Cold Vibratory Stimuli on Pain Perception Governing Infiltration Anesthesia in 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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-05

Study Completion Date

2023-05-20

Brief Summary

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Local anesthesia injections are sometimes painful, resulting in antagonistic cooperation, fear, and anxiety in children. This study aims to investigate the effectiveness of vibratory and cold stimulation before the injection to reduce pain. Purpose of the study: Evaluate the effectiveness of Buzzy® in pain reduction during local anesthesia administration compared to the traditional topical anesthetic gel in pediatric patients.

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Detailed Description

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Conditions

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Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The Participants will be randomly and equally allocated into 2 groups with 2 subgroups each

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Direct local anesthesia with Buzzy

Group Type EXPERIMENTAL

Buccal and direct palatal injection with the aid of Buzzy

Intervention Type OTHER

Children are assigned to local anesthesia after using the Buzzy vibration unit extraorally for 2 minutes using buccal and direct palatal injection

Indirect local anesthesia with Buzzy

Group Type EXPERIMENTAL

Buccal and indirect palatal injection with the aid of Buzzy

Intervention Type OTHER

Children are assigned to local anesthesia after using the Buzzy vibration unit extraorally for 2 minutes using buccal and indirect palatal injection

Direct local anesthesia

Group Type ACTIVE_COMPARATOR

Buccal and direct palatal injection without Buzzy

Intervention Type OTHER

Children are assigned to local anesthesia after using topical analgesic gel (benzocaine 20%) intraorally for 1 minute using buccal and direct palatal injection

Indirect local anesthesia

Group Type ACTIVE_COMPARATOR

Buccal and indirect palatal injection without Buzzy

Intervention Type OTHER

Children are assigned to local anesthesia after using topical analgesic gel (benzocaine 20%) intraorally for 1 minute using buccal and indirect palatal injection

Interventions

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Buccal and direct palatal injection with the aid of Buzzy

Children are assigned to local anesthesia after using the Buzzy vibration unit extraorally for 2 minutes using buccal and direct palatal injection

Intervention Type OTHER

Buccal and indirect palatal injection with the aid of Buzzy

Children are assigned to local anesthesia after using the Buzzy vibration unit extraorally for 2 minutes using buccal and indirect palatal injection

Intervention Type OTHER

Buccal and direct palatal injection without Buzzy

Children are assigned to local anesthesia after using topical analgesic gel (benzocaine 20%) intraorally for 1 minute using buccal and direct palatal injection

Intervention Type OTHER

Buccal and indirect palatal injection without Buzzy

Children are assigned to local anesthesia after using topical analgesic gel (benzocaine 20%) intraorally for 1 minute using buccal and indirect palatal injection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who are in need of extraction of maxillary posterior teeth.
* Children free of any systemic disease or special health care needs (ASA I).
* Children with no learning disabilities.
* Positive or definitely positive behavior during preoperative assessments according to the Frankl Scale.
* Patients whose parents will give consent to participate.

Exclusion Criteria

* Having active sites of pathosis in the area of injection that could affect the anesthetic assessment.
* Signs of reversible pulpitis.
* Restorable tooth.
* Patients allergic to local anesthesia or having a family history of allergy to local anesthesia.
* Patients with acute oral or facial infection (swelling and/or cellulites )

Minimum Eligible Age

5 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No