Comparison of the Pain Levels of Single-Dose Premedication With Piroxicam and Prednisolone on Post-Endodontic Pain in Single-Visit Root Canal Treatment of Premolars

December 2, 2025 updated by: RANA AHMAD
To compare the post operative mean pain scores by administering single-dose preoperative piroxicam and prednisolone in patients of irreversible pulpitis with symptomatic apical periodontitis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy patient ranging between 18-40 years
  • Having at least one premolar with diagnosis of symptomatic irreversible pulpitis according to history, examination and radiographs.
  • Teeth having mature apex confirmed by periapical radiographs.

Exclusion Criteria:

  • History of systemic disorders including HIV, Hepatitis

    • Pregnancy (As per Medical record/ Verbally)
    • Patient using medication such as analgesics or anti-inflammatory drugs
    • Patient allergic to lignocaine, piroxicam and prednisolone
    • Tooth not suitable for restoration
    • Periodontal probing depth ≥ 4mm
    • Retreatment cases
    • Patients having calcified canals assessed by radiographic findings

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: piroxicam
Group A: patients will be given piroxicam 20mg as premedication
Drug: piroxicam 20mg
Group A: patients will be given piroxicam 20mg as premedication
Active Comparator: Group B: prednisolone
Group B: patients will be given prednisolone 20mg as premedication
Drug: Group B: patients will be given prednisolone 20mg as premedication
Group B: patients will be given prednisolone 20mg as premedication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain after single visit root canal treatment
Time Frame: 48 hours
pain score on visual analogue scale
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RANA AHMAD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Actual)

December 15, 2025

Study Record Updates

Last Update Posted (Actual)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUF/IRB/28/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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