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CompletedNCT04124822Updated Oct 11, 2019

Effectiveness if Premedication With Single Dose Piroxicam and Prednisolone After a Single Visit Root Canal Treatment .

A Phase 2/3 interventional study of Piroxicam 20 mg and prednisolone 20 mg in Post-operative Endodontic Pain, sponsored by Dow University of Health Sciences. Completed at 1 site in Pakistan. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-10-11.

Sponsored by Dow University of Health Sciences · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled May 2018, registered Aug 2019).
Phase
Phase 2/3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study summary

Two drugs (Piroxicam and Prednisolone)are being compared for post operative endodontic pain after a single visit root canal treatment for 74 hours.

Read the detailed description

To evaluate effectiveness of single dose premedication with piroxicam(20mg) and prednisolone(20mg) on post endodontic pain after a single visit root canal treatment .

patient will be recalled every day for 4 days to know the pain scale using visual analogue scale .

02

Conditions studied

  • Post-operative Endodontic Pain
03

In context

Lead sponsor

Dow University of Health Sciences is the lead sponsor of 170 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patient ages from 20-40 years(28).
  2. Single rooted tooth with symptomatic irreversible pulpitis.
  3. With no analgesic or anti-inflammatory drug taken within a week period before procedure.

Exclusion criteria

Exclusion Criteria:

  1. Patients presenting with any systemic disease
  2. Patients already taking premedication for endodontic pain.
  3. Pregnant or lactating patients.
  4. Multirooted teeth.
  5. Teeth with Pulpal necrosis.
  6. Previously treated or initiated root canal treatment.
  7. Patient presenting with allergy due to drug
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
60 participants (actual)

Study arms

  • No intervention
    control

    group 1 , is no intervention group in which root canal procedure will be done without drug as ideal protocol .

  • Experimental
    Piroxicam

    group 2 is given Piroxicam 20 mg half an hour before root canal treatment to manage post operative pain.

    Drug: Piroxicam 20 mg

  • Experimental
    Prednisolone

    group 3 is given Prednisolone 20mg half an hour before root canal treatment to manage post operative pain.

    Drug: prednisolone 20 mg

Interventions

  • DrugPiroxicam 20 mg

    Piroxicm is from oxicam family of anti inflammatory drug that inhibits prostaglandin synthesis and effectively lower pain threshold levels

  • Drugprednisolone 20 mg

    prednisolone is from steroid family of anti inflammatory drug that inhibit arachidonic acid and effectively lowers the pain

06

What researchers measure

Primary outcomes

  1. post operative pain

    post operative pain will be measured after single visit endodontic treatment using visual analog scale with readings 1 to 10 from 24 hours till 76 hours

    Time frame: 76 hours

07

Study locations

1 site
  • DUHS
    Karachi, Sindh 75500, Pakistan
08

References and documents

Publications

  • Tanwir A, Ahmed S, Akhtar H, Wahid U, Shakoor Abbasi M, Ahmed N. Effectiveness of Single Dose Premedication of Piroxicam and Prednisolone on Post Endodontic Pain in One Visit Root Canal Treatment: A Randomized Clinical Trial. Eur Endod J. 2022 Oct;7(3):187-192. doi: 10.14744/eej.2022.24119. PubMed 36217645 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04124822
Lead sponsor
Dow University of Health Sciences
Responsible party
Anum Tanwir , MDS (MDS trainee (operative dentistry), Dow University of Health Sciences) — Principal investigator
First posted
Oct 11, 2019
Start date
May 30, 2018
Primary completion
Jul 15, 2019
Completion
Jul 15, 2019
Last update
Oct 11, 2019

Study contacts

Anum Tanwir, BDS
principal investigator · Dow University of Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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