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Clinical Trials/NCT06268912
NCT06268912
Completed
Not Applicable

Cryoanalgesia: Temperature Modulation for Pain Management in Irreversible Pulpitis a Randomized Clinical Trial

Universitat Internacional de Catalunya1 site in 1 country20 target enrollmentSeptember 7, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulpitis - Irreversible
Sponsor
Universitat Internacional de Catalunya
Enrollment
20
Locations
1
Primary Endpoint
Assessment of Pain and Anxiety
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The aim of the present study was to evaluate the effectiveness of pulpal anesthesia in pain control during endodontic treatment by lowering the temperature of the injected plain 3% cold Mepivacaine (5ºC) compared to 3% Mepivacaine at room temperature in teeth with irreversible pulpitis.

Detailed Description

Mepivacaine has some advantages over other anesthetics. The investigators wanted to compare whether changing temperature could improve its effectiveness in cases of irreversible pulpitis.

Registry
clinicaltrials.gov
Start Date
September 7, 2022
End Date
January 7, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gonzalo Gómez Val

Clinical Professor

Universitat Internacional de Catalunya

Eligibility Criteria

Inclusion Criteria

  • All Patients within the age group of 18-100 years old,
  • Patients diagnosed of irreversible pulpitis.

Exclusion Criteria

  • Moderate to pulp necrosis,
  • Previous initiated treatment.
  • Pregnancy or lactation.
  • Allergy or problems to any substances used in the study,
  • Acute apical abscess.
  • Chronic apical abscess.
  • Unrestorable teeth.
  • Unsuccessful anesthesia technique (no lip numbness for lower molars or positive response to cold test).

Outcomes

Primary Outcomes

Assessment of Pain and Anxiety

Time Frame: 1 visit of 1 hour

Pain during injection, caries removal, access cavity, and instrumentation were recorded. The patients received a full description of the procedure, and patients were asked to rate their current pain and their anxiety with a descriptive scale (Heft-Parker Visual Analog Scale (VAS) before starting the treatment. A visual analog scale of 170 mm that the start points on the left side means "no pain" and the endpoint on the right side means "severe pain". The participants indicated their pain level by marking a point on the scale that best represented their experience. For data interpretation, the Visual Analog Scale (VAS) was segmented into four categories: no pain corresponded to 0 mm on the scale, mild pain as greater than 0 and ≤54mm, moderate pain defined as greater than 54 mm and less than 114 mm and severe pain defined as 114 mm or more.

Study Sites (1)

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