Ketorolac Irrigant on Post Operative Pain
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|ClinicalTrials.gov Identifier: NCT04319549|
Recruitment Status : Unknown
Verified March 2020 by Nasrin Salem Bazina, Cairo University.
Recruitment status was: Not yet recruiting
First Posted : March 24, 2020
Last Update Posted : April 21, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Acute Irreversible Pulpitis With Apical Periodontitis||Other: Ketorolac Tromethamine irrigant Other: sodium hypochlorite irrigant||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Post Operative Pain and Expression of Substance P, IL8 After the Use of Ketorolac Irrigant Following Single Visit Root Canal Treatment|
|Estimated Study Start Date :||August 1, 2020|
|Estimated Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||September 1, 2021|
Experimental: group 1 ketorolac tromethamine irrigant
group 1 patients with acute irreversible pulpitis with apical periodontitis
Other: Ketorolac Tromethamine irrigant
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
Other: sodium hypochlorite irrigant
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.
- post operative pain [ Time Frame: intensity of pain by categorical scale from 1-4 ]post operative pain will be measured by categorical scale
- substance P,IL8 Level [ Time Frame: baseline ]inflammatory mediator will be measured by ELISA
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|Ages Eligible for Study:||16 Years to 60 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
|Responsible Party:||Nasrin Salem Bazina, principal invistigator, Cairo University|
|Other Study ID Numbers:||
|First Posted:||March 24, 2020 Key Record Dates|
|Last Update Posted:||April 21, 2020|
|Last Verified:||March 2020|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Dental Pulp Diseases
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action