Cryotherapy Efficacy During Pulp Therapy of the Mandibular First Permanent Molars in Children

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

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2022-08-31

Brief Summary

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The aim of the study is to assess the efficacy of cryotherapy application on the success of inferior alveolar nerve block (IANB) in reducing pain during pulp therapy of the mandibular first permanent molars with irreversible pulpitis (IP) in children age from 7 to 16 years. The null hypothesis (H0) supposed no difference in pain intensity during pulp therapy of primary molars with IP anesthetized with IANB with and without cryotherapy application. The secondary aim was to evaluate the children's behavior before and after pulpectomy in the two groups.

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Detailed Description

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Conditions

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Cryotherapy Effect Irreversible Pulpitis Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cryotherapy

Group Type EXPERIMENTAL

Cryotherapy

Intervention Type OTHER

Ice packs were applied in the buccal mucosa related to the tooth for 5 minutes after IANB administration

Inferior alveolar nerve block

Group Type ACTIVE_COMPARATOR

Cryotherapy

Intervention Type OTHER

Ice packs were applied in the buccal mucosa related to the tooth for 5 minutes after IANB administration

Interventions

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Cryotherapy

Ice packs were applied in the buccal mucosa related to the tooth for 5 minutes after IANB administration

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy children aged 9-17 years who were categorized as class I or II according to the ASA classification.
* Cooperative children (rate 3 or 4 according to Frankl behavior rating scale)
* Presence of a vital mandibular first permanent molar with SIP, the tooth should show deep caries or dental restorations with a history of spontaneous lingered pain precipitated by thermal stimuli. To confirm the diagnosis of irreversible pulpitis, early response to electric pulp and thermal testing was performed.
* No radiographic changes with at least two-thirds of the root must be evident.

Exclusion Criteria

* Children with severe emotional, intellectual, and behavioral difficulties.
* Necrotic pulp of primary molars.
* Unrestorable crowns
* Positive history of gingival swelling, abnormal mobility, and fistulous tract.
* Presence of radiographic signs of periapical and/or furcation radiolucency, and pathological resorption.

Minimum Eligible Age

9 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes