| CTRI Number |
CTRI/2022/11/047540 [Registered on: 23/11/2022] Trial Registered Prospectively |
| Last Modified On: |
18/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Cold Therapy-A method to reduce pain after Root Canal Treatment |
|
Scientific Title of Study
|
Cryotherapy as non-pharmacological alternative for management of postoperative endodontic pain after one-visit root canal treatment using three irrigating regimens at different temperatures. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vartika Pupneja |
| Designation |
MDS Student |
| Affiliation |
Surendera Dental College and Research Institute |
| Address |
Surendera Dental College and Research Institute,Sri Ganganagar
PLOT NO.-26,SECTOR NO.-12,Near Rajasthan Hair Dresser, Hnaumangarh Junction ,Hnaumangarh
Hanumangarh
RAJASTHAN
335001
India |
| Phone |
7014548042 |
| Fax |
|
| Email |
vartikap03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neetu Jindal |
| Designation |
HOD |
| Affiliation |
Surendera Dental College and Research Institute |
| Address |
Surendera Dental College and Research Institute,Sri Ganganagar
L-17, Vridh Aasram Rd, near Amba Hospital, Model Town, Sri Ganganagar,
Ganganagar
RAJASTHAN
335001
India |
| Phone |
9929854146 |
| Fax |
|
| Email |
drneetujindal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vartika Pupneja |
| Designation |
MDS Student |
| Affiliation |
Surendera Dental College and Research Institute |
| Address |
Surendera Dental College and Research Institute,Sri Ganganagar
PLOT NO.-26,SECTOR NO.-12,Near Rajasthan Hair Dresser, Hnaumangarh Junction ,Hnaumangarh
Hanumangarh
RAJASTHAN
335001
India |
| Phone |
7014548042 |
| Fax |
|
| Email |
vartikap03@gmail.com |
|
|
Source of Monetary or Material Support
|
| SURENDERA DENTAL COLLEGE AND RESEARCH INSTITUTE, HIS HIGHNESS GARDENS, SRI GANGANAGAR, RAJASTHAN |
|
|
Primary Sponsor
|
| Name |
Dr Neetu Jindal |
| Address |
Surendera Dental College and Research Institute |
| Type of Sponsor |
Other [Guide] |
|
|
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 |
| Vartika Pupneja |
Surendera Dental College and Research Instritute |
Department of Conservative Dentistry & Endodontics, room no. -5,Surendera Dental College and Research Instritute
Ganganagar
RAJASTHAN |
7014548042
vartikap03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical CommitteeSurendera Dental College and Research Instritute |
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 |
Cryotreated saline |
Final irrigation in a root canal treatment is done by cryotreated saline at 4and 2.5 degree celsius in the experimental groups |
| Comparator Agent |
Saline at room temprature |
The study is designed to evaluate the effectiveness of cryotreated saline with saline used at room temperature |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
The patient requiring endodontic therapy and are
healthy without systemic disease
|
|
| ExclusionCriteria |
| Details |
Patient who are medically compromised
Pregnant patients
Teeth with incomplete apex formation
Teeth with calcified canals
Sinus opening
Periapical abscess
Patients on antibiotic therapy
Patients on analgesics.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cryotherapy being effective in reducing post operative pain after single sitting root canal treatment |
baseline, 24hours,48 hours,72 hours and 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The amount of analgesic intake post operatively after single sitting root canal treatment |
baseline, 24hours,48 hours,72 hours and 7 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
01/12/2022 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
Title- Cryotherapy as a non-pharmacological alternative for the management of postoperative endodontic pain after one-visit root canal treatment using three irrigating regimens at different temperatures. Aim-The aim of this study is to evaluate and compare the effect of intracanal cryotreated saline at different temperatures and at room temperature on postendodontic pain after root canal treatment. Methodology-: A total of 60 patients aged ≥18 years will be integrated in this clinical trial. All patients presented with single canal, teeth indicated for single –visit RCT, and patients with good general health will be included. After obtaining consent and recording preoperative VAS scores of pain on percussion, the access cavity will be prepared under local anesthesia. After completion of cleaning and shaping, the patients will be randomly divided into three groups on the basis of final irrigation : Group A-Saline at room temperature (control group), Group B- Cold saline (at 4°c) and Group C- Cold saline (at 2.5°c).The canals will be dried and obturated in the same appointment. Postoperative visual analogue scale pain levels will be recorded at 24, 48, 72 hours and after 7 days. The data will be analysed using one way ANOVA and Chi square test. |