Cryoanalgesia for Irreversible Pulpitis

Pulpitis - Irreversible Clinical Trial

— CryPain  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06268912
• Other study ID #: END-ECL-2022-01
• Secondary ID: END-ECL-2022-01
• Status: Completed
• Phase: N/A
• Start date: September 7, 2022
• Est. completion date: January 7, 2024

Study information

• Verified date: February 2024
• Source: Universitat Internacional de Catalunya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 7, 2024
• Est. primary completion date: September 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pulpitis
• Pulpitis - Irreversible

Intervention

Procedure:
• Cold Mepivacaine
change the temperature, 3% at 5ºC
• Mepivacaine at room temperature
no change the temperature of anesthesia

Locations

Country	Name	City	State
Spain	Gonzalo Gomez	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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