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

NCT07281807 | Not Yet Recruiting Phase 4

• 1 other identifier: TUF/IRB/28/2025
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Irreversible Pulpitis With Apical Periodontitis; Symptomatic Apical Periodontitis

Outcome Measures

Primary Outcomes (1)

• pain after single visit root canal treatment

  pain score on visual analogue scale

  48 hours

Study Arms (2)

Group A: piroxicam

EXPERIMENTAL

Group A: patients will be given piroxicam 20mg as premedication

Drug: piroxicam 20mg

Group B: prednisolone

ACTIVE COMPARATOR

Group B: patients will be given prednisolone 20mg as premedication

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

Interventions

Group B: patients will be given prednisolone 20mg as premedication DRUG

Group B: patients will be given prednisolone 20mg as premedication

Group B: prednisolone

piroxicam 20mg DRUG

Group A: patients will be given piroxicam 20mg as premedication

Group A: piroxicam

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• RANA AHMAD: lead

Related Publications (2)

• 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 RESULT

• 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.

  RESULT

MeSH Terms

Interventions

Premedication; Piroxicam

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Thiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

rana ahmad, B.D.S., F.C.P.S.

CONTACT

+923335990799; ranam_ahmad@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 15, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12