- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04319549
Ketorolac Irrigant on Post Operative Pain
Post Operative Pain and Expression of Substance P, IL8 After the Use of Ketorolac Irrigant Following Single Visit Root Canal Treatment
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: group 1 ketorolac tromethamine irrigant
group 1 patients with acute irreversible pulpitis with apical periodontitis
|
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.
|
Active Comparator: group 2 sodium hypochlorite irrigant
group 2 patients with acute irreversible pulpitis with apical periodontitis
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
post operative pain
Time Frame: intensity of pain by categorical scale from 1-4
|
post operative pain will be measured by categorical scale
|
intensity of pain by categorical scale from 1-4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
substance P,IL8 Level
Time Frame: baseline
|
inflammatory mediator will be measured by ELISA
|
baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Stomatognathic Diseases
- Periodontal Diseases
- Mouth Diseases
- Tooth Diseases
- Jaw Diseases
- Dental Pulp Diseases
- Periapical Diseases
- Pain, Postoperative
- Periodontitis
- Pulpitis
- Periapical Periodontitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Disinfectants
- Ketorolac
- Ketorolac Tromethamine
- Sodium Hypochlorite
- Eusol
Other Study ID Numbers
- ketorolac irrigant
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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