Different Methods for Reducing Buccal Infiltration Local Anesthesia Injection Pain

NCT ID: NCT06290531

Last Updated: 2024-03-04

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

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-16

Study Completion Date

2023-09-28

Brief Summary

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Local anesthetic injection is considered one of the most annoying dental procedures. The use of topical anesthesia is considered a routine procedure in the dental clinic especially for children. However, the taste and application procedure of the topical gel may not be pleasant for all children.

The introduction of the Buzzy device is considered a distraction measure in the medical field. Alanazi et al., 2019, studied the effect of using the Buzzy device with cold and vibration compared to the conventional infiltration technique using 30-gauge needle. They concluded that the use of the Buzzy device resulted in better patients' acceptance and significantly lower Wong-Baker scores.

Ballard et al., 2019, mentioned in their systematic review the efficacy of the Buzzy device for pain management during needle-related procedures, they concluded that the use of the device may be promising. Ghaderi et al., 2013, evaluated the effect of cooling the injection site on pain perception before infiltration of local anesthetics. They found that cooling the injection site before infiltration of local anesthetics in the buccal mucosa for 1 min, reduced pain perceived by pediatric patients.

Detailed Description

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The investigators used the topical anesthesia, Buzzy device (using vibration only and using cold and vibration) or precooling on pain during buccal infiltration local anesthesia injection.

Conditions

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Dental Caries in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

The statistician was only blinded for data analysis. But it was not feasible to blind the participant, investigator or the outcome assessor due to the nature of the study.

Study Groups

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Buzzy device (cold and vibration)

Group Type EXPERIMENTAL

Buzzy device (cold and vibration)

Intervention Type DEVICE

The device produces cold and vibration to act on the gate control theory and provide painless injection by nerve distraction

Buzzy device (vibration only)

Group Type EXPERIMENTAL

Buzzy device (vibration only)

Intervention Type DEVICE

The device produces vibration to act on the gate control theory and provide painless injection by nerve distraction

Precooling

Group Type EXPERIMENTAL

precooling

Intervention Type OTHER

Ice cubes used for applying coolness at the injection area

Flavored Benzocaine topical anesthetic gel 20%

Group Type ACTIVE_COMPARATOR

Flavored Benzocaine topical anesthetic gel 20%

Intervention Type OTHER

Topical anesthetic gel

Interventions

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Buzzy device (cold and vibration)

The device produces cold and vibration to act on the gate control theory and provide painless injection by nerve distraction

Intervention Type DEVICE

Buzzy device (vibration only)

The device produces vibration to act on the gate control theory and provide painless injection by nerve distraction

Intervention Type DEVICE

precooling

Ice cubes used for applying coolness at the injection area

Intervention Type OTHER

Flavored Benzocaine topical anesthetic gel 20%

Topical anesthetic gel

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children in the mixed dentition stage,
* Age range 6-12 years old,
* Need extraction to a maxillary molar,
* Cooperative and medically free.

Exclusion Criteria

* Exclusion will be performed if the parent refused the participation of their children in the research.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 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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Fatma Abdelgawad

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fatma KI Abdelgawad, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

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Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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CEBD-CU-2023-11-12

Identifier Type: -

Identifier Source: org_study_id

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