| CTRI Number |
CTRI/2025/12/098787 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of Pain-Relieving Medicines on Tooth Sensibility over Time in People with Dental Pain |
|
Scientific Title of Study
|
Comparative Evaluation of the Analgesic Effect of various Premedications on Pulpal Sensibility Tests at Different Time Intervals in Patients with Endodontic Pain: A 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 |
Dr Vaishnavi |
| Designation |
PG student |
| Affiliation |
SGT University |
| Address |
Room no 204 Department of conservative Dentistry And Endodontics, Budhera, Faculty of Dental Sciences, SGT University, Gurugram Badli road, Gurugram 1220505
Gurgaon
HARYANA
122505
India |
| Phone |
09350135550 |
| Fax |
|
| Email |
vaishnavi.saini18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumeet Sharma |
| Designation |
Head of Department |
| Affiliation |
SGT University |
| Address |
Room no 204 Department of conservative Dentistry And Endodontics, Budhera, Faculty of Dental Sciences, SGT University, Gurugram Badli road, Gurugram 1220505
Gurgaon
HARYANA
122505
India |
| Phone |
9873122335 |
| Fax |
|
| Email |
drsharma.endo_fdsc@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumeet Sharma |
| Designation |
Head of Department |
| Affiliation |
SGT University |
| Address |
Room no 204 Department of conservative Dentistry And Endodontics, Budhera, Faculty of Dental Sciences, SGT University, Gurugram Badli road, Gurugram 1220505
Gurgaon
HARYANA
122505
India |
| Phone |
9873122335 |
| Fax |
|
| Email |
drsharma.endo_fdsc@sgtuniversity.org |
|
|
Source of Monetary or Material Support
|
| Faculty of Dental Science, SGT University, Gurugram Badli Road, Gurugram 122505, Haryana, India |
|
|
Primary Sponsor
|
| Name |
SGT University |
| Address |
Room no. 204 Department of Conservative Dentistry And Endodontics, Budhera, Faculty of Dental Science, SGT University, Gurugram Badli Road, Gurugram 122505 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vaishnavi |
Shree Guru Gobind Singh Tricentenary University |
B Block, Faculty of Dental Sciences, Room No. 204, Department of Conservative Dentistry and Endodontics
Gurgaon
HARYANA
Gurgaon
HARYANA |
9350135550
vaishnavi.saini18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethics Committee-SGT Dental College, Hospital and Research Institute(IEC-SGTDCHRI) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A499||Bacterial infection, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
combination of Ibuprofen (400 mg) and
Paracetamol/Acetaminophen (325 mg) (Combiflam) |
patient will be given this combination of medication after confirming diagnosis of SIP. Pain will then be assessed after 20, 40 and 60 minutes of medication. |
| Comparator Agent |
Ketorolac Tromethamine (Ketorol DT) |
Patient will be given this medication after confirming diagnosis of SIP. Pain will then be assessed after 20, 40 and 60 minutes of medication. |
| Comparator Agent |
placebo (glucose) |
Patient will be given glucose tablet after confirming diagnosis of SIP. Pain will then be assessed after 20, 40 and 60 minutes of medication. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Chief complaints should include cold/hot drinks cause lingering pain.
2. Actively experiencing moderate to severe pain
3. Positive response to cold testing with Endo ice.
4. Mature permanent vital mandibular molar.
Systemically healthy patients.
•Teeth having sufficient tooth structure for adequate isolation.
•No history of previous endodontic therapy.
•No history of trauma to the involved tooth.
|
|
| ExclusionCriteria |
| Details |
1. Patients who have a positive history of analgesic intake within past 3 days.
2. Patients with periapical lesion.
3. Patients who have a positive history of antibiotics intake in the last month.
4. Periodontally compromised teeth.
•Patients with known history of allergy to the drugs in study.
•Diabetic, immunocompromised patients, pregnant, lactating females.
•Calcified roots.
•Neurologic patients.
•Psychiatric patients who are not able to rate the pain on scale.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of combination of Ibuprofen (400 mg) and Paracetamol/Acetaminophen(325 mg) on Electric pulp testing and cold test
|
at intervals of 20 minutes, 40 minutes,60 minutes
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of Ketorolac tromethamine (20 mg) on Electric pulp testing and cold test |
at intervals of 20 minutes, 40 minutes,60 minutes
|
| To compare the effect of Ibuprofen (400 mg) and Paracetamol/Acetaminophen(325 mg), Ketorolac tromethamine(20mg) on cold test and Electric pulp testing |
at intervals of 20 minutes, 40 minutes,60 minutes |
| o identify an analgesic that is more effective for pain relief during diagnostic tests |
at intervals of 20 minutes, 40 minutes,60 minutes
|
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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
|
Introduction:
Accurate diagnosis of symptomatic irreversible pulpitis (SIP) requires correlating patient-reported symptoms with clinical findings through diagnostic tests such as cold test and electric pulp testing (EPT). However, premedication with analgesics may influence test outcomes and pain perception, which has not been extensively evaluated.
Aim:
To evaluate the effect of ibuprofen (400 mg) + paracetamol/acetaminophen (325 mg), and ketorolac tromethamine (20 mg) as premedication on cold test and EPT responses in patients with endodontic pain.
Materials and Methodology:
This prospective, randomized, double-blind, placebo-controlled clinical trial will include 120 patients diagnosed with SIP. Baseline pain will be recorded using the Heft-Parker Visual Analog Scale (HP-VAS). Patients will then be randomly allocated into three groups (n = 40 each):
-
Group A: Ibuprofen (400 mg) + Paracetamol (325 mg) (Combiflam)
-
Group B: Ketorolac Tromethamine (20 mg) (Ketorol DT)
-
Group C: Placebo (glucose)
Capsules were identical in appearance, coded, and dispensed by a person not involved in the trial to ensure allocation concealment. Cold test and EPT will be performed on the affected tooth, adjacent tooth, and contralateral tooth at 20, 40, and 60 minutes after administration. EPT will be carried out with a toothpaste-coated electrode placed on the buccal surface, and patients will indicate the first definite sensation. Cold testing will be done with Endo Ice on a large cotton pellet applied to intact tooth structure. After each test, patients will record their pain levels on the HP-VAS.
Expected Outcomes:
The study seeks to determine whether premedication significantly alters diagnostic test responses and pain intensity compared with placebo. The findings may provide clinical evidence for optimizing analgesic premedication protocols in endodontic patients, improving both diagnostic reliability and patient comfort |