be excluded from the study.
5. Pregnant or lactating women will be excluded.
|
|
|
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 |
| Postoperative pain |
6 hours , 24 hours , 48 hours , 72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="69"
Sample Size from India="69"
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)
|
01/08/2025 |
| 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 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 study is single centre, double blinded study comparing the postoperative pain after single sitting root canal treatment using either 3% cryotreated Sodium hypochlorite(2°C–4°C) or 0.9% cryotreated normal saline(2°C–4°C) or 3% Sodium hypochlorite and 0.9% normal saline at room temperature along with passive ultrasonic irrigation in patients with symptomatic irreversible pulpitis / apical periodontitis. Clinical evaluation will be done based on postoperative pain after 6 hours, 24 hours , 48 hours and 72 hours using VRS scale. |