The Effect of Anti-inflammatory Cryoagent on the Level of Postoperative Pain in Patients With Symptomatic Irreversible Pulpitis and Apical Periodontitis.

April 11, 2026 updated by: abdulrahman ziad elwadiah, Ain Shams University

  • 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. 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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Dentistry, Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Patients that will be diagnosed with symptomatic irreversible pulpitis and apical periodontitis.
  2. Patient age ranging from 18-40 years.
  3. Males or females.
  4. Lower premolars.
  5. Medically free patients.
  6. Teeth with mature apex.
  7. Teeth without any type of root resorption.

Exclusion Criteria:

  1. Patients with other pulpal diagnosis.
  2. Medically compromised patients.
  3. Vulnerable group; pregnant females, mentally ill, etc...
  4. Patients taking analgesics or anti-inflammatory drugs.
  5. Teeth with open apex.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intra-radicular saline at room temperature
  • Final flush with 20 mL of saline solution
  • At room temperature for 5 minutes.
  • Three samples will be collected from periapical fluid .
Drug: anti-inflammatory ketorolac tromethamine
  • Intra- radicular anti-inflammatory {ketorolac tromethamine at room temperature}.
  • Intra- radicular cold anti-inflammatory {ketorolac tromethamine at 2-5C}.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
before start the operative
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)
6 hours post operative
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)
24 hours post operative
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)
48 hours post operative
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)
72 hours post operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of substance P expression.
Time Frame: 15 minutes following access cavity preparation.
Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab.
15 minutes following access cavity preparation.
Level of substance P expression.
Time Frame: 30 minutes following access cavity preparation.
Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab.
30 minutes following access cavity preparation.
Level of substance P expression.
Time Frame: Immediately prior to obturation
Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab.
Immediately prior to obturation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 11, 2026

Primary Completion (Estimated)

April 12, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

February 11, 2024

First Submitted That Met QC Criteria

September 1, 2024

First Posted (Actual)

September 4, 2024

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 11, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DentAinShams

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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