Comparison of a Prophylactic Intraligamentary Injection of Piroxicam Versus Mepecaine of Post-endodontic Pain

December 27, 2016 updated by: Marwa Gamal Ahmed, Cairo University

Comparison of the Efficacy of Prophylactic Intraligamentary Injection of Piroxicam Versus Mepecaine for Management of Post-endodontic Pain in Posterior Teeth

to evaluate the effect of a single intraligamentary injection of piroxicam on postoperative pain associated with endodontic procedures.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The pain after endodontic treatment is commonly severe in the first 24 hours after treatment, then it will reduce gradually until commonly disappearing after 7-10 days in most cases. Since piroxicam has a half-life of 50 hours in the plasma, it will be effective in controlling the most intense pain which occurs after endodontic treatment It appears that optimal clinical benefits can be achieved by administering drugs such as local anesthetics and NSAIDs before the onset of postoperative pain. Administering these drugs before a surgical or an endodontic procedure may be of benefit for longer procedures or for minimizing peripheral sensitization, which is a result of the cascade of inflammatory mediators that are released by tissue injury and fuel the subsequent inflammatory process

Study Type

Interventional

Enrollment (Anticipated)

26

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

  • Name: Sherif A El khodary, Lecturer
  • Phone Number: 01006609198

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

25 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • Medically free patients

    • Patient's age between 25-50 years.
    • Molar or premolar teeth diagnosed clinically and radiographically with irreversible pulpitis and symptomatic apical periodontitis.
    • Positive patient's acceptance for participation in the study.
    • Sex include both male and female.
    • Patients who can understand Numerical Rating Scale (NRS)
    • Patients able to sign informed consent.

Exclusion Criteria:

  • • Pregnancy or lactation in female patients

    • Medically compromised patients.
    • Patient with multiple teeth that required endodontic treatment to eliminate the possibility of pain referral.
    • Patient with fracture or mobile or mutilated teeth.

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intraligamentary injection of piroxicam

intraligamentary injection Piroxicam is another NSAID that which has the ability for the treatment of pain, fever and inflammation in the body , has a half-life of 50h in the plasma , oral piroxicam reaches a peak concentration in the plasma within 2 to 4 hours .

The needle will be placed in the gingival sulcus at a 30- degree angle to the long axis of the tooth then apical pressure is applied until the needle wedged into the periodontal ligament between the tooth and the alveolar crest of the bone
Procedure: intraligamentary injection piroxicam

intraligamentary injection Piroxicam is another NSAID that which has the ability for the treatment of pain, fever and inflammation in the body , has a half-life of 50h in the plasma , oral piroxicam reaches a peak concentration in the plasma within 2 to 4 hours .

The needle will be placed in the gingival sulcus at a 30- degree angle to the long axis of the tooth then apical pressure is applied until the needle wedged into the periodontal ligament between the tooth and the alveolar crest of the bone
Active Comparator: Intraligamentary mepevacaine
mepevacaine is an anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to brain . It is also used as an anesthetic for dental procedures.
Procedure: Intraligamentary mepevacaine
mepevacaine is an anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to brain . It is also used as an anesthetic for dental procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The degree of postoperative pain at 6, 12, 24 and 48 postoperative hours which will be measured by Numeric Rate Scale , where the patient will be asked to rate the progress of pain on the NRS and inform the investigator with the results.
Time Frame: up to 48 hours
Primary outcome will be collected by the operator through Numerical Rating Scale (NRS)20 which is an 11-point scale consisting of numbers from 0 through 10; 0 reading represents "no pain" , 1- 3 readings represent "mild pain" , 4- 6 readings represent "moderate pain" , 7- 10 readings represent "severe pain" No or mild pain will be considered as success while moderate or severe pain will be regarded as failure.
up to 48 hours

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: marwa ga ahmed, student, Department of endodontics - Faculty of Oral and Dental medicine - CU

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

December 1, 2016

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

December 15, 2016

First Submitted That Met QC Criteria

December 27, 2016

First Posted (Estimate)

December 30, 2016

Study Record Updates

Last Update Posted (Estimate)

December 30, 2016

Last Update Submitted That Met QC Criteria

December 27, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • piroxicam _ Mepecaine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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