search
Back to results

Ketorolac Irrigant on Post Operative Pain

Primary Purpose

Acute Irreversible Pulpitis With Apical Periodontitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ketorolac Tromethamine irrigant
sodium hypochlorite irrigant
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Irreversible Pulpitis With Apical Periodontitis

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age between 15-60 years old.
  2. Systemically healthy patient (ASA I or II).
  3. Male & female.
  4. Molar or premolar teeth with:
  5. Preoperative moderate to severe pain.
  6. with or without slight widening in the periodontal membrane space
  7. Patients' acceptance to participate in the trial.

Exclusion Criteria:

  1. Patients allergic to anesthetics.
  2. Patients having significant systemic disorder (ASA III or IV).
  3. Hemostatic disorders or anti-coagulant therapy during the last month.
  4. Retreatment cases
  5. Pregnant women: Avoid radiation exposure, anesthesia, and medication.
  6. No restorability: Hopeless tooth.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    group 1 ketorolac tromethamine irrigant

    group 2 sodium hypochlorite irrigant

    Arm Description

    group 1 patients with acute irreversible pulpitis with apical periodontitis

    group 2 patients with acute irreversible pulpitis with apical periodontitis

    Outcomes

    Primary Outcome Measures

    post operative pain
    post operative pain will be measured by categorical scale

