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the Effect of Preoperative Sodium Ibuprofen on Postoperative Endodontic Pain

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04964622
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
7
Anticipated Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to clinically compare post-operative pain levels after administration of preoperative single dose of sodium ibuprofen versus placebo for patient with symptomatic irreversible pulpitis related to mandibular molar teeth.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

Oral pharmacologic agents have been the primary option, and the use of drugs has increased exponentially. Many pharmacological agents have been used to manage endodontic pain, including Non-steroidal Anti-inflammatory Drugs (NSAIDs),.administration of NSAIDs before root canal treatment will reduce inflammatory process before it begins. NSAIDs are widely used to control post endodontic pain They act by blocking the activity of cyclooxygenase (COX 1 and 2) enzyme. In human dental pulps with irreversible pulpitis, a higher level of expression of COX 2.In cases of irreversible pulpitis NSAIDS can be administered preoperatively since they reduce the level of prostaglandinE2(PGE2) which is responsible for sensitization of nociceptors. Ibuprofen is one of the most commonly used NSAIDs and a potent inhibitor of prostaglandin (PG) synthesis that can manage various pain types and has anti-inflammatory activity. Enhancements in ibuprofen acid's pharmacokinetics have led to the development of ibuprofen salts with a faster dissolution rate and onset of action. These ibuprofen salts.Fast acting ibuprofen like Sodium ibuprofen delivers maximum plasma drug concentrations at about 30-40 min, compared with around 90-120 min for standard ibuprofen acid formulations

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
patient with symptomatic irriversible pulpitispatient with symptomatic irriversible pulpitis
Masking:
Double (Participant, Care Provider)
Masking Description:
drug will be put in sealed envelop and assistant supervisor will generate random sequence
Primary Purpose:
Prevention
Official Title:
Effect of Preoperative Single Dose of Sodium Ibuprofen Versus Placebo on Post-operative Pain for Patient With Symptomatic Irreversible Pulpitis Related to Mandibular Molar Teeth: Double Blind Randomized Controlled Trial
Actual Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: nurofen

sodium ibuprofen 1 tablet (256) 30 minutes before treatment administered once (oral)

Drug: nurofen
tablet
Other Names:
  • sodium ibuprofen

    		•
    Placebo Comparator: placebo

    starch tablet 30 minutes before treatment administered once (oral)

    Drug: nurofen
    tablet
    Other Names:
  • sodium ibuprofen

    		•

    Outcome Measures

    Primary Outcome Measures

    1. postoperative pain [Post-operative pain will be assessed immediately after treatment ,at 6 hours, at 12 hours, at 24 hours and 48 hours]

      pain will be measured by visual an alogue scale). It is a line numbered from 0-10. Patients will be asked to choose the mark that represented their level of pain from 0 to 10. Pain level will be assigned as follow: 0, "no pain" 1-3, "mild pain" 4-6, "moderate pain" 7-10, "severe pain" "10" being the most intense pain conceivable.

    Secondary Outcome Measures

    1. need for rescue medication [Amount of analgesics taken by the patient after root canal treatment, up to 48 hours postoperatively]

      Amount of analgesics taken by the patient after root canal treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Patients above 18 years old and below 66.

    • Male or female

    • Patients seeking root canal treatment

    • Mandibular posterior molarteeth with Symptomatic irreversible pulpitis .

    • Spontaneous pain

    • Systematically healthy patient(ASA I,II)

    Exclusion Criteria:

    • Medically compromised patients having significant systemic disorders. (ASA III or IV)

    • History of intolerance to NSAIDS.

    • Patients with two or more adjacent teeth requiring endodontic treatment.

    • External root resorption

    • Internal root resorption

    • Vertical root fracture

    • Periapical lesion

    • Pregnancy

    • Use of ibuprofen in the last 12 hour

    • Bleeding disorder

    • Long term corticosteroid use

    • Mobility Grade II or III.

    • Pocket depth more than 5mm.

    • Previous root canal therapy.

    • Non-restorability

    • Temporomandibular joint (TMJ) problems, bruxism, clenching or traumatic occlusion.

    • Inability to perceive the given instructions.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo University Cairo Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Samah Sobhie Abdalla, principal investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04964622
    Other Study ID Numbers:
    • postoperative endodontic pain
    First Posted:
    Jul 16, 2021
    Last Update Posted:
    Jun 15, 2022
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pulpitis
    Ibuprofen

    Study Results

    No Results Posted as of Jun 15, 2022