| CTRI Number |
CTRI/2025/02/081348 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
26/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing Pain After Single Visit Root Canal Treatment Using Cold and Room Temperature Irrigating Solutions- A Clinical Study |
|
Scientific Title of Study
|
Comparative Evaluation Of Post
Endodontic Pain In Single Visit Root
Canal Treatment Using Cryo Treated And
Room Temperature Saline and
Dexamethasone Solution As Final
Irrigants: A Randomized Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sejal Jindal |
| Designation |
PG Student |
| Affiliation |
Bhojia Dental College and Hospital |
| Address |
Bhojia Dental College and Hospital , Baddi, Solan, Himachal Pradesh, Department of Conservative Dentistry and Endodonitcs, Room No. 7
Solan
HIMACHAL PRADESH
173205
India |
| Phone |
8816099108 |
| Fax |
|
| Email |
sejaljindal1269@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Himani Lau |
| Designation |
Professor |
| Affiliation |
Bhojia Dental College and Hospital |
| Address |
Bhojia Dental College and Hospital , Baddi, Solan, Himachal Pradesh, Department of Conservative Dentistry and Endodontics, Room No. - 7
Solan
HIMACHAL PRADESH
173205
India |
| Phone |
7982908801 |
| Fax |
|
| Email |
drhimanilau@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sejal Jindal |
| Designation |
PG Student |
| Affiliation |
Bhojia Dental College and Hospital |
| Address |
Bhojia Dental College and Hospital , Baddi, Solan, Himachal Pradesh, Department of Conservative Dentistry and Endodontics, Room No.- 7
Solan
HIMACHAL PRADESH
173205
India |
| Phone |
8816099108 |
| Fax |
|
| Email |
sejaljindal1269@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhojia Dental College and Hospital, Baddi, Solan, Himachal Pradesh, India 173205 |
|
|
Primary Sponsor
|
| Name |
Sejal Jindal |
| Address |
Bhojia Dental College and Hospital , Baddi, Solan, Himachal Pradesh, India, 173205 |
| 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 |
| Dr Sejal Jindal |
Bhojia Dental College and Hospital |
Bhojia Dental College and Hospital, Baddi, Solan, Himachal Pradesh, Department of Conservative Dentistry and Endodontics, 173205
Solan
HIMACHAL PRADESH |
8816099018
sejaljindal1269@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Bhojia Dental College & Hospital Bhud Baddi H.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K04||Diseases of pulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
single dose of 2ml of 0.9% cold saline as intracanal irrigant. |
Post endodontic pain assessment after using 2ml of 0.9% cold saline as final irrigant through intracanal irrigation in single visit root canal treatment. Pain will be assessed after 6, 12, 24 and 48 hours of the treatment. |
| Comparator Agent |
single dose of 2ml of 0.9% saline as intracanal irrigant. |
Post endodontic pain assessment after using 2ml of 0.9% saline at room temperature as final irrigant through intracanal irrigation in single visit root canal treatment. Pain will be assessed after 6,12, 24 and 48 hours of the treatment. |
| Intervention |
single dose of 2ml of 4mg/ml cold Dexamethasone solution as intracanal irrigant. |
Post endodontic pain assessment after using single dose of 2ml of 4mg/ml cold dexamethasone solution as final irrigant through intracanal irrigation in single visit root canal treatment. Pain will be assessed after 6, 12, 24 and 48 hours of the treatment. |
| Intervention |
single dose of 2ml of 4mg/ml Dexamethasone solution at room temperature as intracanal irrigant |
Post endodontic pain assessment after using single dose of 2ml of 4mg/ml dexamethasone solution at room temperature as final irrigant through intracanal irrigation in single visit root canal treatment. Pain will be assessed after 6, 12, 24 and 48 hours of the treatment. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Single rooted single canal teeth.
2 Patients with symptomatic irreversible pulpitis.
3 Patients with pain level 4 or higher on NRS.
4 Teeth with mature root apex
5 Age group 18- 60 years |
|
| ExclusionCriteria |
| Details |
1 Primary endodontic failures/ re-treatment.
2 Teeth with evidence of internal or external root resorption, root fracture,
calcification, open apices and periapical lesion.
3 Teeth not suitable to undergo single visit root canal treatment.
4 Medically compromised patients and pregnant women.
5 Patients with history of medicine intake including NSAIDs, antibiotics,
corticosteroids, opioids, sedatives, anti-anxiety or anti-depressants in past 6
hours.
6 Patients who refuse to participate in the study. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the post endodontic pain of patients undergoing single visit endodontics after using saline at room temperature, cold saline (cryo treated),
dexamethasone at room temperature and cold dexamethasone
(cryo treated) as final irrigants in single visit root canal treatment. |
6 hours,12 hours,24 hours,48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Analgesic intake, evaluated by the number of analgesic tablets taken in post-operative pain. Having an unscheduled appointment for emergency
treatment or any complications such as post-operative swelling. |
6 hours,12 hours,24 hours,48 hours |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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 4 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="3"
Months="0"
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
|
To compare the post endodontic pain in single visit root canal treatment using
different final intracanal irrigants at different temperatures in patients with single
rooted single canal teeth at 6, 12, 24,
and 48 hours. The different final irrigants selected for the present study are saline at room
temperature, cold saline (cryo treated), dexamethasone at room temperature and cold
dexamethasone (cryo treated). |