| CTRI Number |
CTRI/2025/03/082511 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
23/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of the effect of five different irrigants on pain after single visit root canal treatment for patients with severe tooth pain |
|
Scientific Title of Study
|
Comparative evaluation of effect of five different intracanal irrigants on post endodontic pain in single visit root canal treatment of teeth with Symptomatic irreversible pulpitis: 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 Sanskruti Vasant Rele |
| Designation |
Post graduate student |
| Affiliation |
Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental college, Dhule |
| Address |
Department of Conservative Dentistry and Endodontics, Room No 4, floor No 2nd,Block B, Annasaheb Chudaman Patil Memorial Dental college, Sakri road, Dhule, tal.Dist.- Dhule,
Dhule
MAHARASHTRA
424001
India |
| Phone |
9422558109 |
| Fax |
|
| Email |
rsanskruti24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Deore |
| Designation |
Reader |
| Affiliation |
Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental college, Dhule |
| Address |
Department of Conservative Dentistry and Endodontics, Room No 4, floor No 2nd,Block B, Annasaheb Chudaman Patil Memorial Dental college, Sakri road, Dhule, tal.Dist.- Dhule,
Dhule
MAHARASHTRA
424001
India |
| Phone |
9730119747 |
| Fax |
|
| Email |
rahuldeore28@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanskruti Vasant Rele |
| Designation |
Post graduate student |
| Affiliation |
Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental college, Dhule |
| Address |
Department of Conservative Dentistry and Endodontics, Room No 4, floor No 2nd,Block B, Annasaheb Chudaman Patil Memorial Dental college, Sakri road, Dhule, tal.Dist.- Dhule,
Dhule
MAHARASHTRA
424001
India |
| Phone |
9422558109 |
| Fax |
|
| Email |
rsanskruti24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawahar medical Foundations, Annasaheb Chudaman Patil Memorial Detal college, Department of Conservative Dentistry and Endodontics, Room No 4, Sakri road, Dhule, tal.Dist.- Dhule, pin-424001, State - Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Sanskruti Vasant Rele |
| Address |
Department of Conservative Dentistry and Endodontics, Room No 4, Annasaheb Chudaman Patil Memorial Dental coolege, Sakri road, Dhule, tal.Dist.- Dhule, Affiliated to MUHS Nashik. |
| 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 Sanskruti Vasant Rele |
Jawahar medical Foundations, Annasaheb Chudaman Patil Memorial Dental college |
Room No 4, Department of Conservative Dentistry and Endodontics, Annasaheb Chudaman Patil Memorial Dental college, Sakri road, Dhule, tal.Dist.- Dhule
Dhule
MAHARASHTRA |
9422558109
rsanskruti24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Reg. under NECRBHR, MoHFW, Govt of India - File No. - EC/NEW/INST/2022/2959 |
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 |
Intracanal irrigant |
1) Cold Saline - 5ml of 2.5 degree celcius cold saline 1mm shorter than working length with 30 gauge side vented needle for 1 minute
2) Dexamethasone - 5ml Dexamethasone solution 1mm shorter than working length with 30 gauge side vented needle for 1 minute
3) Ketorolac - 5ml Ketorolac solution 1mm shorter than working length with 30 gauge side vented needle for 1 minute
4) Calendula - 5ml Calendula solution 1mm shorter than working length with 30 gauge side vented needle for 1 minute |
| Comparator Agent |
saline at room temperature |
5 ml of room temperature for 1 minute with a 30-gauge side vented needle 1mm short of working length |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) Premolars and molar teeth diagnosed with Symptomatic Irreversible Pulpitis
2) positive response of pulp tissue to cold test
3)no previously endodontic treatment
4) mature root canals |
|
| ExclusionCriteria |
| Details |
1) Patient using analgesics 12 hours before treatment
2) pregnant and lactating female patient
3) patient with any uncontrolled systemic disease
4) swelling or fistulous tract
5) acute or chronic periapical abscess
6) mobility greater than grade 1
7) pocket depth greater than 5mm
8) periapical radiolucency |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post endodontic pain in single visit root canal treatment of teeth |
Grading the pain using the Visual Analog Scale at Baseline, 6 hours, 24 hours, 72 hours and after 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No Secondary Outcome |
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
22/03/2025 |
| 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="2"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rsanskruti24@gmail.com].
- For how long will this data be available start date provided 01-04-2025 and end date provided 12-02-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a randomized, double blind, parallel group, multi-arm trial comparing the effect of five different intracanal irrigants - Saline at room temperature 5ml, Cold saline 5ml, Dexamethasone 5ml, Ketorolac 5ml and Calendula solution 5ml on post endodontic pain in single visit root canal treatment of teeth with Symptomatic irreversible pulpitis will be conducted in India. The primary outcome will compare and evaluate post endodontic pain in single visit root canal treatment of teeth at Baseline, 6 hours, 24 hours, 72 hours and after 1 week.
|