| CTRI Number |
CTRI/2025/03/083031 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to assess postoperative pain using cryotherapy and laser irrigation in single visit root canal treatment |
|
Scientific Title of Study
|
A Randomised Control Trial to assess post operative pain following irrigation using cryotherapy and laser activated irrigation techniques during single visit endodontic treatment in symptomatic irreversible pulpitis |
| 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 Bhumika Vaswani |
| Designation |
PG Student |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
Vaswani nivas Lalimali galli opposite Dr Sahu gandhibagh nagpur
Nagpur
MAHARASHTRA
440018
India |
| Phone |
9834315421 |
| Fax |
|
| Email |
bhumikavaswani2707@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratima Shenoi |
| Designation |
Professor and Head of the Department |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
311 Department of conservative dentistry and endodontics
Ranjeet Deshmukh Dental college and Research centre digdoh hills hingna road nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9822220506 |
| Fax |
|
| Email |
prshenoi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhumika Vaswani |
| Designation |
PG Student |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
311 Department of conservative dentistry and endodontics
Ranjeet Deshmukh Dental college and Research centre digdoh hills hingna road nagpur
311 Department of conservative dentistry and endodontics
Ranjeet Deshmukh Dental college and Research centre digdoh hills hingna road nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9834315421 |
| Fax |
|
| Email |
bhumikavaswani2707@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ranjeet Deshmukh Dental College and Research centre,Digdoh hills,Hingna road Nagpur- 440019 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
NOT SPONSORED |
| Address |
NOT APPLICABLE |
| Type of Sponsor |
Other [NA] |
|
|
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 Bhumika Vaswani |
Ranjeet Deshmukh Dental College and Research Centre |
311 Department Of Conservative and Endodontics Ranjeet Deshmukh Dental college and Research centre Hingna Rd Digdoh Hills Police Nagar Nagpur Maharashtra 440019
Nagpur
MAHARASHTRA |
9834315421
bhumikavaswani2707@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ranjeet Deshmukh Dental College |
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 |
| Comparator Agent |
Conventional irrigation technique (standard irrigation technique) |
A Randomised Control Trial to Assess Post-Operative Pain Following Irrigation Using Conventional Irrigation Technique During Single Visit Endodontic Treatment in Symptomatic Irreversible Pulpitis within 3 months |
| Intervention |
Cryotherapy and Laser Activated Irrigation |
A Randomised Control Trial to Assess Post-Operative Pain Following Irrigation Using Cryotherapy and Laser Activated Irrigation Techniques During Single Visit Endodontic Treatment in Symptomatic Irreversible Pulpitis on post- operative pain in single visit endodontic treatment of teeth with symptomatic irreversible pulpitis within 3 months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy patients under the age group of 18-50 years with preoperative pain
Teeth with single root and single canal.
Periodontal ligament region widening with a periapical index (PAI) score of 1.
|
|
| ExclusionCriteria |
| Details |
Medically compromised
Pregnant patients
Teeth with incomplete apex formation
Teeth with calcified canals
Sinus opening and Periapical abscess
Patients on antibiotic therapy and analgesics.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction inpost operative pain after endodontic treatment |
baseline, 6. 24 and 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify effective method for irrigation during endodontic treatment in reducing postoperative pain |
baseline, 6. 24 and 48 hours |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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 |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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="0"
Days="2" |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bhumikavaswani2707@gmail.com].
- For how long will this data be available start date provided 03-01-2025 and end date provided 03-08-2025?
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
|
The purpose of this in
vivo experimental investigation is to compare and evaluate effect of using intracanal canal Cryotherapy versus Laser activated irrigant on post- operative pain in single visit endodontic treatment of
teeth with symptomatic irreversible pulpitis. |