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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06584188

Enrollment

Registered

2024-09-04

Start date

2026-04-11

Completion date

2026-04-30

Last updated

2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

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

Interventions

DRUGanti-inflammatory ketorolac tromethamine

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

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Level of pre-operative pain.	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)
Level of Post-operative pain.	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)

Secondary

Measure	Time frame	Description
Level of substance P expression.	15 minutes following access cavity preparation.	Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 16, 2026