| CTRI Number |
CTRI/2023/07/055176 [Registered on: 13/07/2023] Trial Registered Prospectively |
| Last Modified On: |
09/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Diagnostic
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study evaluating the effect of four commonly prescribed pain killers on dental diagnostic tests |
|
Scientific Title of Study
|
A prospective randomized controlled double blinded clinical trial evaluating the effect of four commonly prescribed analgesics on pulpal sensibility tests |
| 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 Rajat Kapur |
| Designation |
Post Graduate Student |
| Affiliation |
National Dental College and Hospital |
| Address |
Department of conservative dentistry and endodontics, Room number 8, Second floor, National Dental College and Hospital, Bhagat Singh Nagar, Dera Bassi, Punjab
Rupnagar
PUNJAB
140507
India |
| Phone |
9988261689 |
| Fax |
|
| Email |
dr.kapur09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navjot Singh Mann |
| Designation |
Professor and Head |
| Affiliation |
National Dental College and Hospital |
| Address |
Department of conservative dentistry and endodontics, Room number 8, Second floor, National Dental College and Hospital, Bhagat Singh Nagar, Dera Bassi, Punjab
Rupnagar
PUNJAB
140507
India |
| Phone |
9915311355 |
| Fax |
|
| Email |
hodconsendondch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajat Kapur |
| Designation |
Post Graduate Student |
| Affiliation |
National Dental College and Hospital |
| Address |
Department of conservative dentistry and endodontics, Room number 8, Second floor, National Dental College and Hospital, Bhagat Singh Nagar, Dera Bassi, Punjab
Rupnagar
PUNJAB
140507
India |
| Phone |
9988261689 |
| Fax |
|
| Email |
dr.kapur09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of conservative dentistry and endodontics, Room number 8, Second floor, National Dental College and Hospital, Bhagat Singh Nagar, Dera Bassi, Punjab |
|
|
Primary Sponsor
|
| Name |
Dr Rajat kapur |
| Address |
National Dental College and hospital, Bhagat Singh Nagar, Dera Bassi, Punjab 140507 |
| Type of Sponsor |
Other [Dental college] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Navjot Singh Mann |
National Dental College, Bhagat Singh Nagar, Dera Bassi, Punjab 140507 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajat Kapur |
National dental college and hospital |
Department of conservative dentistry and endodontics, Room number 8, Second floor
|
9988261689
dr.kapur09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee NDCH |
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 |
Ketorolac tromethamine, Ibuprofen, Acetaminophen, Diclofenac
|
Ketorolac tromethamine (10mg), Ibuprofen (400mg), Acetaminophen (650mg), Diclofenac (100mg) as per randomization will be given to the patients by the same method at 20, 40 and 60 minutes interval in 1 hour
|
| Comparator Agent |
Placebo |
Tab. Glucose 18 gm as per randomization will be given to the patients by the same method at 20, 40 and 60 minutes interval in 1 hour |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult males & females between 18-65 years of age with moderate to severe pain due to symptomatic irreversible pulpitis (SIP) will be selected for this study. The subjects should not have used any analgesic or anti-depressant in past 6 hrs. |
|
| ExclusionCriteria |
| Details |
1) If the subject has consumed an analgesic or an anti-depressant less than six hours before presentation to the dental office will be excluded.
2) A selected candidate who refuses to sign the informed consent to be a part of this study shall not be included in the study.
3) Any subject who is allergic to any of the drugs being studied will be excluded from the study or if for medical reasons cannot be prescribed NSAIDs will also not be included.
4) If the tooth with SIP does not respond to cold test or If the tooth has periapical disease, it will be excluded from the study.
5) Participants with American Society of Anesthesiology (ASA) physical status > 1 will be excluded.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The drugs under study will surely effect the pain perception of the patient & hence cause modification in the pulp sensibility reflected by the VAS scale for pain. This will help us reach a conclusion which NSAID should be given prior to treatment in cases of symptomatic irreversible pulpits, a highly painful situation so that the patient has a pleasant & pain free experience during the treatment of a painful tooth. |
It involves data at 0 minutes, 20 minutes, 40 minutes & 60 minutes & would be a single sitting procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/08/2023 |
| Date of Study Completion (India) |
13/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
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 - Researchers who provide a methodologically sound proposal.
- 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 [dr.kapur09@gmail.com].
- For how long will this data be available start date provided 01-11-2024 and end date provided 01-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
A correct clinical and radiographic diagnosis is of utmost significance in endodontic treatment. The tooth sensibility tests are a common method to aid in clinical diagnosis. An analgesic consumed before the dental treatment can hide patient’s symptoms leading to false negative response to sensibility tests. The cold test (thermal) and the electronic pulp test (electric) are the two most commonly used sensibility tests which aids in endodontic diagnosis. This study is an attempt to evaluate the effect of commonly used analgesics prior to the first diagnostic visit on the sensibility tests. |