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Completed

NCT Number: NCT06268912

Cryoanalgesia for Irreversible Pulpitis

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.

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Key information

Conditions

Pulpitis - Irreversible Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gonzalo Gomez

Barcelona, 08, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Cold Mepivacaine

Procedure

change the temperature, 3% at 5ºC

Mepivacaine at room temperature

Procedure

no change the temperature of anesthesia

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Universitat Internacional de Catalunya

Other

Registry information

Official study title

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

Acronym: CryPain

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 20, 2024
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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