Effect of External Cold and Vibration (Buzzy Device) Versus the Conventional Technique on Pain Perception During Local Anesthesia Injection in Children.

NCT ID: NCT05067218

Last Updated: 2021-10-05

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2022-11-15

Brief Summary

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This study adopts the null hypothesis (There is no difference in pain perception during local anesthesia injection with the buzzy device in comparison to the conventional technique).

Detailed Description

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The injection of local anesthesia in children is usually associated with fear, anxiety, and discomfort. There is an essential need to develop techniques that decrease pain during injection, preventing patients from avoiding dental treatment.The efficacy of a child-friendly device, having a combined effect of vibration and distraction, with the conventional method of injection on pain, anxiety, and behavior of pediatric patients. The evaluation the pain perception and comfort of the patient during local anesthesia delivery using the Buzzy device and conventional syringe and revealed that the external cold and vibration via Buzzy can reduce pain and anxiety during local anesthetic delivery for various dental procedures.

Conditions

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Anesthesia Anesthesia, Local Vibration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

split mouth
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Blinding of the operator and the patients will not be applicable due to the difference between the used techniques, however, the statistician will be blinded.

Study Groups

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buzzy device (intervention)

The wings of buzzy device will be kept frozen and once the child is ready, the frozen wing will be attached to the device and Buzzy will be placed extra-orally above the area/cheek where local anesthetic is to be delivered.

Group Type ACTIVE_COMPARATOR

buzzy device

Intervention Type DEVICE

bee shaped with wings could be frozen.

Conventinal anasthesia ( control )

* The site of injection will be dried then topical anesthetic gel of 20% benzocaine (Dharma Ophal-S) will be applied. The duration of application of gel will be 1 minute.
* Local anesthetic solution will be delivered using a standard aspirating syringe with 27-gauge, 21 mm short needles.

Group Type EXPERIMENTAL

Conventinal anasthesia

Intervention Type OTHER

normal technique of injection

Interventions

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buzzy device

bee shaped with wings could be frozen.

Intervention Type DEVICE

Conventinal anasthesia

normal technique of injection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children classified as cooperative or potentially cooperative according to Wright's classification of child behaviour.
* Medically fit children (ASA I, II).
* Children mentally capable of communication.
* Children aged 6-11 years.
* First dental visit.
* Patient requiring inferior alveolar nerve block local anesthesia injection for dental treatment.

Exclusion Criteria

* Children with a behavioral management problem.
* Children with known allergy to local anesthetic agents.
* Parental refusal for participation
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mai Gamal Eldeen Hassan Sabra

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Buzzy device in Children.

Identifier Type: -

Identifier Source: org_study_id

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