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

October 10, 2019 updated by: Anum Tanwir , MDS, Dow University of Health Sciences

Effectiveness of Single Dose Pre Medication of Piroxicam and Prednisolone on Post Endodontic Pain After a One Visit Root Canal Treatment. Randomized Trial .

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75500
        • DUHS

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

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  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

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: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Piroxicm is from oxicam family of anti inflammatory drug that inhibits prostaglandin synthesis and effectively lower pain threshold levels
EXPERIMENTAL: Prednisolone
group 3 is given Prednisolone 20mg half an hour before root canal treatment to manage post operative pain.
Drug: prednisolone 20 mg
prednisolone is from steroid family of anti inflammatory drug that inhibit arachidonic acid and effectively lowers the pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post operative pain
Time Frame: 76 hours
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
76 hours

Collaborators and Investigators

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

Sponsor

Dow University of Health Sciences

Investigators

  • Principal Investigator: Anum Tanwir, BDS, Dow University of Health Sciences

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 (ACTUAL)

May 30, 2018

Primary Completion (ACTUAL)

July 15, 2019

Study Completion (ACTUAL)

July 15, 2019

Study Registration Dates

First Submitted

August 19, 2019

First Submitted That Met QC Criteria

October 10, 2019

First Posted (ACTUAL)

October 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 11, 2019

Last Update Submitted That Met QC Criteria

October 10, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dikiohs2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

No

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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