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

NCT ID: NCT07281807

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Irreversible Pulpitis With Apical Periodontitis Symptomatic Apical Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group A: piroxicam

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

Group Type EXPERIMENTAL

piroxicam 20mg

Intervention Type DRUG

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

Group B: prednisolone

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Interventions

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

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

Intervention Type DRUG

piroxicam 20mg

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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RANA AHMAD

OTHER

Sponsor Role lead

Responsible Party

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RANA AHMAD

Dr

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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

Role: CONTACT

+923335990799

References

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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.

Reference Type RESULT
PMID: 37010198 (View on PubMed)

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.

Reference Type RESULT

Other Identifiers

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TUF/IRB/28/2025

Identifier Type: -

Identifier Source: org_study_id

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