| CTRI Number |
CTRI/2020/12/029536 [Registered on: 03/12/2020] Trial Registered Prospectively |
| Last Modified On: |
25/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of cryotherapy on post-operative pain in irreversible pulpitis and/ or apical periodontitis |
|
Scientific Title of Study
|
The role of cryotherapy in reduction of post-operative pain in patients with irreversible pulpitis and/or apical periodontitis:- A Randomized controlled clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hemal Patel |
| Designation |
Post graduate student |
| Affiliation |
Manubhai patel dental college and hospital and ORI |
| Address |
First floor Department of conservative dentistry endodontics and esthetics
Manubhai patel dental college and hospital and ORI Vishwajyoti aashram near vishwamitri bridge munjmahuda
First floor Department of conservative dentistry endodontics and esthetics
Manubhai patel dental college and hospital and ORI Vishwajyoti aashram near vishwamitri bridge munjmahuda
Vadodara
GUJARAT
390011
India |
| Phone |
8155913762 |
| Fax |
|
| Email |
hemharsh18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonali Kapoor |
| Designation |
Dean professor and PG guide |
| Affiliation |
Manubhai patel dental college and hospital and ORI |
| Address |
First floor Department of conservative dentistry endodontics and esthetics
Manubhai patel dental college and hospital and ORI Vishwajyoti aashram near vishwamitri bridge munjmahuda
First floor Department of conservative dentistry endodontics and esthetics
Manubhai patel dental college and hospital and ORI Vishwajyoti aashram near vishwamitri bridge munjmahuda
Vadodara
GUJARAT
390011
India |
| Phone |
9825323057 |
| Fax |
|
| Email |
drsonalikapoor@mpdentalcollege.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Kapoor |
| Designation |
Dean professor and PG guide |
| Affiliation |
Manubhai patel dental college and hospital and ORI |
| Address |
First floor Department of conservative dentistry endodontics and esthetics
Manubhai patel dental college and hospital and ORI Vishwajyoti aashram near vishwamitri bridge munjmahuda
First floor Department of conservative dentistry endodontics and esthetics
Manubhai patel dental college and hospital and ORI Vishwajyoti aashram near vishwamitri bridge munjmahuda
Vadodara
GUJARAT
390011
India |
| Phone |
9825323057 |
| Fax |
|
| Email |
drsonalikapoor@mpdentalcollege.edu.in |
|
|
Source of Monetary or Material Support
|
| Hemal Patel |
| Manubhai patel dental college and hospital and ORI |
|
|
Primary Sponsor
|
| Name |
Hemal Patel |
| Address |
Department of Conservative and endodontics Manubhai patel dental college and hospital and ORI munjmahuda vadodara gujarat390011 |
| 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 |
| Hemal patel |
Manubhai patel dental college and hospital and ORI |
Department of conservative and endodontics 1st floor PG clinic Manubhai patel dental college and hospital munjamahuda vadodara
Vadodara
GUJARAT |
08155913762
hemharsh18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (IEC) FOR RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individual without systemic disease |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Root canal treatment |
Final irrigation after biomechanical preparation at cold temperature(2-5 degree celsius) with normal saline |
| Intervention |
Root canal treatment |
Final irrigation after biomechanical preparation at room temperature with normal saline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Healthy individuals without systemic disease
Age group between 18-65 years
Patient suffering from irreversible pulpitis and/or apical periodontitis
Single rooted tooth
Tooth with mature apex |
|
| ExclusionCriteria |
| Details |
Individuals with systemic disease
Individuals with swelling
Severly damaged tooth
Tooth previously undergone root canal treatment
Individual who have taken analgesics during past 24 hours
Individual with absence of opposing teeth
Tooth with immature apex
Presence of any defect in root caries restoration root resorption fractures craze lines extreme root curvatures |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine post-operative pain reduction in compatison between final irrigation with normal saline at room temperature and with normal saline at cold temperature(2-5 degree celsius) |
24 and 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine post-operative pain reduction in simultaneous final irrigation with normal saline at room temperature
To determine post-operative pain reduction in simultaneous final irrigation with normal saline at cold temperature(2-5 degree Celsius) |
24 and 48 hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/01/2021 |
| Date of Study Completion (India) |
18/01/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
18/01/2022 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Publication will arise from the results from the data and the results tabulated from this study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Evaluation of post-operative pain in healthy individuals without systemic disease with irreversible pulpitis and/or apical periodontitis in single rooted tooth after final irrigation with normal saline at room temperature and normal saline at cold temperature (2-5 degree celsius) after 24 and 48 hours. |