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

Phase 2

Not yet recruiting

• Conditions: Postoperative Pain
• Interventions: Drug: anti-inflammatory ketorolac tromethamine

• Registration Number: NCT06584188
• Lead Sponsor: Ain Shams University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-11
• Study First Submitted QC: 2024-09-01
• Last Update Submitted: 2024-09-01
• Study First Posted: 2024-09-04
• Last Update Posted: 2024-09-04
• Study Start: 2024-11-01
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intra-radicular saline at room temperature	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 .

Primary Outcome Measures

Name	Time	Method
Level of Post-operative pain.	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)

Secondary Outcome Measures

Name	Time	Method
Level of substance P expression.	Immediately prior to obturation	Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab.

Trial Locations

Locations (1)

Faculty of Dentistry, Ain Shams University; 🇪🇬 Cairo, Egypt