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

NCT ID: NCT06584188

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-09-30

Brief 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. 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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 .

Group Type: EXPERIMENTAL

anti-inflammatory ketorolac tromethamine

Intervention Type: DRUG

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

Interventions

anti-inflammatory ketorolac tromethamine

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

abdulrahman ziad elwadiah

abdelrahman_ziad_kasem@dent.asu.edu.eg

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry, Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

DentAinShams

Identifier Type: -

Identifier Source: org_study_id