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Completed

NCT Number: NCT05083975

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

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.

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Key information

Conditions

Local Anaesthesia

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry, Cairo University

Cairo, Manial, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Children aged 5-8 years old.
  • Patients who need maxillary buccal infiltration anesthesia.

Exclusion criteria

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

Treatment and study plan

Buzzy System

Device

Vibrating Device

Topical anesthetic

Drug

20% benzocaine gel (Opahl Topical Gel)

1.8 ml of 4% articaine hydrochloride with epinephrine 1:100,000

Drug

Local dental anesthetic agent

Primary outcomes

  1. Pain Perception during local anaesthesia injection

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Buzzy System (Vibrating Device) Compared to Topical Anaesthesia on Pain Reduction During Injection of Infiltration Anaesthesia in Children: A Randomized Clinical Trial.

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Oct 19, 2021
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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