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

Ain Shams University

Status and phase: Not yet enrolling; Phase 2

Conditions: Postoperative Pain

Treatments: Drug: anti-inflammatory ketorolac tromethamine

Study type: Interventional

Funder types: Other

Identifiers

NCT06584188

DentAinShams

Details and patient eligibility

About

• 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Intra-radicular saline at room temperature

Experimental group

Description:

* Final flush with 20 mL of saline solution * At room temperature for 5 minutes. * Three samples will be collected from periapical fluid .

Treatment:

Drug: anti-inflammatory ketorolac tromethamine