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Efficacy of Preoperative Diclofenac Potassium- Acetaminophen Combination on Anesthetic Success in Patients With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial

Primary Purpose

Symptomatic Irreversible Pulpitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diclofenac potassium- acetaminophen combination
Diclofenac potassium
Placebo
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Irreversible Pulpitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with symptomatic irreversible pulpitis with/without mechanical allodynia
  • Patients with moderato to severe spontaneous pain
  • Mandibular molars
  • Patients with the ability to understand and use the pain scale
  • Patients accepting enrollment in the study

Exclusion Criteria:

  • Patients allergic to any medication or material to be used in the study
  • Pregnant and lactating females
  • Patients taking medications affecting pain perception in the last 12 hours
  • Patients having more than one symptomatic molar in the same quadrant
  • Patients with contributory medical history (ASA > II)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Diclofenac potassium- acetaminophen combination

    Diclofenac potassium

    Placebo

    Arm Description

    Preoperative single dose of diclofenac potassium(50mg)- acetaminophen(1000mg) combination

    Preoperative single dose of diclofenac potassium(50mg)

    Preoperative single dose of placebo

    Outcomes

    Primary Outcome Measures

    Anesthetic success of inferior alveolar nerve block
    Will be recorded by 11 point NRS 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" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain". Success will be defined as no to mild pain.

    Secondary Outcome Measures

    Postoperative pain at 6 hours
    Will be recorded by 11 point NRS 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" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"
    Postoperative pain at 12 hours
    Will be recorded by 11 point NRS 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" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"
    Postoperative pain at 24 hours
    represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"
    Postoperative pain at 48 hours
    represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"
    Postoperative pain at 72 hours
    represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"
    Postoperative pain at 7 days
    represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"

    Full Information

    First Posted
    October 13, 2020
    Last Updated
    October 28, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04593160
    Brief Title
    Efficacy of Preoperative Diclofenac Potassium- Acetaminophen Combination on Anesthetic Success in Patients With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial
    Official Title
    Efficacy of Preoperative Diclofenac Potassium- Acetaminophen Combination on Anesthetic Success in Patients With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2021 (Anticipated)
    Primary Completion Date
    December 2021 (Anticipated)
    Study Completion Date
    March 2022 (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 purpose of this study is to assess the effect of preoperative a single-dose of 50 mg diclofenac potassium- 1000mg acetaminophen combination compared to diclofenac potassium alone or placebo on local anesthetic success and postoperative pain in patients with symptomatic irreversible pulpitis.
    Detailed Description
    Patients with moderate-to-severe preoperative pain are selected. Patients receive either a single-dose of diclofenac potassium (50mg)- acetaminophen (1000mg) combination, diclofenac potassium (50mg) alone or a placebo tablet as a control. All patients will receive the assigned premedication one hour before single-visit root canal treatment. Anesthetic success of inferior alveolar nerve block will be assessed during access and instrumentation. Postoperative endodontic pain is measured at the following time points: 6,12,24,48,72h and 7 days after treatment.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    72 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Diclofenac potassium- acetaminophen combination
    Arm Type
    Experimental
    Arm Description
    Preoperative single dose of diclofenac potassium(50mg)- acetaminophen(1000mg) combination
    Arm Title
    Diclofenac potassium
    Arm Type
    Experimental
    Arm Description
    Preoperative single dose of diclofenac potassium(50mg)
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Preoperative single dose of placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Diclofenac potassium- acetaminophen combination
    Intervention Description
    Preoperative single dose of diclofenac potassium(50mg)- acetaminophen(1000mg) combination
    Intervention Type
    Drug
    Intervention Name(s)
    Diclofenac potassium
    Intervention Description
    Preoperative single dose of diclofenac potassium(50mg)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Preoperative single dose of placebo
    Primary Outcome Measure Information:
    Title
    Anesthetic success of inferior alveolar nerve block
    Description
    Will be recorded by 11 point NRS 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" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain". Success will be defined as no to mild pain.
    Time Frame
    During the treatment
    Secondary Outcome Measure Information:
    Title
    Postoperative pain at 6 hours
    Description
    Will be recorded by 11 point NRS 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" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"
    Time Frame
    6 hours
    Title
    Postoperative pain at 12 hours
    Description
    Will be recorded by 11 point NRS 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" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"
    Time Frame
    12 hours
    Title
    Postoperative pain at 24 hours
    Description
    represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"
    Time Frame
    24 hours
    Title
    Postoperative pain at 48 hours
    Description
    represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"
    Time Frame
    48 hours
    Title
    Postoperative pain at 72 hours
    Description
    represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"
    Time Frame
    72 hours
    Title
    Postoperative pain at 7 days
    Description
    represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with symptomatic irreversible pulpitis with/without mechanical allodynia Patients with moderato to severe spontaneous pain Mandibular molars Patients with the ability to understand and use the pain scale Patients accepting enrollment in the study Exclusion Criteria: Patients allergic to any medication or material to be used in the study Pregnant and lactating females Patients taking medications affecting pain perception in the last 12 hours Patients having more than one symptomatic molar in the same quadrant Patients with contributory medical history (ASA > II)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sovana T. Abd El-Monem
    Phone
    +201005173697
    Email
    sovana.tarek241@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Suzan Amin
    Email
    suzan.wanis@dentistry.cu.edu.eg

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29709297
    Citation
    Nagendrababu V, Pulikkotil SJ, Veettil SK, Teerawattanapong N, Setzer FC. Effect of Nonsteroidal Anti-inflammatory Drug as an Oral Premedication on the Anesthetic Success of Inferior Alveolar Nerve Block in Treatment of Irreversible Pulpitis: A Systematic Review with Meta-analysis and Trial Sequential Analysis. J Endod. 2018 Jun;44(6):914-922.e2. doi: 10.1016/j.joen.2018.02.017. Epub 2018 Apr 27.
    Results Reference
    background
    PubMed Identifier
    17185119
    Citation
    Ianiro SR, Jeansonne BG, McNeal SF, Eleazer PD. The effect of preoperative acetaminophen or a combination of acetaminophen and Ibuprofen on the success of inferior alveolar nerve block for teeth with irreversible pulpitis. J Endod. 2007 Jan;33(1):11-4. doi: 10.1016/j.joen.2006.09.005.
    Results Reference
    background
    PubMed Identifier
    32470370
    Citation
    Al-Rawhani AH, Gawdat SI, Wanees Amin SA. Effect of Diclofenac Potassium Premedication on Postendodontic Pain in Mandibular Molars with Symptomatic Irreversible Pulpitis: A Randomized Placebo-Controlled Double-Blind Trial. J Endod. 2020 Aug;46(8):1023-1031. doi: 10.1016/j.joen.2020.05.008. Epub 2020 May 26.
    Results Reference
    background

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    Efficacy of Preoperative Diclofenac Potassium- Acetaminophen Combination on Anesthetic Success in Patients With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial

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