Postoperative PainPhase 2NCT06584188
The Effect of Anti-inflammatory Cryoagent on the Level of Postoperative Pain in Patients With Symptomatic Irreversible Pulpitis and Apical Periodontitis.
A Phase 2 study testing anti-inflammatory ketorolac tromethamine in people with Postoperative Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is comparative between: 1. Intra-radicular cryotherapy using cold anti-inflammatory {ketorolac tromethamine at 2-5C}. 2. Intra-radicular final flush anti-inflammatory {ketorolac tromethamine at room temperature}. In terms of: C. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- anti-inflammatory ketorolac tromethamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Apr 2026to 30 Apr 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Patients that will be diagnosed with symptomatic irreversible pulpitis and apical periodontitis.
- Patient age ranging from 18-40 years.
- Males or females.
- Lower premolars.
- Medically free patients.
- Teeth with mature apex.
- Teeth without any type of root resorption.
Who cannot join
- Patients with other pulpal diagnosis.
- Medically compromised patients.
- Vulnerable group; pregnant females, mentally ill, etc...
- Patients taking analgesics or anti-inflammatory drugs.
- Teeth with open apex.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
- The aim of this study is comparative between:
- Intra-radicular cryotherapy using cold anti-inflammatory {ketorolac tromethamine at 2-5C}.
- Intra-radicular final flush anti-inflammatory {ketorolac tromethamine at room temperature}.
- In terms of:
- Level of post-operative pain {POP} using a visual analog scale {VAS}. D. Level of substance P in periapical fluid will be analyzed by enzyme-linked immunosorbent assay (ELISA) kit.
Outcomes :
- Primary outcomes: Level of Post-operative pain.
- Secondary outcomes: Level of substance P expression
- Conditions
- Postoperative Pain
- Being tested
- anti-inflammatory ketorolac tromethamine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-inflammatory ketorolac tromethamineDrug
- Intra- radicular anti-inflammatory {ketorolac tromethamine at room temperature}.
- Intra- radicular cold anti-inflammatory {ketorolac tromethamine at 2-5C}.
| Study group | Role | What they receive |
|---|---|---|
| Intra-radicular saline at room temperature | Experimental | * Final flush with 20 mL of saline solution
* At room temperature for 5 minutes.
* Three samples will be collected from periapical fluid . Receives: Drug: anti-inflammatory ketorolac tromethamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of pre-operative pain.
measure intensity of post operative pain using visual analogue scale that was represented by a 100 mm horizontal ruler with no number markings other than a 0 at one end and a 10 at the other end. The following categories of postoperative pain levels were used to assess pain: 0 indicating no pain, mild pain (1-3), moderate pain (4-7) and severe pain (8-10)
Measured: before start the operative
Level of Post-operative pain.
measure intensity of post operative pain using visual analogue scale that was represented by a 100 mm horizontal ruler with no number markings other than a 0 at one end and a 10 at the other end. The following categories of postoperative pain levels were used to assess pain: 0 indicating no pain, mild pain (1-3), moderate pain (4-7) and severe pain (8-10)
Measured: 6 hours post operative
Level of Post-operative pain.
measure intensity of post operative pain using visual analogue scale that was represented by a 100 mm horizontal ruler with no number markings other than a 0 at one end and a 10 at the other end. The following categories of postoperative pain levels were used to assess pain: 0 indicating no pain, mild pain (1-3), moderate pain (4-7) and severe pain (8-10)
Measured: 24 hours post operative
Level of Post-operative pain.
measure intensity of post operative pain using visual analogue scale that was represented by a 100 mm horizontal ruler with no number markings other than a 0 at one end and a 10 at the other end. The following categories of postoperative pain levels were used to assess pain: 0 indicating no pain, mild pain (1-3), moderate pain (4-7) and severe pain (8-10)
Measured: 48 hours post operative
Level of Post-operative pain.
measure intensity of post operative pain using visual analogue scale that was represented by a 100 mm horizontal ruler with no number markings other than a 0 at one end and a 10 at the other end. The following categories of postoperative pain levels were used to assess pain: 0 indicating no pain, mild pain (1-3), moderate pain (4-7) and severe pain (8-10)
Measured: 72 hours post operative
Secondary outcomes (3)
Level of substance P expression.
Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab.
Measured: 15 minutes following access cavity preparation.
Level of substance P expression.
Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab.
Measured: 30 minutes following access cavity preparation.
Level of substance P expression.
Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab.
