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
About this trial
This is an interventional treatment trial for Acute Irreversible Pulpitis With Apical Periodontitis
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.
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
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
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Ketorolac Irrigant on Post Operative Pain
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