| CTRI Number |
CTRI/2024/12/077533 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
post operative pain using different temperature variants of sodium hypo chloride |
|
Scientific Title of Study
|
Evaluation of postoperative pain using warm, cold and room temperature sodium hypochlorite as an irrigant in tooth with symptomatic irreversible pulpitis: An invivo 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 Kirtika Muktawat |
| Designation |
MDS (Postgraduate student) |
| Affiliation |
I.T.S. DENTAL COLLEGE, GREATER NOIDA |
| Address |
Room no.7
Department of Conservative
dentistry and Endodontics
I.T.S. DENTAL COLLEGE, Greater
Noida,
47, Knowledge park 3, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
8439474872 |
| Fax |
|
| Email |
kirtika1209@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ROHIT KOCHHAR |
| Designation |
HOD and Professor |
| Affiliation |
I.T.S. DENTAL COLLEGE, GREATER NOIDA |
| Address |
Room no.7, Department of Conservative
dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Greater
Noida, 47, Knowledge park 3, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9810034451 |
| Fax |
|
| Email |
hod.cons.gn@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr ROHIT KOCHHAR |
| Designation |
HOD and Professor |
| Affiliation |
I.T.S. DENTAL COLLEGE, GREATER NOIDA |
| Address |
Room no.7, Department of Conservative
dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Greater
Noida, 47, Knowledge park 3, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9810034451 |
| Fax |
|
| Email |
hod.cons.gn@its.edu.in |
|
|
Source of Monetary or Material Support
|
| Room no.7, Department of Conservative dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Greater Noida, 47, Knowledge parkn3, Greater Noida - 201308, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
ITS Dental College Hospital and Research Centre |
| Address |
Room no.7, Department of Conservative dentistry and Endodontics,
I.T.S. DENTAL COLLEGE, Greater Noida, 47, Knowledge parkn3,
Greater Noida - 201308, Uttar Pradesh, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kirtika Muktawat |
I.T.S DENTAL COLLEGE, GREATER NOIDA |
Room no.7, Department
of Conservative
dentistry and
Endodontics, I.T.S.
DENTAL COLLEGE,
Greater Noida, 47,
Knowledge parkn3,
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
8439474872
kirtika1209@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patient with sympotamic irreversible pulpitis
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
sodium hypochlorite at different temperature |
use of sodium hypochlorite at different temperature in root canal treatment
Group 1: Sodium hypocholride at 65â°C
Group 2: Sodium hypocholride at 25â°C
Group 3: Sodium hypocholride at 2-4â°C
|
| Comparator Agent |
sodium hypochlorite at room temperature |
sodium hypochlorite at room temperature is most commonly used irrigant in endodontics. so this study compares the post operative pain at room temperature versus cold and warm sodium hypochlorite |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Single rooted tooth
Patient with symptomatic irreversible pulpitis
|
|
| ExclusionCriteria |
| Details |
Re RCT cases
Patient on Immunosuppresive drugs/systemic diseases
Inability to reach full working length
Tooth with draining sinus
Tooth with periapical radiolucency, calcified canals, internal root resorption
pregnant or lactating patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the effect of temperature on post operative pain using different temperature variants of sodium hypochlorite as final irrigant.
|
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluate the best possible temperature for using sodium hypochlorite at minimum post operative pain in root canal treatment |
at the end of the study duration which is 3
months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/12/2024 |
| 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 Applicable |
| 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 - NO
|
|
Brief Summary
|
Sodium hypochlorite (NaOCl) is
one of the most effective intracanal irrigants and has antibacterial
properties; it dissolves vital and nonvital pulp tissues. The study will
be done to compare the severity of pain after the endodontic treatment in single
rooted teeth with irreversible pulpitis following the use of NaOCl irrigant at
different temperatures. The
forthcoming clinical study will be carried out within the Department of
Conservative Dentistry and Endodontics at I.T.S. Dental College, Hospital, and
Research Centre in Greater Noida,Uttar Pradesh A total number of 60 patients will be selected
from the O.P.D of Department of Conservative Dentistry and Endodontics
according to inclusion and exclusion criteria. Inclusion Criteria: Single rooted tooth, Patient with symptomatic
irreversible pulpitis, Age 18-60 years. Exclusion Criteria: Re RCT cases,
Patient on Immunosuppressive
drugs/systemic diseases, Inability to reach full working length, Tooth with
draining sinus, Tooth with periapical radiolucency, calcified canals, internal
root resorption, pregnant or lactating patients. The selected patients
will be further divided into 3 groups: Group 1: Sodium hypocholride at 65â°C, Group 2: Sodium hypocholride at 25â°C, Group 3:
Sodium hypocholride at 2-4â°C. Irrigation between each filing will be done using normal saline with
side vented needles. After biomechanical preparation, final irrigation will be
done with different temperature variants of sodium hypochloride with side
vented needles. All canals will be dried using appropriate size paper points
and obturated in same appointment using cold lateral compaction technique. Access
cavity restoration will be done with composite. After 6, 24, and 48 h post
operative pain will be assessed using VAS score. The number of analgesic pills that
had been taken by the patient at each follow-up period, and will be recorded on
patient’s chart. |