search
Back to results

Celebrex Premedication in Teeth With Symptomatic Irreversible Pulpitis

Primary Purpose

Pulpitis

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

About this trial

This is an interventional treatment trial for Pulpitis

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Medically free patients
  • Patients able to understand Visual Analogue Scale and sign the informed conset

Mandibular molar teeth with:

  • Preoperative sharp pain
  • Vital pulp tissue
  • Normal peripaical radiographic appearance or slight widening of the lamina dura

Exclusion Criteria:

  • Patients allergic to NSAIDS
  • Pregnant females
  • Patients having significant systemic disorder
  • Patients with psychological disturbances
  • Patients with bruxism or clenching

Teeth that have:

  • Associated with swelling or fistulous tract
  • Acute or chronic periapical abscess
  • Greater than grade I mobility
  • Periodontitis
  • No possible restorability
  • previous endodontic treatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Celebrex premedication

    Placebo tablets

    Arm Description

    Celebrex is a NSAID with selective COX-2 inhibition properties, is given as an intervention to assess the pain

    placebo tablets to compare the efficacy of Celebrex on the intra-operative and post-operative pain accompanying endodontic treatment of teeth with irreversible pulpits

    Outcomes

    Primary Outcome Measures

    pain intensity (intra-operative pain)
    pain intensity during endodontic treatment, measured by Visual Analogue Scale (pain scale)

    Secondary Outcome Measures

    alleviation of pain severity
    severity of pain is measured by Visual Analogue Scale
    number of analgesic tablets taken by the patient after endodontic treatment
    counting the number of analgesic tablets taken by the patient after the treatment

    Full Information

    First Posted
    November 1, 2017
    Last Updated
    November 9, 2017
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03339544
    Brief Title
    Celebrex Premedication in Teeth With Symptomatic Irreversible Pulpitis
    Official Title
    Effect of Celebrex Pre-medication on the Intra and Post-treatment Endodontic Pain in Teeth With Symptomatic Irreversible Pulpitis: Double Blind Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2017 (Anticipated)
    Primary Completion Date
    December 1, 2018 (Anticipated)
    Study Completion Date
    December 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
    Assessing the efficacy of Celebrex premedication on pain during and after endodontic treatment in teeth with symptomatic irreversible pulpits
    Detailed Description
    Owing to the painful nature of endodotnic treatment in teeth with irreversible pulpits, administration of an analgesic and anti-inflammatory could help to lessen the perception of pain, hence decreasing the patient apprehension. Previous clinical trials have shown that the use of NSAIDS as a premedication prior to endodontic treatment was effective in reducing the pain and increasing the anesthetic success, since as high as 80% of the patients with pre-operative pain experience pain after endodontic treatment. In this study, Celebrex (Celecoxib) 200mg will be given to the patients 1 hour before initiation of the treatment, and its effect on reducing the pain will be compared with a placebo. Celebrex being a selective COX-2 inhibitor, it will spare the physiological tissue prostaglandin production while inhibiting the inflammatory prostaglandin production thus allow for effective analgesia with fewer side effects than Non-Selective NSAIDS (nsNSAIDS).

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    46 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Celebrex premedication
    Arm Type
    Experimental
    Arm Description
    Celebrex is a NSAID with selective COX-2 inhibition properties, is given as an intervention to assess the pain
    Arm Title
    Placebo tablets
    Arm Type
    Placebo Comparator
    Arm Description
    placebo tablets to compare the efficacy of Celebrex on the intra-operative and post-operative pain accompanying endodontic treatment of teeth with irreversible pulpits
    Intervention Type
    Drug
    Intervention Name(s)
    Celebrex premedication
    Other Intervention Name(s)
    Celecoxib
    Intervention Description
    celebrex (celecoxib) 200mg is a non-steroidal anti-infalmmatory drug with selective COX-2 inhibition.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    placebo is given as a tablet before initiation of endodontic treatment
    Primary Outcome Measure Information:
    Title
    pain intensity (intra-operative pain)
    Description
    pain intensity during endodontic treatment, measured by Visual Analogue Scale (pain scale)
    Time Frame
    1 hour after administration of the drug up to 2 hours till the end of endodontic treatment
    Secondary Outcome Measure Information:
    Title
    alleviation of pain severity
    Description
    severity of pain is measured by Visual Analogue Scale
    Time Frame
    24 hours
    Title
    number of analgesic tablets taken by the patient after endodontic treatment
    Description
    counting the number of analgesic tablets taken by the patient after the treatment
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Medically free patients Patients able to understand Visual Analogue Scale and sign the informed conset Mandibular molar teeth with: Preoperative sharp pain Vital pulp tissue Normal peripaical radiographic appearance or slight widening of the lamina dura Exclusion Criteria: Patients allergic to NSAIDS Pregnant females Patients having significant systemic disorder Patients with psychological disturbances Patients with bruxism or clenching Teeth that have: Associated with swelling or fistulous tract Acute or chronic periapical abscess Greater than grade I mobility Periodontitis No possible restorability previous endodontic treatment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yousra Khaled
    Phone
    +201003040660
    Email
    yousra.aly28@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Geraldine Ahmed
    Phone
    +201226322227
    Email
    geraldineahmed@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    15892672
    Citation
    Lee Y, Rodriguez C, Dionne RA. The role of COX-2 in acute pain and the use of selective COX-2 inhibitors for acute pain relief. Curr Pharm Des. 2005;11(14):1737-55. doi: 10.2174/1381612053764896.
    Results Reference
    background
    PubMed Identifier
    26952243
    Citation
    Lapidus D, Goldberg J, Hobbs EH, Ram S, Clark GT, Enciso R. Effect of premedication to provide analgesia as a supplement to inferior alveolar nerve block in patients with irreversible pulpitis. J Am Dent Assoc. 2016 Jun;147(6):427-37. doi: 10.1016/j.adaj.2016.01.006. Epub 2016 Mar 4.
    Results Reference
    result

    Learn more about this trial

    Celebrex Premedication in Teeth With Symptomatic Irreversible Pulpitis

    We'll reach out to this number within 24 hrs