| CTRI Number |
CTRI/2025/05/087007 [Registered on: 15/05/2025] Trial Registered Prospectively |
| Last Modified On: |
20/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Evaluate The Dose Dependent Effects of Ibuprofen and Dexamethasone as Oral Premedication on the Success rate of Inferior Alveolar Nerve Block (IANB) in patients with Symptomatic Irreversible Pulpitis. |
|
Scientific Title of Study
|
Efficacy Of Ibuprofen And Dexamethasone For Enhanced Success Of Inferior Alveolar Nerve Block In Irreversible Pulpitis: A Prospective, 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 |
Chandani Agrawal |
| Designation |
Junior Resident |
| Affiliation |
Dr. Ziauddin Ahmad Dental College and Hospital |
| Address |
OPD-7, PG Clinic, Department of Conservative Dentistry And Endodontics, Dr. Ziauddin Ahmad Dental college and Hospital,AMU Campus, Medical Road, Aligarh
OPD-7, PG Clinic, Department of Conservative Dentistry And Endodontics, Dr. Ziauddin Ahmad Dental college and Hospital,AMU Campus, Medical Road, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8218308973 |
| Fax |
|
| Email |
chandani.agr2297@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAshok Kumar |
| Designation |
Professor |
| Affiliation |
Dr. Ziauddin Ahmad Dental College and Hospital |
| Address |
OPD 7,Department of Conservative Dentistry And Endodontics, Dr. Ziauddin Ahmad Dental college and Hospital,AMU Campus, Medical Road, Aligarh
OPD-7, Department of Conservative Dentistry And Endodontics, Dr. Ziauddin Ahmad Dental college and Hospital,AMU Campus, Medical Road, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9412732327 |
| Fax |
|
| Email |
ashokoperative@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sajid ali |
| Designation |
Assistant Professor |
| Affiliation |
Dr. Ziauddin Ahmad Dental College and Hospital |
| Address |
OPD-7, Department of Conservative Dentistry And Endodontics, Dr. Ziauddin Ahmad Dental college and Hospital,AMU Campus, Medical Road, Aligarh
OPD-7, Department of Conservative Dentistry And Endodontics, Dr. Ziauddin Ahmad Dental college and Hospital,AMU Campus, Medical Road, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9410693834 |
| Fax |
|
| Email |
sajid.bds.amu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
CHANDANI AGRAWAL |
| Address |
OPD-7, PG Clinic, Department of Conservative Dentistry And Endodontics, Dr. Ziauddin Ahmad Dental college and Hospital,AMU Campus, Medical Road, Aligarh |
| 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 |
| Chandani Agrawal |
Dr. Ziadduin Ahmad Dental College |
OPD-7, PG Clinic, Department of Conservative Dentistry And Endodontics, Dr. Ziauddin Ahmad Dental college and Hospital,AMU Campus, Medical Road, Aligarh
Aligarh
UTTAR PRADESH |
8218308973
chandani.agr2297@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 |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combination of ibuprofen and Dexamethasone |
this group of patient will have ibuprofen and dexamethasone in combination |
| Intervention |
Dexamethasone |
this group of patient will have dexamethasone tablet 1hr prior to treatment |
| Intervention |
Ibuprofen |
this group of patients will have ibuprofen 1 hr before the start of treatment |
| Comparator Agent |
Placebo |
this group of patient will recieve multivitamin tablets |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients experiencing moderate to severe pain and a prolonged response to pulp sensibility testing.
2. Should have a normal radiographic appearance.
3.Should not have taken any analgesics for at least 12 hours before.
4. Systemically healthy patients |
|
| ExclusionCriteria |
| Details |
1. patients under 18 years old.
2. Patients with allergies and hypersensitivity to medications.
3. Pregnant or nursing women.
4. Immunocompromised patients.
5. Patients unable to give consent will be excluded from the study
|
|
|
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 |
| pain assessment |
pain assessment pre-operative, during access cavity, and during instrumentaion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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)
|
20/05/2025 |
| 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
|
Symptomatic irreversible pulpitis is a painful condition requiring root canal treatment, often characterized by heightened inflammatory mediator levels like prostaglandins (PGs) and leukotrienes. These mediators reduce the efficacy of local anesthetics, including inferior alveolar nerve block (IANB), by lowering the pain threshold and causing resistance to anesthesia. Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and glucocorticoids like dexamethasone have shown promise in improving anesthetic outcomes by suppressing these mediators. Ibuprofen, at higher doses, has been effective in enhancing IANB success, while dexamethasone dual action on the COX and LOX pathways suggests its potential for similar benefits. However, limited research exists on the optimal dosages and combined effects of these drugs in improving anesthesia in cases of irreversible pulpitis. This study aims to evaluate the dose-dependent effects of ibuprofen and dexamethasone, individually and in combination, as oral premedications to enhance IANB success rates. It also seeks to identify the optimal dosages and assess the synergistic effects of these medications compared to a placebo, focusing on improving pain management during endodontic treatment. |