Cryoanalgesia for Irreversible Pulpitis

NCT ID: NCT06268912

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-07

Study Completion Date

2024-01-07

Brief Summary

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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

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

Conditions

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Pulpitis - Irreversible

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cold Mepivacaine

Mepivacaine 3% at 5ºC

Group Type EXPERIMENTAL

Cold Mepivacaine

Intervention Type PROCEDURE

change the temperature, 3% at 5ºC

Mepivacaine at room temperature

Mepivacaine 3% at room temperature

Group Type ACTIVE_COMPARATOR

Mepivacaine at room temperature

Intervention Type PROCEDURE

no change the temperature of anesthesia

Interventions

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Cold Mepivacaine

change the temperature, 3% at 5ºC

Intervention Type PROCEDURE

Mepivacaine at room temperature

no change the temperature of anesthesia

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitat Internacional de Catalunya

OTHER

Sponsor Role lead

Responsible Party

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Gonzalo Gómez Val

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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gonzalo gomez

Role: PRINCIPAL_INVESTIGATOR

UIC

Locations

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Gonzalo Gomez

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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END-ECL-2022-01

Identifier Type: OTHER

Identifier Source: secondary_id

END-ECL-2022-01

Identifier Type: -

Identifier Source: org_study_id

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