Measured: Immediately prior to obturation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start11 Apr 2026 (estimated)
- Primary completion12 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, abdulrahman ziad elwadiah, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584188
- Sponsor's protocol ID
- DentAinShams
- Status last verified
- Apr 2026
- First submitted
- 11 Feb 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Anti-inflammatory Cryoagent on the Level of Postoperative Pain in Patients With Symptomatic Irreversible Pulpitis and Apical Periodontitis.
- ClinicalTrials.gov ID
- NCT06584188
- Acronym / sponsor ID
- DentAinShams
- Conditions
- Postoperative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 11 Apr 2026 (estimated)
- Primary completion
- 12 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 4 Sep 2024 (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.
- The aim of this study is comparative between:
- Intra-radicular cryotherapy using cold anti-inflammatory {ketorolac tromethamine at 2-5C}.
- Intra-radicular final flush anti-inflammatory {ketorolac tromethamine at room temperature}.
- In terms of:
- Level of post-operative pain {POP} using a visual analog scale {VAS}. D. Level of substance P in periapical fluid will be analyzed by enzyme-linked immunosorbent assay (ELISA) kit.
Outcomes :
- Primary outcomes: Level of Post-operative pain.
- Secondary outcomes: Level of substance P expression
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra-radicular saline at room temperature | Experimental | Drug: anti-inflammatory ketorolac tromethamine* Final flush with 20 mL of saline solution * At room temperature for 5 minutes. * Three samples will be collected from periapical fluid . |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients that will be diagnosed with symptomatic irreversible pulpitis and apical periodontitis.
- Patient age ranging from 18-40 years.
- Males or females.
- Lower premolars.
- Medically free patients.
Key exclusion criteria (5 listed)
- Patients with other pulpal diagnosis.
- Medically compromised patients.
- Vulnerable group; pregnant females, mentally ill, etc...
- Patients taking analgesics or anti-inflammatory drugs.
- Teeth with open apex.
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 |
|---|---|---|
| anti-inflammatory ketorolac tromethamine* Intra- radicular anti-inflammatory {ketorolac tromethamine at room temperature}. * Intra- radicular cold anti-inflammatory {ketorolac tromethamine at 2-5C}. | Drug | Intra-radicular saline at room temperature |
Primary outcome
Level of pre-operative pain.
Time frame: before start the operative
measure intensity of post operative pain using visual analogue scale that was represented by a 100 mm horizontal ruler with no number markings other than a 0 at one end and a 10 at the other end. The following categories of postoperative pain levels were used to assess pain: 0 indicating no pain, mild pain (1-3), moderate pain (4-7) and severe pain (8-10)
Level of Post-operative pain.
Time frame: 6 hours post operative
measure intensity of post operative pain using visual analogue scale that was represented by a 100 mm horizontal ruler with no number markings other than a 0 at one end and a 10 at the other end. The following categories of postoperative pain levels were used to assess pain: 0 indicating no pain, mild pain (1-3), moderate pain (4-7) and severe pain (8-10)
Level of Post-operative pain.
Time frame: 24 hours post operative
measure intensity of post operative pain using visual analogue scale that was represented by a 100 mm horizontal ruler with no number markings other than a 0 at one end and a 10 at the other end. The following categories of postoperative pain levels were used to assess pain: 0 indicating no pain, mild pain (1-3), moderate pain (4-7) and severe pain (8-10)
Level of Post-operative pain.
Time frame: 48 hours post operative
measure intensity of post operative pain using visual analogue scale that was represented by a 100 mm horizontal ruler with no number markings other than a 0 at one end and a 10 at the other end. The following categories of postoperative pain levels were used to assess pain: 0 indicating no pain, mild pain (1-3), moderate pain (4-7) and severe pain (8-10)
Level of Post-operative pain.
Time frame: 72 hours post operative
measure intensity of post operative pain using visual analogue scale that was represented by a 100 mm horizontal ruler with no number markings other than a 0 at one end and a 10 at the other end. The following categories of postoperative pain levels were used to assess pain: 0 indicating no pain, mild pain (1-3), moderate pain (4-7) and severe pain (8-10)
3 secondary outcomes
Level of substance P expression.
Time frame: 15 minutes following access cavity preparation.
Level of substance P expression.
Time frame: 30 minutes following access cavity preparation.
Level of substance P expression.
Time frame: Immediately prior to obturation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 2 study testing anti-inflammatory ketorolac tromethamine in people with Postoperative Pain, run by Ain Shams 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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 15 Apr 2026. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Level of pre-operative pain. (time frame: before start the operative). The study lists 5 primary outcomes in all. 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 15 Apr 2026.