| CTRI Number |
CTRI/2024/10/075476 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TO COMPARE THE EFFECTIVENESS OF KETOROLAC TROMETHAMINE AND DEXAMETHASONE WHEN USED AS FINAL IRRIGANT AFTER PULPECTOMY IN REDUCTION OF POST TREATMENT ENDODONTIC PAIN IN CHILDREN AGED 7 - 9 YEARS A RANDOMISED CONTROLLED CLINICAL TRIAL |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF THE EFFECTIVENESS OF KETOROLAC TROMETHAMINE AND DEXAMETHASONE IRRIGATION ON POST TREATMENT ENDODONTIC PAIN IN CHILDREN AGED 7 to 9 YEARS OF AGE: A RANDOMIZED CONTROL 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 |
Arjun Desani |
| Designation |
Post-graduate student |
| Affiliation |
Pacific Dental College and Hospital |
| Address |
Dept. of Pediatric and Preventive Dentistry, Room No. 09, Pacific Dental College and Hospital
Debari Near Airport Road
Dept. of Pediatric and Preventive Dentistry, Room No. 09, Pacific Dental College and Hospital
Debari Near Airport Road
Udaipur
RAJASTHAN
313024
India |
| Phone |
8866111978 |
| Fax |
|
| Email |
killadrama3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dinesh Rao |
| Designation |
HOD Pg guide |
| Affiliation |
Pacific Dental College and Hospital |
| Address |
Dept. of Pediatric and Preventive Dentistry, Room No. 09, Pacific Dental College and Hospital
Debari Near Airport Road
Dept. of Pediatric and Preventive Dentistry, Room No. 09, Pacific Dental College and Hospital
Debari Near Airport Road
Udaipur
RAJASTHAN
313024
India |
| Phone |
9414158235 |
| Fax |
|
| Email |
pedodinesh2003@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Arjun Desani |
| Designation |
Post - graduate student |
| Affiliation |
Pacific Dental College and Hospital |
| Address |
Dept. of Pediatric and Preventive Dentistry, Room No. 09, Pacific Dental College and Hospital
Debari Near Airport Road
Dept. of Pediatric and Preventive Dentistry, Room No. 09, Pacific Dental College and Hospital
Debari Near Airport Road
Udaipur
RAJASTHAN
313024
India |
| Phone |
8866111978 |
| Fax |
|
| Email |
killadrama3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. of Pediatric and Preventive Dentistry, Room No. 09, Pacific Dental College and Hospital Debari, Near Airport Road, Udaipur Rajasthan, 313024 |
|
|
Primary Sponsor
|
| Name |
Dr Arjun Desani |
| Address |
Dept. of Pediatric and Preventive Dentistry, Room No. 09, Pacific Dental College and Hospital
Debari Near Airport Road, Udaipur, Rajasthan, 313024 |
| Type of Sponsor |
Other [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 |
| Arjun Desani |
Pacific Dental College and Hospital |
Department of Pediatric and Preventive Dentistry first floor room number nine Pacific Dental College and Hospital,
Airport road,
Debari,
Udaipur (Rajasthan) - 313024
Udaipur
RAJASTHAN |
8866111978
killadrama3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pacific Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, (2) ICD-10 Condition: B950||Streptococcus, group A, as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KETOROLAC TROMETHAMINE AND DEXAMETHASONE
|
After cleaning and shaping, the canals will be dried in groups one and two. Ketorolac tromethamine (0.5 mg/ml) and dexamethasone (0.5 mg/ml) will be irrigated intracanally. The method of placement will be as follows: a 27-gauge needle will be placed into the canal until resistance is felt, then 5 ml of the irrigation solution will be expressed slowly into each
canal. |
| Comparator Agent |
Saline |
a 27-gauge needle will be placed into the canal until resistance is felt, then 5 ml of the irrigation solution will be expressed slowly into each canal, Patients in this group will receive oral placebo as normal saline irrigation |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Medically fit children aged between 7 to 9 years
•
Children who are mentally capable of communication and those who can follow the instructions and be able to interpret the pain perception appropriately
•
Patients undergoing root canal treatment of primary mandibular teeth
•
All the patients who will report moderate to severe pain of continuous or nocturnal, radiating, or throbbing pain
•
Teeth responding to the cold sensibility test with exaggerated pain |
|
| ExclusionCriteria |
| Details |
1. Patients with acute signs and symptoms requiring emergency treatment, with previous painful dental experience, and who are medically compromised
2. Grossly decayed teeth
3. History of any post-traumatic stress disorders or specific phobias related to dental settings
4. History of systemic mental or physical disorders
5. Restored, root fractures, periapical pathology, variations in roots
6. Cardiac patients
7. Patients taking medication 3 days prior
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| FINAL IRRIGATION WITH KETOROLAC TROMETHAMINE AND DEXAMETHASONE RESULTED IN LESS POST TREATMENT ENDODONTIC PAIN AND REDUCED THE NEED FOR TAKING ANALGESIC AFTER TREATMENT |
AFTER FINAL IRRIGATION DONE USING KETOROLAC TROMETHAMINE AND DEXAMETHASONE, POST TREATMENT ENDODONTIC PAIN WAS REDUCED SIGNIFICANTLY, AND THE NEED FOR TAKING ANALGESICS FOR POST TREATMENT ENDODONTIC PAIN WAS ALSO REDUCED |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| FINAL IRRIGATION WITH KETOROLAC TROMETHAMINE AND DEXAMETHASONE RESULTED IN NO REDUCTION OF POST TREATMENT ENDODONTIC PAIN AND THE PATIENT NEEDED ANALGESICS TO RELIEVE PAIN |
EVEN AFTER USING KETOROLAC TROMETHAMINE AND DEXAMETHASONE AS THE FINAL IRRIGANTS, THERE WAS NO REDUCTION IN POST TREATMENT ENDODONTIC PAIN AND PATIENT NEEDED TO TAKE ANALGESICS TO RELIEVE PAIN |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 3 |
|
Date of First Enrollment (India)
|
25/10/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The use of
ketorolac tromethamine and dexamethasone as root canal final irrigants can optimize
pain management strategies in pediatric endodontic treatments, leading to
improved clinical outcomes and patient experiences. It can also help in eliminating the need for taking post - treatment endodontic pain. |