Post-operative PainPhase 1NCT04733326
Evaluation of Post-operative Pain and Expression of IL-8 Using Ketolac or Cryoirrigation as a Final Flush in Single Visit Endodontic Treatment in Teeth With Symptomatic Irreversible Pulpitis and Apical Periodontitis.Randomized Clinical Trial.
A Phase 1 study testing Ketorolac Tromethamine, Cryotherapy and Saline in people with Post-operative Pain, run by Cairo University at 1 site in Egypt.
Trial summary
To compare the effect of cryotherapy versus ketorolac tromethamine irrigating solutions used as a final flush in single visit endodontic treatment in mandibular molars, with symptomatic irreversible pulpitis and apical periodontitis on the: Intensity of post-operative pain in patients with symptomatic irreversible… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Ketorolac Tromethamine, Cryotherapy and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 1 Mar 2023
- Phase
- Phase 1
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- - Medically free patients
- Age between 18-40 years old
- Males or females
- Participants able to understand Visual Analogue Scale (the pain chart diary) and sign the informed consent ( Appendix I,II).
- Mandibular permanent molar teeth:
- Diagnosed clinically with symptomatic irreversible pulpitis associated with apical periodontitis.
- Presence of spontaneous pain and sharp pain to cold tester (ethyl-chloride) that lingers after removal of the stimulus compared to the contra-lateral tooth
- Tenderness to percussion with normal periapical radiographic appearance or slight widening of the lamina dura
Who cannot join
- - Participants allergic to NSAIDS
- Pregnant females
- Participants having significant systemic disorder
- If analgesics or antibiotics have been taken by the patient during the past 24 hours pre-operatively.
- Participants with psychological disturbances
- Participants with bruxism or clenching
Show all 13Show fewer
- Participants having acute pain in more than one mandibular molar
- Participants with mandibular molar teeth showing:
- Swelling or fistulous tract
- Acute or chronic periapical abscess
- Mobility greater than grade I
- Periodontitis
- Previous endodontic treatment or non-restorability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Post-operative Pain and Expression of IL-8 Using Different Irrigate as Compared to Cryotherapy for Single Visit Endodontic Treatment in Teeth With Symptomatic Irreversible Pulpitis and Apical Periodontitis.Randomized Clinical Trial.
To compare the effect of cryotherapy versus ketorolac tromethamine irrigating solutions used as a final flush in single visit endodontic treatment in mandibular molars, with symptomatic irreversible pulpitis and apical periodontitis on the:
- Intensity of post-operative pain in patients with symptomatic irreversible pulpitis
- Reduction of expression of Interleukin-8 (IL-8) post-instrumentation using ELISA
- The analgesic intake following endodontic treatment for post-operative pain relief.
Read the detailed description
The main rationale of endodontic treatment is to eliminate micro-organisms from the infected root canal system by adequate chemo-mechanical debridement followed by a three-dimensional hermetic seal to provide a conductive environment for peri-radicular healing. However, Even with the utmost care in performing root canal therapy, it has been reported that the prevalence of post-operative pain after single visit endodontic treatment has been reported to be between 3 to 58%.
Non-steroidal anti-inflammatory drugs (NSAIDs) and Steroids have been advocated for control of post-operative pain following root canal treatment in teeth with symptomatic irreversible pulpitis. Ketorolac tromethamine, a potent NSAID that is over 400 times a selective inhibitor for COX-1 over COX-2 as compared to other drugs. In a recent study by (Evangelin et al 2019), assessing the influence of ketorolac tromethamine and dexamethasone when used as root canal irrigant on the expression of substance P and IL-8; showed that dexamethasone irrigation achieved the least post-operative pain and the least requirements for analgesics, whilst ketorolac tromethamine had better control on the expression of substance P and IL-8 as compared to dexamethasone.
Additionally, a more recent strategy for reduction of post-operative pain is cryotherapy. Such treatment modality is aimed to expose the body to very cold temperature, resulting in vasoconstriction and decreased permeability thus reducing the amount of fluid leaking into the peri-radicular tissues as exudate which commonly occur after chemo-mechanical preparation. Analgesia is closely related to the nerve conduction velocity of the nociceptive sensory nerve fibers. Thus, cooling induces analgesia by slowing the velocity of nerve conduction as well as decreasing the activation threshold of tissue nociceptors resulting in cold-induced neuropraxia. Thus the analgesic effect of cooling is produced by combination of decreased release of chemical mediators of pain and a slower propagation of neural pain signals.
