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Comparison of Buzzy Bee and Vibradent Devices to Reduce Pain and Anxiety in Children During Dental Injections for Tooth Removal

Comparative evaluation of acceptability feasibility and satisfaction of buzzy bee and vibradent in relieving pain and anxiety during local anaesthesia administration during dental extraction A randomised controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092560
Enrollment
126
Registered
2025-08-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: K029- Dental caries, unspecified

Interventions

Intervention1: BUZZY BEE: It is vibrotactile and cryotherapy based device for reducing the pain perception during local anesthesia administration. The intervention duration was approximately 2 to 3 mi

Sponsors

Government dental college and hospital srinagar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Cooperative patients with positive behaviour according to Frankel behaviour rating scale (FBRS). 2) Should be first visit of the patient to the dental clinic. 3) 7 to 10-year-old children. 4) Patient who needs local anaesthesia, either maxillary infiltration or mandibular nerve block for extraction. 5) Free from any psychological and neurological disorder (Autism, Attention deficit hyperactivity disorder).

Exclusion criteria

Exclusion criteria: 1) Patients with congenital diseases. 2) Patients with respiratory diseases. 3) Medically compromised patients. 4) Children with significantly altered emotional state. 5) Children unable to quantify pain. 6) No history of drug allergy.

Design outcomes

Primary

MeasureTime frame
1)Compare vibradent and buzzy bee on reducing pain during LA administration in paediatric dental patients using WBFPS FLACC SEM scales at baseline(T0) at needle insertion(Tn) and three minutes after LA(Te) 2)Compare anxiety levels using FIS Heart rate and salivary cortisol 3) Compare their efficacy between local infiltration and nerve blockTimepoint: 10 minutes Before anaesthesia administration During anaesthesia administration 10 minutes after anaesthesia administration

Secondary

MeasureTime frame
1) To evaluate parent & patient acceptance & satisfaction using questionnaire. 2) To assess feasibility of the procedure by calculating time required to complete the procedure. Timepoint: 10 mins

Countries

India

Contacts

Public ContactDr Shajaratul yakeen nabi

Government dental college and hospital srinagar

lonenazia1@gmail.com9419060028

Outcome results

None listed

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