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Evaluation of Post-operative Pain and Expression of IL-8 Using Ketolac or Cryoirrigation as a Final Flush in Single Visit Endodontic Treatment in Teeth With Symptomatic Irreversible Pulpitis and Apical Periodontitis.Randomized Clinical Trial.

Primary Purpose

Post-operative Pain

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Ketorolac Tromethamine
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain

Eligibility Criteria

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

Inclusion Criteria:

  • - Medically free patients
  • Age between 18-40 years old
  • Males or females
  • Participants able to understand Visual Analogue Scale (the pain chart diary) and sign the informed consent ( Appendix I,II).
  • Mandibular permanent molar teeth:

    • Diagnosed clinically with symptomatic irreversible pulpitis associated with apical periodontitis.
    • Presence of spontaneous pain and sharp pain to cold tester (ethyl-chloride) that lingers after removal of the stimulus compared to the contra-lateral tooth
    • Tenderness to percussion with normal periapical radiographic appearance or slight widening of the lamina dura

Exclusion Criteria:

  • - Participants allergic to NSAIDS
  • Pregnant females
  • Participants having significant systemic disorder
  • If analgesics or antibiotics have been taken by the patient during the past 24 hours pre-operatively.
  • Participants with psychological disturbances
  • Participants with bruxism or clenching
  • Participants having acute pain in more than one mandibular molar
  • Participants with mandibular molar teeth showing:

    • Swelling or fistulous tract
    • Acute or chronic periapical abscess
    • Mobility greater than grade I
    • Periodontitis
    • Previous endodontic treatment or non-restorability

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Cryothrapy

    Ketroloc tromethamine

    Saline at room temperature

    Arm Description

    5 ml Saline at low temperature (2.5°C) will be used as intra-canal irrigantion during single visit endodontics treatment, to study the effect on reduction of post-operative pain and expression of IL-8.

    2ml 30 mg Ketroloc tromethamine will be used as intra-canal irrigantion during single visit endodontics treatment, to study the effect on reduction of post-operative pain and expression of IL-8.

    30 ml Saline at room temperature will be used as intra-canal irrigantion during single visit endodontics treatment, to study the effect on reduction of post-operative pain and expression of IL-8.

    Outcomes

    Primary Outcome Measures

    Intensity of post-operative pain
    using the visual analogue scale

    Secondary Outcome Measures

    IL-8 level
    using the ELISA
    Analgesic intake
    counting the number of analgesic tablets taken after endodontic treatment