In our study, ketorolac tromethamine, dexamethasone and cryotherapy are supposed to be used as root canal irrigants during root canal treatment to assess their effectiveness in reducing post-operative pain following single visit endodontic treatment in patients with symptomatic irreversible pulpitis, as well as their efficacy in reducing the expression of IL-8. Randomized clinical trials are the gold standard of interventional trials resulting in the highest level of evidence that contributes effectively in the clinical decision-making process as to the best intervention for the patient's condition providing the most effective clinical outcomes for the satisfaction of the patient. Thus the aim of the study is to compare the effect of using cryotherapy versus ketorolac tromethamine and dexamethasone irrigating solutions on the intensity of post-operative pain and reduction of expression of Interleukin-8(IL-8) post-instrumentation in patients with symptomatic irreversible pulpitis.
- Conditions
- Post-operative Pain
- Being tested
- Ketorolac Tromethamine, Cryotherapy, Saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac TromethamineDrug
Also called Ketolac
final rinse with non-steriodal anti-inflammatory drug during single visit endodontic treatment in mandibular molar teeth with symptomatic irreversible pulpits and apical periodontitis
CryotherapyOther
Also called Cold saline
final rinse with cold saline during single visit endodontic treatment in mandibular molar teeth with symptomatic irreversible pulpits and apical periodontitis
SalineOther
final rinse with saline at room temperature during single visit endodontic treatment in mandibular molar teeth with symptomatic irreversible pulpits and apical periodontitis
| Study group | Role | What they receive |
|---|---|---|
| Cryothrapy | Experimental | 5 ml Saline at low temperature (2.5°C) will be used as intra-canal irrigantion during single visit endodontics treatment, to study the effect on reduction of post-operative pain and expression of IL-8. Receives: Other: Cryotherapy |
| Ketroloc tromethamine | Experimental | 2ml 30 mg Ketroloc tromethamine will be used as intra-canal irrigantion during single visit endodontics treatment, to study the effect on reduction of post-operative pain and expression of IL-8. Receives: Drug: Ketorolac Tromethamine |
| Saline at room temperature | Placebo comparator | 30 ml Saline at room temperature will be used as intra-canal irrigantion during single visit endodontics treatment, to study the effect on reduction of post-operative pain and expression of IL-8. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of post-operative pain
using the visual analogue scale
Measured: 24 hours following endoodnitc treatment
Secondary outcomes (2)
IL-8 level
using the ELISA
Measured: during root canal treatment
Analgesic intake
counting the number of analgesic tablets taken after endodontic treatment
Measured: first 24 hours after completion of endodontic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start1 Sep 2021
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants presenting with symptomatic irreversible pulpits and apical periodontitis in their mandibular molars
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yousra Khaled Mohamed Ezzat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733326
- Sponsor's protocol ID
- CairoU0
- Status last verified
- Sep 2024
- First submitted
- 24 Jan 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-operative Pain and Expression of IL-8 Using Different Irrigate as Compared to Cryotherapy for Single Visit Endodontic Treatment in Teeth With Symptomatic Irreversible Pulpitis and Apical Periodontitis.Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04733326
- Acronym / sponsor ID
- CairoU0
- Conditions
- Post-operative Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 2 Feb 2021 (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.
To compare the effect of cryotherapy versus ketorolac tromethamine irrigating solutions used as a final flush in single visit endodontic treatment in mandibular molars, with symptomatic irreversible pulpitis and apical periodontitis on the:
- Intensity of post-operative pain in patients with symptomatic irreversible pulpitis
- Reduction of expression of Interleukin-8 (IL-8) post-instrumentation using ELISA
- The analgesic intake following endodontic treatment for post-operative pain relief.
Detailed description
The main rationale of endodontic treatment is to eliminate micro-organisms from the infected root canal system by adequate chemo-mechanical debridement followed by a three-dimensional hermetic seal to provide a conductive environment for peri-radicular healing. However, Even with the utmost care in performing root canal therapy, it has been reported that the prevalence of post-operative pain after single visit endodontic treatment has been reported to be between 3 to 58%.
