Cryoanalgesia for Irreversible Pulpitis

NCT06268912 | Completed DMC

• 1 other identifier: END-ECL-2022-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulpitis - Irreversible

Keywords

Cryoanalgesia; Irreversible Pulpitis; Pain Management

Outcome Measures

Primary Outcomes (1)

• Assessment of Pain and Anxiety

  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.

  1 visit of 1 hour

Study Arms (2)

Cold Mepivacaine

EXPERIMENTAL

Mepivacaine 3% at 5ºC

Procedure: Cold Mepivacaine

Mepivacaine at room temperature

ACTIVE COMPARATOR

Mepivacaine 3% at room temperature

Procedure: Mepivacaine at room temperature

Interventions

Cold Mepivacaine PROCEDURE

change the temperature, 3% at 5ºC

Cold Mepivacaine

Mepivacaine at room temperature PROCEDURE

no change the temperature of anesthesia

Mepivacaine at room temperature

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Gonzalo Gomez

Barcelona, 08, Spain

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• gonzalo gomez

  UIC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: February 20, 2024
• Study Start: September 7, 2022
• Primary Completion: September 7, 2023
• Study Completion: January 7, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

ES (1)