Effectiveness of the Buzzy device in decreasing pain during intraoral injection in children

Effectiveness of external cooling and vibration using the Buzzy device in decreasing during inferior alveolar nerve block pain in children aged 6 to 10 years: A randomized controlled clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15002467

Enrollment

100

Registered

2025-07-22

Start date

2025-05-09

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain and anxiety Oral Health

Interventions

Participants were randomly assigned to one of four groups using an online randomization tool, www.randomizer.org, with allocation generated in four equal sets across a number range of 1–100. Upon sea

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Children aged 6–10 years 2. Children requiring local anesthesia for mandibular posterior teeth 3. Children exhibiting positive behavior, rated as "positive" or "definitely positive" on the Frankl Behavior Scale

Exclusion criteria

Exclusion criteria: 1. Children with systemic diseases or a known allergy to local anesthesia or its components 2. Children who refuse to wear the study device 3. Children with a previous history of dental injections

Design outcomes

Primary

Measure	Time frame
1. Pulse rate was objectively measured as an indicator of dental pain and anxiety using a finger pulse oximeter (Alpha, Prolinx GmbH, Düsseldorf, Germany) at baseline (t0) prior to any intervention, and immediately following inferior alveolar nerve block (IANB) administration (t1) 2. Procedural pain during IANB injection was measured using the Face, Legs, Activity, Cry, and Consolability (FLACC) Behavioral Pain Assessment Scale at t1. Video recordings of each procedure were obtained to enable standardized, retrospective scoring by trained outcome assessors. 3. Participants' subjective pain perception was assessed using the Wong-Baker FACES Pain Rating Scale (WBFPS) at t1. Children were instructed to select the facial expression that best represented their pain experience during the procedure, with scores ranging from 0, no pain, to 10, worst pain imaginable.	—

Measure

Time frame

1. Pulse rate was objectively measured as an indicator of dental pain and anxiety using a finger pulse oximeter (Alpha, Prolinx GmbH, Düsseldorf, Germany) at baseline (t0) prior to any intervention, and immediately following inferior alveolar nerve block (IANB) administration (t1) 2. Procedural pain during IANB injection was measured using the Face, Legs, Activity, Cry, and Consolability (FLACC) Behavioral Pain Assessment Scale at t1. Video recordings of each procedure were obtained to enable standardized, retrospective scoring by trained outcome assessors. 3. Participants' subjective pain perception was assessed using the Wong-Baker FACES Pain Rating Scale (WBFPS) at t1. Children were instructed to select the facial expression that best represented their pain experience during the procedure, with scores ranging from 0, no pain, to 10, worst pain imaginable.

—

Secondary

Measure	Time frame
Subjective anxiety levels were measured using the Facial Image Scale (FIS), a 5-point pictorial scale featuring facial expressions ranging from very happy (score = 1) to very fearful (score = 5). Children were instructed to select the face that best represented their emotional state at pre-injection, baseline (t0), and post-IANB administration (t1).	—

Countries

Syria

Contacts

Public ContactMawia Karkoutly

mawia95.karkoutly@damascusuniversity.edu.sy+963 0992647528

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026