Non-steroidal anti-inflammatory drugs (NSAIDs) and Steroids have been advocated for control of post-operative pain following root canal treatment in teeth with symptomatic irreversible pulpitis. Ketorolac tromethamine, a potent NSAID that is over 400 times a selective inhibitor for COX-1 over COX-2 as compared to other drugs. In a recent study by (Evangelin et al 2019), assessing the influence of ketorolac tromethamine and dexamethasone when used as root canal irrigant on the expression of substance P and IL-8; showed that dexamethasone irrigation achieved the least post-operative pain and the least requirements for analgesics, whilst ketorolac tromethamine had better control on the expression of substance P and IL-8 as compared to dexamethasone.
Additionally, a more recent strategy for reduction of post-operative pain is cryotherapy. Such treatment modality is aimed to expose the body to very cold temperature, resulting in vasoconstriction and decreased permeability thus reducing the amount of fluid leaking into the peri-radicular tissues as exudate which commonly occur after chemo-mechanical preparation. Analgesia is closely related to the nerve conduction velocity of the nociceptive sensory nerve fibers. Thus, cooling induces analgesia by slowing the velocity of nerve conduction as well as decreasing the activation threshold of tissue nociceptors resulting in cold-induced neuropraxia. Thus the analgesic effect of cooling is produced by combination of decreased release of chemical mediators of pain and a slower propagation of neural pain signals.
In our study, ketorolac tromethamine, dexamethasone and cryotherapy are supposed to be used as root canal irrigants during root canal treatment to assess their effectiveness in reducing post-operative pain following single visit endodontic treatment in patients with symptomatic irreversible pulpitis, as well as their efficacy in reducing the expression of IL-8. Randomized clinical trials are the gold standard of interventional trials resulting in the highest level of evidence that contributes effectively in the clinical decision-making process as to the best intervention for the patient's condition providing the most effective clinical outcomes for the satisfaction of the patient. Thus the aim of the study is to compare the effect of using cryotherapy versus ketorolac tromethamine and dexamethasone irrigating solutions on the intensity of post-operative pain and reduction of expression of Interleukin-8(IL-8) post-instrumentation in patients with symptomatic irreversible pulpitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants presenting with symptomatic irreversible pulpits and apical periodontitis in their mandibular molars
| Arm | Type | Receives |
|---|---|---|
| Cryothrapy | Experimental | Other: Cryotherapy5 ml Saline at low temperature (2.5°C) will be used as intra-canal irrigantion during single visit endodontics treatment, to study the effect on reduction of post-operative pain and expression of IL-8. |
| Ketroloc tromethamine | Experimental | Drug: Ketorolac Tromethamine2ml 30 mg Ketroloc tromethamine will be used as intra-canal irrigantion during single visit endodontics treatment, to study the effect on reduction of post-operative pain and expression of IL-8. |
| Saline at room temperature | Placebo comparator | Other: Saline30 ml Saline at room temperature will be used as intra-canal irrigantion during single visit endodontics treatment, to study the effect on reduction of post-operative pain and expression of IL-8. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- - Medically free patients
- Age between 18-40 years old
- Males or females
- Participants able to understand Visual Analogue Scale (the pain chart diary) and sign the informed consent ( Appendix I,II).
- Mandibular permanent molar teeth:
Key exclusion criteria (13 listed)
- - Participants allergic to NSAIDS
- Pregnant females
- Participants having significant systemic disorder
- If analgesics or antibiotics have been taken by the patient during the past 24 hours pre-operatively.
- Participants with psychological disturbances
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 TromethamineAlso: Ketolacfinal rinse with non-steriodal anti-inflammatory drug during single visit endodontic treatment in mandibular molar teeth with symptomatic irreversible pulpits and apical periodontitis | Drug | Ketroloc tromethamine |
| CryotherapyAlso: Cold salinefinal rinse with cold saline during single visit endodontic treatment in mandibular molar teeth with symptomatic irreversible pulpits and apical periodontitis | Other | Cryothrapy |
| Salinefinal rinse with saline at room temperature during single visit endodontic treatment in mandibular molar teeth with symptomatic irreversible pulpits and apical periodontitis | Other | Saline at room temperature |
Primary outcome
Intensity of post-operative pain
Time frame: 24 hours following endoodnitc treatment
using the visual analogue scale
2 secondary outcomes
IL-8 level
Time frame: during root canal treatment
Analgesic intake
Time frame: first 24 hours after completion of endodontic treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketorolac Tromethamine, Cryotherapy and Saline in people with Post-operative Pain, run by Cairo University at 1 site in Egypt.
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 8 inclusion and 13 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intensity of post-operative pain (time frame: 24 hours following endoodnitc treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.