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NCT Number: NCT06584188

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

* 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

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Dentistry, Ain Shams University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

anti-inflammatory ketorolac tromethamine

Drug
  • Intra- radicular anti-inflammatory {ketorolac tromethamine at room temperature}.
  • Intra- radicular cold anti-inflammatory {ketorolac tromethamine at 2-5C}.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2024
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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