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Not yet recruiting NCT07281807

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

Phase IV Interventional Irreversible Pulpitis With Apical Periodontitis Symptomatic Apical Periodontitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Group B: patients will be given prednisolone 20mg as premedication, piroxicam 20mg.
Who it may be relevant to
Registry conditions: Irreversible Pulpitis With Apical Periodontitis, Symptomatic Apical Periodontitis. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Drug Group B: patients will be given prednisolone 20mg as premedication
    Group B: patients will be given prednisolone 20mg as premedication
  • Drug piroxicam 20mg
    Group A: patients will be given piroxicam 20mg as premedication

Primary outcome measures

  • pain after single visit root canal treatment [Time frame: 48 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Single group
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Vatankhah M, Zargar N, Naseri M, Salem S, Baghban AA, Etemadi A, Dianat O. Analgesic Efficacy of Ibuprofen and Diclofenac Potassium on Postoperative Endodontic Pain in Maxillary and Mandibular First Molars with Irreversible Pulpitis: A Randomised Controlled Trial. Eur Endod J. 2023 Mar;8(2):133-139. doi: 10.14744/eej.2022.45238. PMID 37010198
  • Benkhalil AM, Rmdan GA. Effect of Prednisolone Premedication on Postoperative Pain after Single Visit Endodontic Therapy: A Randomized Controlled Trial. Sch J App Med Sci. 2022;8:1219-26.

Identifiers

NCT: NCT07281807 · TUF/IRB/28/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