    Full Information

    First Posted
    January 24, 2021
    Last Updated
    January 27, 2021
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04733326
    Brief Title
    Evaluation of Post-operative Pain and Expression of IL-8 Using Ketolac or Cryoirrigation as a Final Flush in Single Visit Endodontic Treatment in Teeth With Symptomatic Irreversible Pulpitis and Apical Periodontitis.Randomized Clinical Trial.
    Official Title
    Evaluation of Post-operative Pain and Expression of IL-8 Using Ketolac or Cryo-irrigation as a Final Flush in Single Visit Endodontic Treatment in Teeth With Symptomatic Irreversible Pulpitis and Apical Periodontitis.Randomized Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2021 (Anticipated)
    Primary Completion Date
    November 1, 2021 (Anticipated)
    Study Completion Date
    December 1, 2021 (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
    To compare the effect of cryotherapy versus ketorolac tromethamine irrigating solutions used as a final flush in single visit endodontic treatment in mandibular molars, with symptomatic irreversible pulpitis and apical periodontitis on the: Intensity of post-operative pain in patients with symptomatic irreversible pulpitis Reduction of expression of Interleukin-8 (IL-8) post-instrumentation using ELISA The analgesic intake following endodontic treatment for post-operative pain relief.
    Detailed Description
    The main rationale of endodontic treatment is to eliminate micro-organisms from the infected root canal system by adequate chemo-mechanical debridement followed by a three-dimensional hermetic seal to provide a conductive environment for peri-radicular healing. However, Even with the utmost care in performing root canal therapy, it has been reported that the prevalence of post-operative pain after single visit endodontic treatment has been reported to be between 3 to 58%. Non-steroidal anti-inflammatory drugs (NSAIDs) and Steroids have been advocated for control of post-operative pain following root canal treatment in teeth with symptomatic irreversible pulpitis. Ketorolac tromethamine, a potent NSAID that is over 400 times a selective inhibitor for COX-1 over COX-2 as compared to other drugs. In a recent study by (Evangelin et al 2019), assessing the influence of ketorolac tromethamine and dexamethasone when used as root canal irrigant on the expression of substance P and IL-8; showed that dexamethasone irrigation achieved the least post-operative pain and the least requirements for analgesics, whilst ketorolac tromethamine had better control on the expression of substance P and IL-8 as compared to dexamethasone. Additionally, a more recent strategy for reduction of post-operative pain is cryotherapy. Such treatment modality is aimed to expose the body to very cold temperature, resulting in vasoconstriction and decreased permeability thus reducing the amount of fluid leaking into the peri-radicular tissues as exudate which commonly occur after chemo-mechanical preparation. Analgesia is closely related to the nerve conduction velocity of the nociceptive sensory nerve fibers. Thus, cooling induces analgesia by slowing the velocity of nerve conduction as well as decreasing the activation threshold of tissue nociceptors resulting in cold-induced neuropraxia. Thus the analgesic effect of cooling is produced by combination of decreased release of chemical mediators of pain and a slower propagation of neural pain signals. In our study, ketorolac tromethamine, dexamethasone and cryotherapy are supposed to be used as root canal irrigants during root canal treatment to assess their effectiveness in reducing post-operative pain following single visit endodontic treatment in patients with symptomatic irreversible pulpitis, as well as their efficacy in reducing the expression of IL-8. Randomized clinical trials are the gold standard of interventional trials resulting in the highest level of evidence that contributes effectively in the clinical decision-making process as to the best intervention for the patient's condition providing the most effective clinical outcomes for the satisfaction of the patient. Thus the aim of the study is to compare the effect of using cryotherapy versus ketorolac tromethamine and dexamethasone irrigating solutions on the intensity of post-operative pain and reduction of expression of Interleukin-8(IL-8) post-instrumentation in patients with symptomatic irreversible pulpitis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-operative Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    39 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cryothrapy
    Arm Type
    Experimental
    Arm Description
    5 ml Saline at low temperature (2.5°C) will be used as intra-canal irrigantion during single visit endodontics treatment, to study the effect on reduction of post-operative pain and expression of IL-8.
    Arm Title
    Ketroloc tromethamine
    Arm Type
    Experimental
    Arm Description
    2ml 30 mg Ketroloc tromethamine will be used as intra-canal irrigantion during single visit endodontics treatment, to study the effect on reduction of post-operative pain and expression of IL-8.
    Arm Title
    Saline at room temperature
    Arm Type
    Placebo Comparator
    Arm Description
    30 ml Saline at room temperature will be used as intra-canal irrigantion during single visit endodontics treatment, to study the effect on reduction of post-operative pain and expression of IL-8.
    Intervention Type
    Drug
    Intervention Name(s)
    Ketorolac Tromethamine
    Other Intervention Name(s)
    Cryotherapy
    Intervention Description
    final rinse with non-steriodal anti-inflammatory drug or cold saline during single visit endodontic treatment
    Primary Outcome Measure Information:
    Title
    Intensity of post-operative pain
    Description
    using the visual analogue scale
    Time Frame
    24 hours following endoodnitc treatment
    Secondary Outcome Measure Information:
    Title
    IL-8 level
    Description
    using the ELISA
    Time Frame
    during root canal treatment
    Title
    Analgesic intake
    Description
    counting the number of analgesic tablets taken after endodontic treatment
    Time Frame
    first 24 hours after completion of endodontic treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: - Medically free patients Age between 18-40 years old Males or females Participants able to understand Visual Analogue Scale (the pain chart diary) and sign the informed consent ( Appendix I,II). Mandibular permanent molar teeth: Diagnosed clinically with symptomatic irreversible pulpitis associated with apical periodontitis. Presence of spontaneous pain and sharp pain to cold tester (ethyl-chloride) that lingers after removal of the stimulus compared to the contra-lateral tooth Tenderness to percussion with normal periapical radiographic appearance or slight widening of the lamina dura Exclusion Criteria: - Participants allergic to NSAIDS Pregnant females Participants having significant systemic disorder If analgesics or antibiotics have been taken by the patient during the past 24 hours pre-operatively. Participants with psychological disturbances Participants with bruxism or clenching Participants having acute pain in more than one mandibular molar Participants with mandibular molar teeth showing: Swelling or fistulous tract Acute or chronic periapical abscess Mobility greater than grade I Periodontitis Previous endodontic treatment or non-restorability

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Evaluation of Post-operative Pain and Expression of IL-8 Using Ketolac or Cryoirrigation as a Final Flush in Single Visit Endodontic Treatment in Teeth With Symptomatic Irreversible Pulpitis and Apical Periodontitis.Randomized Clinical Trial.

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