Acute Irreversible Pulpitis With Apical PeriodontitisNCT04319549
Ketorolac Irrigant on Post Operative Pain
A study testing Ketorolac Tromethamine irrigant and sodium hypochlorite irrigant in people with Acute Irreversible Pulpitis With Apical Periodontitis, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Irreversible Pulpitis With Apical Periodontitis
- What is being tested?
- Ketorolac Tromethamine irrigant and sodium hypochlorite irrigant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Post Operative Pain and Expression of Substance P, IL8 After the Use of Ketorolac Irrigant Following Single Visit Root Canal Treatment
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 .
Read the 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.
- Being tested
- Ketorolac Tromethamine irrigant, sodium hypochlorite irrigant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac Tromethamine irrigantOther
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.
sodium hypochlorite irrigantOther
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.
| Study group | Role | What they receive |
|---|---|---|
| group 1 ketorolac tromethamine irrigant | Experimental | group 1 patients with acute irreversible pulpitis with apical periodontitis Receives: Other: Ketorolac Tromethamine irrigant |
| group 2 sodium hypochlorite irrigant | Active comparator | group 2 patients with acute irreversible pulpitis with apical periodontitis Receives: Other: sodium hypochlorite irrigant |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain
post operative pain will be measured by categorical scale
Measured: intensity of pain by categorical scale from 1-4
Secondary outcomes (1)
substance P,IL8 Level
inflammatory mediator will be measured by ELISA
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start1 Aug 2020 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Irreversible Pulpitis With Apical PeriodontitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasrin Salem Bazina, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319549
- Sponsor's protocol ID
- ketorolac irrigant
- Status last verified
- Mar 2020
- First submitted
- 20 Mar 2020
- Last updated
- 21 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31270901Evangelin 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.
PubMed 31270902
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Operative Pain and Expression of Substance P, IL8 After the Use of Ketorolac Irrigant Following Single Visit Root Canal Treatment
- ClinicalTrials.gov ID
- NCT04319549
- Acronym / sponsor ID
- ketorolac irrigant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 ketorolac tromethamine irrigant | Experimental | Other: Ketorolac Tromethamine irrigantgroup 1 patients with acute irreversible pulpitis with apical periodontitis |
| group 2 sodium hypochlorite irrigant | Active comparator | Other: sodium hypochlorite irrigantgroup 2 patients with acute irreversible pulpitis with apical periodontitis |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketorolac Tromethamine irrigantKetorolac 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. | Other | group 1 ketorolac tromethamine irrigant |
| sodium hypochlorite irrigantNaOCl 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. | Other | group 2 sodium hypochlorite irrigant |
Primary outcome
post operative pain
Time frame: intensity of pain by categorical scale from 1-4
post operative pain will be measured by categorical scale
1 secondary outcome
substance P,IL8 Level
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Background: PubMed 31270901Bamini 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.
- Background: PubMed 31270902Evangelin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ketorolac Tromethamine irrigant and sodium hypochlorite irrigant in people with Acute Irreversible Pulpitis With Apical Periodontitis, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative pain (time frame: intensity of pain by categorical scale from 1-4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04319549, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.