| CTRI Number |
CTRI/2022/10/046702 [Registered on: 21/10/2022] Trial Registered Prospectively |
| Last Modified On: |
19/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The effect of cold saline as compared with normal saline in patients with pain after single visit root canal treatment. |
|
Scientific Title of Study
|
The Effect of Intracanal Cryotherapy on Post-operative Pain After Single-Visit Root Canal Treatment- An In-Vivo Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pranita Gandhi |
| Designation |
PG Student |
| Affiliation |
ACPM DENTAL COLLEGE |
| Address |
ACPM Dental College, Department of Conservative Dentistry and Endodontics, Department no 4, Cubicle no. 4, Morane, Dhule
Dhule
MAHARASHTRA
424001
India |
| Phone |
8830137263 |
| Fax |
|
| Email |
drpranitagandhi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Deore |
| Designation |
Guide |
| Affiliation |
ACPM DENTAL COLLEGE |
| Address |
ACPM Dental College, Department of Conservative Dentistry and Endodontics, Department no 4, Morane, Dhule
Dhule
MAHARASHTRA
424002
India |
| Phone |
9730119747 |
| Fax |
|
| Email |
rahuldeore28@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranita Gandhi |
| Designation |
PG Student |
| Affiliation |
ACPM DENTAL COLLEGE |
| Address |
ACPM Dental College, Department of Conservative Dentistry and Endodontics, Department no 4, Cubicle no. 4, Morane, Dhule
Dhule
MAHARASHTRA
424001
India |
| Phone |
8830137263 |
| Fax |
|
| Email |
drpranitagandhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| ACPM Dental College, Dhule |
|
|
Primary Sponsor
|
| Name |
Dr Pranita Gandhi |
| Address |
NH-6 Dhule Nagpur Kolkata Highway, Morane, Dhule 424002 |
| Type of Sponsor |
Other [Private Dental College] |
|
|
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 Pranita Gandhi |
ACPM Dental College |
ACPM Dental College, Department of Conservative Dentistry and Endodontics, Second floor, Department no 4, Cubicle number 14
NH-6, Morane, Dhule, 424002
Dhule
MAHARASHTRA |
8830137263
drpranitagandhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ACPM 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 |
| Intervention |
Cryotherapy- Cold Saline |
Cold saline is used as a final irrigant of the root canal therapy. The temperature of the saline is 2.5 degree celsius.5 ml of cold saline is used in each canal and irrigated for over a minute. |
| Comparator Agent |
Physiologic room temperature saline |
In other group, saline at physiologic room temperature was used as the final irrigant in the root canal treatment. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient between 15 to 55 years of age.
2. Mandibular first molas.
3. Symptomatic irreversible pulpitis
4. Teeth indicated for single-visit RCT
5. Patients with good general health |
|
| ExclusionCriteria |
| Details |
1. Medically compromised patient
2. Retreatment cases
3. Internal resorption
4. Open apex
5. Sealer puffs
6. Periapical pathosis
7. Patient who has taken anti-inflammatory or analgesic drugs before treatment. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of Post-operative pain using cold saline and normal physiologic room temperature saline as the final irrigant after single visit root canal treatment using Visual Analog Scale. |
6 hours, 24 hours and 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of Post-operative pain using cold saline and normal physiologic room temperature saline as the final irrigant after single visit root canal treatment using Visual Analog Scale. |
48 hours |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/10/2022 |
| 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="3" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
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-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- 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 [drpranitagandhi@gmail.com].
- For how long will this data be available start date provided 21-11-2022 and end date provided 20-11-2023?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Background- Pain management during and after root
canal treatment is one of the most important aspects of endodontic practice.
One of the primary reasons for initiating endodontic treatment is to rid the
patient of the excruciating pain. In order to control this pain and the
potential pain precipitated as a result of endodontic treatment, various
strategies have been devised and one of these include “cryotherapyâ€. It is
based on the principle of extracting heat from the applied area rather than
implementing cold. The use of cryotherapy during endodontic treatment is
gradually becoming pervasive. This study is planned and carried out so as to
test the effectiveness of cryotherapy. Aim- The purpose of this study is to compare and
evaluate the effect on postoperative pain of patients with symptomatic
irreversible pulpitis using cold saline at 2.5ËšC and physiological room
temperature saline as the final irrigant after single-visit root canal
treatment.
Method and Materials- 30 patients to undergo
endodontic treatment in mandibular first molars are selected, on the basis of
predetermined criteria and divided into two groups. Biomechanical preparation is
done and final irrigation is carried out with either 2.5â°C cold saline or
saline at room temperature. Patients will be asked to rate the intensity of
their postoperative pain using visual analogue scale at 6h, 24h and 1 week.
|