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Cryoanalgesia for Irreversible Pulpitis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06268912
Acronym
CryPain
Enrollment
20
Registered
2024-02-20
Start date
2022-09-07
Completion date
2024-01-07
Last updated
2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulpitis - Irreversible

Keywords

Cryoanalgesia, Irreversible Pulpitis, Pain Management

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.

Interventions

PROCEDURECold Mepivacaine

change the temperature, 3% at 5ºC

PROCEDUREMepivacaine at room temperature

no change the temperature of anesthesia

Sponsors

Universitat Internacional de Catalunya
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Assessment of Pain and Anxiety1 visit of 1 hourPain 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026