Buzzy System Compared to Topical Anaesthesia During Infiltration Injection in Children.

Not Applicable

Completed

• Conditions: Local Anaesthesia
• Interventions: Drug: Topical anesthetic; Device: Buzzy System

• Registration Number: NCT05083975
• Lead Sponsor: Cairo University

Brief Summary

Aim of the study is to test the effect of Buzzy System (vibrating device) compared to topical anaesthesia on pain reduction during injection of infiltration anaesthesia in children.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-06
• Study First Submitted QC: 2021-10-18
• Study First Posted: 2021-10-19
• Study Start: 2022-07-23
• Primary Completion: 2022-12-22
• Study Completion: 2023-05-06
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Children classified as cooperative or potentially cooperative according to Wright's classification of child behaviour with rating 3 (positive) or 4 (definitely positive) according to Frankl behaviour rating scale.
2. Children aged 5-8 years old.
3. Patients who need maxillary buccal infiltration anesthesia.

Exclusion Criteria

1. Children with any neurological or psychological disorders.
2. Children with known allergy to topical or local anesthetic agents.
3. Parental refusal for participation.
4. Children with previous history of local anesthesia injection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Topical anesthetic	Maxillary anesthetic infiltration injection using a conventional 2-ml syringe and a short needle after application of 20% Benzocaine topical anesthestic gel.
Buzzy System	Buzzy System	Maxillary anesthetic infiltration injection using a conventional 2-ml syringe and a short needle after activating the buzzy device extra orally proximal to the site of injection for 30-60 seconds.

Primary Outcome Measures

Name	Time	Method
Pain Perception during local anaesthesia injection	Procedure (During and immediately after the administration of local anesthesia)	Pain intensity directly after the injection recorded by Wong-Baker faces pain rating scale and Faces, Legs, Arms, Crying, Consolability (FLACC) scale.

Trial Locations

Locations (1)

Faculty of dentistry, Cairo University; 🇪🇬 Cairo, Manial, Egypt