| CTRI Number |
CTRI/2025/06/089343 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To compare effect of a medicine on pain reduction before starting of root canal treatment |
|
Scientific Title of Study
|
Effect of premedication with ibuprofen on pain perception in patients during root canal procedure with symptomatic irreversible pulpitis with apical periodontitis - A randomised clinical trial.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amreen Firdose |
| Designation |
Postgraduate |
| Affiliation |
Dayananda Sagar College of Dental sciences |
| Address |
2nd floor, room no 1, Department of Conservative and Endodontics, Dayananda Sagar College of Dental sciences.
S M Hills, Kumarswamy Layout
Bangalore
KARNATAKA
560111
India |
| Phone |
09380863597 |
| Fax |
|
| Email |
amreen.amr7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ashok HK |
| Designation |
Reader, Department of Conservative and Endodontics |
| Affiliation |
Dayananda Sagar Dental college |
| Address |
2nd floor, room no 1, Department of Conservative and Endodontics, Dayananda Sagar College of Dental sciences.
S M Hills, Kumarswamy Layout
KARNATAKA
560111
India |
| Phone |
|
| Fax |
|
| Email |
aaamovies1000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amreen Firdose |
| Designation |
Postgraduate |
| Affiliation |
Dayananda Sagar Dental college |
| Address |
2nd floor, room no 1, Department of Conservative and Endodontics, Dayananda Sagar College of Dental sciences.
S M Hills, Kumarswamy Layout
KARNATAKA
560051
India |
| Phone |
09380863597 |
| Fax |
|
| Email |
amreen.amr7@gmail.com |
|
|
Source of Monetary or Material Support
|
| 2nd floor, room no 1, Department of Conservative and Endodontics, Dayananda Sagar College of Dental sciences,Bangalore, Karnataka - 560 111 |
|
|
Primary Sponsor
|
| Name |
Dr Amreen Fidose |
| Address |
Dayananda Sagar Dental college s m hills kumarswamy layout, Bangalore |
| 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 |
| Dr Amreen Firdose |
Dayananda Sagar College of Dental Sciences |
2nd Floor,Room 1, Department of Consevative and Endodontics, Dayananda Sagar College of Dental Sciences,Kumarswamy Layout, Bangalore, Karnataka
Bangalore
KARNATAKA |
09380863597
amreen.amr7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board- Dayananda Sagar College of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients requiring root canal procedure |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ibuprofen |
Ibuprofen Dose- 400mg
Frequency- 1 time
route of administration- Oral
Duration- 30 minutes before procedure |
| Comparator Agent |
Placebo |
placebo Dose- 400mg
Frequency- 1 time
route of administration- Oral
Duration- 30 minutes before procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients requiring non-surgical endodontic therapy with symptomatic irreversible pulpitis with apical periodontitis |
|
| ExclusionCriteria |
| Details |
Patients who have taken analgesic or anti-inflammatory drugs within 24 hours of initiation of root canal treatment. subjects with known allergy to NSAIDS, pregnant women, immunocompromised patients, occlusal disorders,periodontitis, systemic disorders like asthma , GI disorders, renal and hepatic diseases. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess pain perception with premedication of Ibuprofen in patients during root canal procedure with symptomatic irreversible pulpitis with apical periodontitis.
|
15 minutes , 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess pain perception with premedication of Placebo in patients during root canal procedure with symptomatic irreversible pulpitis with apical periodontitis.
To compare the pain perception with premedication of Ibuprofen and Placebo in patients during root canal procedure with symptomatic irreversible pulpitis with apical periodontitis.
|
15 minutes, 30 minutes |
| To compare gender distribution for pain perception. |
15 minutes , 30 minutes |
|
|
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)
|
20/07/2025 |
| 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="1"
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
|
Endodontic treatment is usually associated with pain. Managing the pain is fundamental for successful endodontic treatment. pain during root canal procedure is common, although the use of local anaesthetic will reduce and lower the threshold of pain. Some patients experience pain after successful nerve block and require supplemental nerve block. Pre operative single oral dose of anti-inflammatory drugs can regulate the release of inflammatory mediators and reduce the amount of side effects compared with repeated doses of local anaesthesia during the procedure. This study aims to evaluate clinically the effectiveness of pre-medication with single oral dose of ibuprofen on pain perception in patients during root canal procedure with symptomatic irreversible pulpitis and apical periodontitis. 60 subjects voluntarily willing to participate in the study matching the inclusion criteria will be selected and will randomly be allocated and administered ibuprofen 400mg and placebo 30 minutes prior to the procedure. Routine endodontic procedure will be carried out after administration of local anaesthesia. Subjects will be asked to mark the highest level of pain perception they experience before administration of pre-medications, 15 and 30 minutes after administration of LA. |