Different Methods for Reducing Buccal Infiltration Local Anesthesia Injection Pain

Not Applicable

Completed

• Conditions: Dental Caries in Children
• Interventions: Device: Buzzy device (vibration only); Other: precooling; Device: Buzzy device (cold and vibration); Other: Flavored Benzocaine topical anesthetic gel 20%

• Registration Number: NCT06290531
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-01-16
• Primary Completion: 2023-09-28
• Study Completion: 2023-09-28
• Study First Submitted: 2024-01-29
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-26
• Last Update Submitted: 2024-02-26
• Study First Posted: 2024-03-04
• Last Update Posted: 2024-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

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

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Exclusion Criteria

• Exclusion will be performed if the parent refused the participation of their children in the research.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buzzy device (vibration only)	Buzzy device (vibration only)	-
Precooling	precooling	-
Buzzy device (cold and vibration)	Buzzy device (cold and vibration)	-
Flavored Benzocaine topical anesthetic gel 20%	Flavored Benzocaine topical anesthetic gel 20%	-

Primary Outcome Measures

Name	Time	Method
Patient reported pain during needle injection	Immediately post injection	Patient was asked to choose from the faces on the Wong Baker faces pain rating scale (0-10) with 10 is the worst score

Secondary Outcome Measures

Name	Time	Method
Child behaviour during needle injection	Immediately during injection	Child behaviour during needle injection was recorded using Sound-eye-motor scale (0-9) with 9 is the worst score
Heart rate	Immediately post injection	Heart rate was recorded using pulse oximetry (beats/minute)
Oxygen saturation	Immediately post injection	Oxygen saturation was recorded using pulse oximetry
Child and parent satisfaction	Immediately post injection	By asking questions to both child and their parent on a likert scale for children ( positive, neutral and negative) for parents ( strongly agree, agree, no opinion, disagree and strongly disagree)

Trial Locations

Locations (1)

Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, Egypt