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Not yet recruiting NCT06584188

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

Phase II Interventional Postoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: anti-inflammatory ketorolac tromethamine.
Who it may be relevant to
Registry conditions: Postoperative Pain. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

* 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

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

Primary outcome measures

  • Level of pre-operative pain. [Time frame: before start the operative]
  • Level of Post-operative pain. [Time frame: 6 hours post operative]
  • Level of Post-operative pain. [Time frame: 24 hours post operative]
  • Level of Post-operative pain. [Time frame: 48 hours post operative]
  • Level of Post-operative pain. [Time frame: 72 hours post operative]
Secondary outcome measures (3)
  • Level of substance P expression. [Time frame: 15 minutes following access cavity preparation.]
  • Level of substance P expression. [Time frame: 30 minutes following access cavity preparation.]
  • Level of substance P expression. [Time frame: Immediately prior to obturation]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Dentistry, Ain Shams University — Cairo

Identifiers

NCT: NCT06584188 · DentAinShams

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