Piroxicam Premedication for Postendodontic Pain in Non-vital Mandibular Molars

July 13, 2019 updated by: Asmaa Fathelrahman Mohamed, Cairo University

Effect of Piroxicam Premedication on Postendodontic Pain in Mandibular Molars With Non-vital Pulp: A Randomized Controlled Trial

The aim of the study is to evaluate the effect of piroxicam (20mg) compared to placebo on post-endodontic pain of single-visit endodontic treatment of non-vital mandibular molars.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  • Patients will be clinically and radiographically examined and their eligibility will be assessed. Eligible patients will be treated in one visit.
  • Patients will be randomly assigned to one of 2 groups: experimental group (premedication with 20 mg of piroxicam) and the control group (premedication with placebo). Each participant will receive a standard inferior alveolar nerve block injection. After endodontic treatment, patients will be given postoperative instructions and informed, in case of pain, to receive ibuprofen 200 mg as rescue medication.
  • Postendodontic pain intensity and incidence at the different pain categories (No, mild, moderate, severe) will be assessed 6, 12, 24, 48, 72 hours and 7 days postoperatively using a 0-10 numerical rate scale (NRS). Analgesic intake throughout the 7 days will be recorded.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients aging between 18-50 years old
  2. Patients with mandibular molar with non-vital pulp.
  3. Systemically- healthy patients (ASA I or II).
  4. Patients who agree to attend for recall appointments and provide a written consent.

Exclusion Criteria:

  1. Pregnant or lactating female patients.
  2. Patients allergic to piroxicam.
  3. History of peptic ulceration.
  4. Periapical abscess, fistula.
  5. Non-restorable teeth.
  6. Moderate or severe marginal periodontitis i.e. pocket probe>3mm.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
placebo
Drug: Placebo
placebo
Experimental: Piroxicam drug
20 mg piroxicam
Drug: Piroxicam
20mg piroxicam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postendodontic pain using a pain-measuring scale
Time Frame: 6 hours
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 6 hours after the first visit
6 hours
Postendodontic pain using a pain-measuring scale
Time Frame: 12 hours
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 12 hours after the first visit
12 hours
Postendodontic pain using a pain-measuring scale
Time Frame: 24 hours
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 24 hours after the first visit
24 hours
Postendodontic pain using a pain-measuring scale
Time Frame: 48 hours
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 48 hours after the first visit
48 hours
Postendodontic pain using a pain-measuring scale
Time Frame: 72 hours
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 72 hours after the first visit
72 hours
Postendodontic pain using a pain-measuring scale
Time Frame: 7 days
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 7 days after the first visit
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic medication intake incidence
Time Frame: 7 days
Analgesic medication intake incidence (Yes/No) as a rescue medication in case postoperative pain persisted after the sham medication intake.
7 days

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Asmaa FE Mohamed, B.D.S, Cairo University

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 (Anticipated)

September 1, 2019

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

June 25, 2019

First Submitted That Met QC Criteria

June 25, 2019

First Posted (Actual)

June 26, 2019

Study Record Updates

Last Update Posted (Actual)

July 16, 2019

Last Update Submitted That Met QC Criteria

July 13, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-CU-2019-06-13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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