The Success Rate of Cryotherapy Application in Primary Molars With Signs of Irreversible Pulpitis

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-22

Study Completion Date

2022-04-30

Brief Summary

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The study is designed as a randomized controlled trial with two parallel groups. Children aged 5-9 years with primary molars from suffered symptomatic signs of irreversible pulpitis will be randomly assigned into two groups. The first group (experimental group) will be injected with 4% articaine 1:100.000 epinephrine (inferior alveolar nerve block). For the second group, the mandibular second primary molars will be anesthetized using 4% articaine 1:100.000 epinephrine using inferior alveolar nerve block.

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Detailed Description

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Conditions

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Pain, Procedural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cryotherapy during inferior alveolar nerve block

Group Type EXPERIMENTAL

Cryotherapy

Intervention Type OTHER

local anesthetic injection with articaine 4% 1:100,000 epinephrine then an application ice packs

Inferior alveolar nerve block

Group Type ACTIVE_COMPARATOR

Traditional local anesthesia

Intervention Type OTHER

local anesthetic injection with articaine 4% 1:100,000 epinephrine

Interventions

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Cryotherapy

local anesthetic injection with articaine 4% 1:100,000 epinephrine then an application ice packs

Intervention Type OTHER

Traditional local anesthesia

local anesthetic injection with articaine 4% 1:100,000 epinephrine

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy children are classified as I or II according to ASA
* Presence of at least one mandibular primary molar with symptomatic signs of irreversible pulpitis
* Presence of at least two-thirds of the root length in periapical radiograph

Exclusion Criteria

* Unrestorable crowns
* Children with systemic, severe behavior or emotional problems
* Presence of gingival redness, swellings, fistulous of sinus tract
* Radiographic evidence of internal root resorption, pulp stones or calcifications, and/or bone radiolucency

Minimum Eligible Age

5 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes