Cryoanalgesia for Irreversible Pulpitis

Not Applicable

Completed

• Conditions: Pulpitis - Irreversible
• Interventions: Procedure: Cold Mepivacaine; Procedure: Mepivacaine at room temperature

• Registration Number: NCT06268912
• Lead Sponsor: Universitat Internacional de Catalunya

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.

Study Timeline

• Study Start: 2022-09-07
• Primary Completion: 2023-09-07
• Study Completion: 2024-01-07
• Study First Submitted: 2024-01-09
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-16
• Last Update Submitted: 2024-02-16
• Study First Posted: 2024-02-20
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

All Patients within the age group of 18-100 years old,

• Patients diagnosed of irreversible pulpitis.

Read More

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).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cold Mepivacaine	Cold Mepivacaine	Mepivacaine 3% at 5ºC
Mepivacaine at room temperature	Mepivacaine at room temperature	Mepivacaine 3% at room temperature

Primary Outcome Measures

Name	Time	Method
Assessment of Pain and Anxiety	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.

Trial Locations

Locations (1)

Gonzalo Gomez; 🇪🇸 Barcelona, Spain