    Secondary Outcome Measures

    substance P,IL8 Level
    inflammatory mediator will be measured by ELISA

    Full Information

    First Posted
    March 20, 2020
    Last Updated
    April 18, 2020
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04319549
    Brief Title
    Ketorolac Irrigant on Post Operative Pain
    Official Title
    Post Operative Pain and Expression of Substance P, IL8 After the Use of Ketorolac Irrigant Following Single Visit Root Canal Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2020 (Anticipated)
    Primary Completion Date
    July 1, 2021 (Anticipated)
    Study Completion Date
    September 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
    Endodontic post-treatment pain management is one of the most challenging problems in the clinical practice of endodontics. Although this pain is decreased after root canal treatment, there may be residual symptoms due to inflammation. It has been reported that up to 80% of patients with preoperative pain, will report pain after endodontic treatment, which might range from mild to severe. Management of endodontic pain should involve all steps of treatment including preoperative pain control through accurate diagnosis and reduction of anxiety, intraoperative pain control through effective and profound local anesthetic, operative techniques and that can be achieved through a variety of pharmacologic agents. Many mechanisms have been proposed to explain the reason for postoperative pain including the sensitization of nociceptors by inflammatory mediators. Among these chemical inflammatory mediators are the prostaglandins which is the terminal product of arachidonic acid metabolism, through the cyclooxygenase (COX) pathway. Endodontic treatment can cause the release of inflammatory mediators (e.g. prostaglandins, leukotrienes, bradykinin, platelet- activating factor and substance P) into the surrounding periapical tissues, causing pain fibers to be directly stimulated (by bradykinin for instance) or sensitized (by prostaglandins). In addition, the vascular dilation and increased permeability as a consequence of periradicular inflammation, cause edema and increased interstitial tissue response. Single-visit root canal treatment is common in some endodontic practices. However, one of the main concerns with this approach has been the fear of post- operative pain. Mechanical, chemical and microbiological injuries to the peri- radicular tissues during root canal treatment have been suggested as possible causes of post-operative pain. The role of irrigating solutions used during root canal treatment to help control post-operative pain is unclear. While certain studies have observed a reduction in post-operative pain with particular types and concentrations of irrigating solutions, other studies have reported no difference in post-operative pain with the different irrigating solutions .
    Detailed Description
    When the treatment itself appears to initiate the onset of pain and/or swelling, the result can be very distressing to both the patient and the operator. Patients might even consider postoperative pain and flare-up as a benchmark against which the clinician's skills are measured. Prevalence of postoperative pain or flare-up is, therefore, one of the influencing factors when making a clinical decision. Better management of postoperative pain increases the patients' confidence in dentist's skills and gives positive attitude toward dental profession. The major cause of this pain is thought to be because of the release of inflammatory mediators that stimulate sensitive nociceptors surrounding the tooth. The resultant stimulation of both central and peripheral mechanisms is described as hyperalgesia which is defined as an increase in the perceived degree of a painful stimulus. One of the many inflammatory mediators, IL-8 has been extensively considered as a potential marker for irreversible pulpitis. Increased expression of IL-8 is correlated with increased polymorphonuclear neutrophils (PMNs) within the pulp because IL-8 induces neutrophil chemotaxis and release of degradation enzymes during degranulation. Substance P was the initial neuropeptide identified in the dental tissues. The released substance P further promotes the release of short-lived inflammatory mediators providing a fresh supply of prostaglandins (iPGE2), leukotriene (iLTB4) and bradykinins. These sustained effects of the released inflammatory mediators are part of a local positive feedback cycle. Neuronal responses in the dental pulp due to caries have been shown to alter the anatomical distribution of nerve fibers, leading to increases in neuropeptide expression and increased pain sensitivity as a result of peripheral sensitization. Prostaglandin construction in this inflammatory process is via the cyclooxygenase pathway. Ketorolac tromethamine, a potent NSAID available in both oral and injectable forms, is over 400 times more potent as a selective inhibitor of COX-1 over COX-2 than many other drugs. When ketorolac tromethamine was used as an intracanal medicament in teeth with irreversible pulpitis undergoing root canal treatment, it contributed to significant post operative pain relief.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Irreversible Pulpitis With Apical Periodontitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    44 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group 1 ketorolac tromethamine irrigant
    Arm Type
    Experimental
    Arm Description
    group 1 patients with acute irreversible pulpitis with apical periodontitis
    Arm Title
    group 2 sodium hypochlorite irrigant
    Arm Type
    Active Comparator
    Arm Description
    group 2 patients with acute irreversible pulpitis with apical periodontitis
    Intervention Type
    Other
    Intervention Name(s)
    Ketorolac Tromethamine irrigant
    Intervention Description
    Ketorolac tromethamine, a potent NSAID available in both oral and injectable forms, is over 400 times more potent as a selective inhibitor of COX-1 over COX-2 than many other drugs. When ketorolac tromethamine was used as an intracanal medicament in teeth with irreversible pulpitis undergoing root canal treatment, it contributed to significant post operative pain relief.
    Intervention Type
    Other
    Intervention Name(s)
    sodium hypochlorite irrigant
    Intervention Description
    NaOCl is the gold standard and the most commonly used root canal irrigant. NaOCl is able to dissolve the organic tissues inside root canal due to its alkalinity (pH11), which causes amino acid degradation and hydrolysis through the production of chloramine molecules. In addition, it possesses highly antibacterial effect and its low cost makes it the most frequently used root canal irrigant. Dual rinse is considered an effective time saving root canal irrigant with a better antibacterial property in comparison to NaOCl alone. In addition to its effectiveness on smear layer removal and reduction in the debris accumulation during root canal instrumentation.
    Primary Outcome Measure Information:
    Title
    post operative pain
    Description
    post operative pain will be measured by categorical scale
    Time Frame
    intensity of pain by categorical scale from 1-4
    Secondary Outcome Measure Information:
    Title
    substance P,IL8 Level
    Description
    inflammatory mediator will be measured by ELISA
    Time Frame
    baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age between 15-60 years old. Systemically healthy patient (ASA I or II). Male & female. Molar or premolar teeth with: Preoperative moderate to severe pain. with or without slight widening in the periodontal membrane space Patients' acceptance to participate in the trial. Exclusion Criteria: Patients allergic to anesthetics. Patients having significant systemic disorder (ASA III or IV). Hemostatic disorders or anti-coagulant therapy during the last month. Retreatment cases Pregnant women: Avoid radiation exposure, anesthesia, and medication. No restorability: Hopeless tooth.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31270901
    Citation
    Bamini L, Anand Sherwood I, Abbott PV, Uthandakalaipandian R, Velu V. Influence of anti-inflammatory irrigant on substance P expression for single-visit root canal treatment of teeth with irreversible pulpitis. Aust Endod J. 2020 Apr;46(1):73-81. doi: 10.1111/aej.12353. Epub 2019 Jul 3.
    Results Reference
    background
    PubMed Identifier
    31270902
    Citation
    Evangelin J, Sherwood IA, Abbott PV, Uthandakalaipandian R, Velu V. Influence of different irrigants on substance P and IL-8 expression for single visit root canal treatment in acute irreversible pulpitis. Aust Endod J. 2020 Apr;46(1):17-25. doi: 10.1111/aej.12340. Epub 2019 Jul 3.
    Results Reference
    background

    Learn more about this trial

    Ketorolac Irrigant on Post Operative Pain

    We'll reach out to this number within 24 hrs