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Effectiveness of the Buzzy Device Combined with Nitrous Oxide Sedation in Reducing Dental Anxiety and Pain in Children: A Randomized Controlled Clinical Trial

Effectiveness of the Buzzy Device Combined with Nitrous Oxide Sedation in Reducing Dental Anxiety and Pain in Children: A Randomized Controlled Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00039222
Enrollment
138
Registered
2026-03-06
Start date
2026-03-10
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Dental anxiety and pain in children during local anesthesia.

Interventions

Group 1: Participants receive routine dental treatment under nitrous oxide–oxygen sedation (N2O/O2) and local anesthesia. A visually identical dummy Buzzy device (without vibration or cold) is placed

Sponsors

Department of Pediatric Dentistry, University Medicine Greifswald
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: Children aged 3 to 12 years requiring dental treatment under nitrous oxide (N2O/O2) sedation and local anesthesia. ASA physical status I or II. Written informed consent from parents or legal guardians and assent from the child when appropriate.

Exclusion criteria

Exclusion criteria: Children with neurological, cognitive, or developmental disorders affecting cooperation. ASA physical status III or higher. Contraindications to nitrous oxide sedation or local anesthesia. Refusal to participate by the child or parents/legal guardians.

Design outcomes

Primary

MeasureTime frame
Pain during local anesthesia injection assessed using the Wong-Baker FACES Pain Rating Scale and the FLACC scale, and anxiety assessed using the Venham Behavior Rating Scale during the injection procedure.

Secondary

MeasureTime frame
Pain and anxiety during the entire dental procedure, treatment completion rate, parental assessment of the treatment experience (VAS), and total procedure duration.

Countries

Germany

Contacts

Public ContactRuth Santamaria

Department of Pediatric Dentistry, University Medicine Greifswald

ruth.santamaria@uni-greifswald.de+49 (0)3834 86-7136

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026