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Piroxicam Premedication for Postendodontic Pain in Non-vital Mandibular Molars

Primary Purpose

Non-Vital Tooth

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Piroxicam
Placebo
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Non-Vital Tooth focused on measuring Piroxicam, Postendodontic pain, analgesic intake

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Piroxicam drug

    Placebo

    Arm Description

    20 mg piroxicam

    placebo

    Outcomes

    Primary Outcome Measures

    Postendodontic pain using a pain-measuring scale
    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
    Postendodontic pain using a pain-measuring scale
    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
    Postendodontic pain using a pain-measuring scale
    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
    Postendodontic pain using a pain-measuring scale
    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
    Postendodontic pain using a pain-measuring scale
    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
    Postendodontic pain using a pain-measuring scale
    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

    Secondary Outcome Measures

    Analgesic medication intake incidence
    Analgesic medication intake incidence (Yes/No) as a rescue medication in case postoperative pain persisted after the sham medication intake.

    Full Information

    First Posted
    June 25, 2019
    Last Updated
    July 13, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03998826
    Brief Title
    Piroxicam Premedication for Postendodontic Pain in Non-vital Mandibular Molars
    Official Title
    Effect of Piroxicam Premedication on Postendodontic Pain in Mandibular Molars With Non-vital Pulp: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2019 (Anticipated)
    Primary Completion Date
    September 1, 2020 (Anticipated)
    Study Completion Date
    December 1, 2020 (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
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Vital Tooth
    Keywords
    Piroxicam, Postendodontic pain, analgesic intake

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Parallel Assignment Type: Two arm, parallel, randomized clinical trial. Allocation ratio: 1:1 Framework: Superiority.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    The study will be participant and operator-blind where the participant and operator will not know the intervention done.
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Piroxicam drug
    Arm Type
    Experimental
    Arm Description
    20 mg piroxicam
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Piroxicam
    Intervention Description
    20mg piroxicam
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    placebo
    Primary Outcome Measure Information:
    Title
    Postendodontic pain using a pain-measuring scale
    Description
    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
    Time Frame
    6 hours
    Title
    Postendodontic pain using a pain-measuring scale
    Description
    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
    Time Frame
    12 hours
    Title
    Postendodontic pain using a pain-measuring scale
    Description
    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
    Time Frame
    24 hours
    Title
    Postendodontic pain using a pain-measuring scale
    Description
    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
    Time Frame
    48 hours
    Title
    Postendodontic pain using a pain-measuring scale
    Description
    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
    Time Frame
    72 hours
    Title
    Postendodontic pain using a pain-measuring scale
    Description
    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
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    Analgesic medication intake incidence
    Description
    Analgesic medication intake incidence (Yes/No) as a rescue medication in case postoperative pain persisted after the sham medication intake.
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients aging between 18-50 years old Patients with mandibular molar with non-vital pulp. Systemically- healthy patients (ASA I or II). Patients who agree to attend for recall appointments and provide a written consent. Exclusion Criteria: Pregnant or lactating female patients. Patients allergic to piroxicam. History of peptic ulceration. Periapical abscess, fistula. Non-restorable teeth. Moderate or severe marginal periodontitis i.e. pocket probe>3mm.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Asmaa FE Mhamed, B.D.S
    Phone
    +201273035494
    Email
    logainali89@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Suzan AW Amin, Ph.D
    Email
    swaness@rocketmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Asmaa FE Mohamed, B.D.S
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30820083
    Citation
    Konagala RK, Mandava J, Pabbati RK, Anupreeta A, Borugadda R, Ravi R. Effect of pretreatment medication on postendodontic pain: A double-blind, placebo-controlled study. J Conserv Dent. 2019 Jan-Feb;22(1):54-58. doi: 10.4103/JCD.JCD_135_18.
    Results Reference
    background
    PubMed Identifier
    27563175
    Citation
    Joshi N, Mathew S, George JV, Hegde S, Bhandi S, Madhu KS. Comparative evaluation of the efficacy of two modes of delivery of Piroxicam (Dolonex((R))) for the management of postendodontic pain: A randomized control trial. J Conserv Dent. 2016 Jul-Aug;19(4):301-5. doi: 10.4103/0972-0707.186454.
    Results Reference
    background
    PubMed Identifier
    14606784
    Citation
    Nekoofar MH, Sadeghipanah M, Dehpour AR. Evaluation of meloxicam (A cox-2 inhibitor) for management of postoperative endodontic pain: a double-blind placebo-controlled study. J Endod. 2003 Oct;29(10):634-7. doi: 10.1097/00004770-200310000-00005.
    Results Reference
    background

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    Piroxicam Premedication for Postendodontic Pain in Non-vital Mandibular Molars

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