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

NCT06584188 | Not Yet Recruiting Phase 2

• 1 other identifier: DentAinShams
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

• 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

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (5)

• 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)

  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)

  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)

  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)

  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)

  72 hours post operative

Secondary Outcomes (3)

• Level of substance P expression.

  15 minutes following access cavity preparation.

• Level of substance P expression.

  30 minutes following access cavity preparation.

• Level of substance P expression.

  Immediately prior to obturation

Study Arms (1)

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 .

Drug: anti-inflammatory ketorolac tromethamine

Interventions

anti-inflammatory ketorolac tromethamine DRUG

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

Intra-radicular saline at room temperature

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry, Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: abdelrahman ziad kasem@dent.asu.edu.eg

Study Record Dates

• First Submitted: February 11, 2024
• First Posted: September 4, 2024
• Study Start: April 11, 2026
• Primary Completion: April 12, 2026
• Study Completion: April 30, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

EG (1)