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Comparison Between Intraligamentary Piroxicam and Articaine

Primary Purpose

Pulpitis - Irreversible

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Intra-ligamentary Piroxicam
Intra-ligamentary Articaine
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulpitis - Irreversible

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy and medically free patients.
  • Acute symptomatic irreversible pulpitis of the mandibular first or second molar teeth.
  • Vital teeth with no history of previous root canal treatment.
  • Teeth that could be treated endodontically in single visit.
  • Teeth with normal periodontium, not sensitive to percussion with no periapical radiolucency.
  • Patients able to understand numerical rating scale and sign the informed consent.

Exclusion Criteria:

  • Known hypersensitivity to piroxicam.
  • Pregnancy or lactation.
  • Asthma or allergy to other anti-inflammatory drugs.
  • History of peptic ulceration.
  • Teeth associated with swelling or fistulous tract, acute or chronic periapical abscess.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intra-ligamentary Piroxicam

    Intra-ligamentary Articaine

    Arm Description

    Piroxicam is a long acting potent Non steroidal anti-inflammatory drug (NSAID)with half life of 50 hours in plasma, is given as intervention to assess the pain,will be administered by intra-ligamentary technique by injecting 0.4 milliliter (mL) of 20 milligram (Mg) piroxicam.

    Articaine is a local anesthetic agent, will be administered by intraligamentary technique by injecting 0.4 milliliter (mL) of 4% articaine

    Outcomes

    Primary Outcome Measures

    Alleviation of post-operative pain severity
    the patient will be asked to rate the progress of pain on the NRS and inform the investigator with the results,Primary outcome will be collected by the operator through Numerical Rating Scale (NRS) 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.

    Secondary Outcome Measures

    Intra-operative pain during access cavity preparation and instrumentation which will be measured ny Numerical Rating Scale (NRS)
    the patient will be asked to rate the progress of pain on the NRS and inform the investigator with the results,secondary outcome will be assessed through Numerical Rating Scale (NRS) 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.

    Full Information

    First Posted
    July 16, 2018
    Last Updated
    August 1, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03612323
    Brief Title
    Comparison Between Intraligamentary Piroxicam and Articaine
    Official Title
    Comparative Evaluation of the Efficacy of Intra-ligamentary Injection of 20 Milligram (Mg) Piroxicam Versus 4% Articaine in Management of Endodontic Pain in Patients With Symptomatic Irreversible Pulpitis in Mandibular Molars
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2018 (Anticipated)
    Primary Completion Date
    May 2019 (Anticipated)
    Study Completion Date
    August 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Comparing the efficacy of intra-ligamentary Piroxicam and intra-ligamentary Articaine on pain during and after endodontic treatment of mandibular molars with symptomatic irreversible pulpitis.
    Detailed Description
    Owing to the painful nature of endodontic treatment in teeth with symptomatic irreversible pulpitis and difficulty in achieving effective anesthesia particularly in mandibular molars due to various factors such as different bony landmarks, anatomical variations, needle deflection, accessory innervation, so local anesthesia isn't enough in such cases. Piroxicam is a long-acting potent analgesic non selective oxicams derivative, has a half-life of 50 hrs in the plasma.The onset of action of oral Piroxicam is 2-4 hrs, but it is anticipated that injectable piroxicam could produce more rapid onset of action. It could favourably overcome the intense pain up to 48 hrs following the treatment. It is also postulated that the intraligamentary injection enables the application of anti-inflammatory agents in the periapical intraosseous region. Moreover, intra-ligamentary injection of local anesthesia was reported to be an effective and easy way to control severe pain during endodontic treatment mainly in mandibular teeth which are more difficult than maxillary teeth , thus piroxicam may be effective as an adjuvant drug to support the action of local anesthetics.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulpitis - Irreversible

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intra-ligamentary Piroxicam
    Arm Type
    Experimental
    Arm Description
    Piroxicam is a long acting potent Non steroidal anti-inflammatory drug (NSAID)with half life of 50 hours in plasma, is given as intervention to assess the pain,will be administered by intra-ligamentary technique by injecting 0.4 milliliter (mL) of 20 milligram (Mg) piroxicam.
    Arm Title
    Intra-ligamentary Articaine
    Arm Type
    Active Comparator
    Arm Description
    Articaine is a local anesthetic agent, will be administered by intraligamentary technique by injecting 0.4 milliliter (mL) of 4% articaine
    Intervention Type
    Drug
    Intervention Name(s)
    Intra-ligamentary Piroxicam
    Other Intervention Name(s)
    Feldene
    Intervention Description
    Piroxicam is a long-acting potent analgesic non selective oxicams derivative, has a half-life of 50 hrs in the plasma.The onset of action of oral piroxicam is 2-4 hrs, but it is anticipated that injectable piroxicam could produce more rapid onset of action. It could favourably overcome the intense pain up to 48 hrs following the treatment
    Intervention Type
    Drug
    Intervention Name(s)
    Intra-ligamentary Articaine
    Other Intervention Name(s)
    Articaine
    Intervention Description
    Articaine is a local anesthetic agent , has been reported to be an effective anesthetic in controlling pain during root canal treatment
    Primary Outcome Measure Information:
    Title
    Alleviation of post-operative pain severity
    Description
    the patient will be asked to rate the progress of pain on the NRS and inform the investigator with the results,Primary outcome will be collected by the operator through Numerical Rating Scale (NRS) 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.
    Time Frame
    up to 48 hours
    Secondary Outcome Measure Information:
    Title
    Intra-operative pain during access cavity preparation and instrumentation which will be measured ny Numerical Rating Scale (NRS)
    Description
    the patient will be asked to rate the progress of pain on the NRS and inform the investigator with the results,secondary outcome will be assessed through Numerical Rating Scale (NRS) 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.
    Time Frame
    immediately after injection of the drug up to 2 hours till end of endodontic treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy and medically free patients. Acute symptomatic irreversible pulpitis of the mandibular first or second molar teeth. Vital teeth with no history of previous root canal treatment. Teeth that could be treated endodontically in single visit. Teeth with normal periodontium, not sensitive to percussion with no periapical radiolucency. Patients able to understand numerical rating scale and sign the informed consent. Exclusion Criteria: Known hypersensitivity to piroxicam. Pregnancy or lactation. Asthma or allergy to other anti-inflammatory drugs. History of peptic ulceration. Teeth associated with swelling or fistulous tract, acute or chronic periapical abscess.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lobna Elhadad, student
    Phone
    +201279811117
    Email
    lobna.elhadad@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marwa Bedeir
    Phone
    +201006611104
    Email
    M.bedeir81@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lobna Elhadad, Student
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Comparison Between Intraligamentary Piroxicam and Articaine

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