Buzzy Bee for Pain and Anxiety Control During Pediatric Dental Local Anesthesia
Official title: Effectiveness of Buzzy Bee Device in Anxiety Reduction and Pain Control During Local Anesthesia Administration
Run by Tanta University · NCT07886333 · Data updated 2026-11-12
This study tests whether the Buzzy Bee device, with cold and vibration, reduces pain and anxiety during a dental injection in kids aged 5-7 compared with standard distraction.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 5 Years to 7 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | October 2026 |
| Study ends | November 2026 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT07886333 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 5-7 who are ASA-I, cooperative (Frankl 3-4), require bilateral maxillary buccal infiltration across at least two visits, and have no neurological or psychological disorders.
✕Probably not a fit
Children with low cooperation (Frankl 1-2), neurological or psychological disorders, acute dental pain at the injection site, or allergies to local anesthetics may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this randomized crossover trial, 40 healthy children aged 5-7 will receive two maxillary buccal infiltrations, one with the Buzzy Bee device and one with a conventional technique, across two visits separated by one week. Each visit uses topical lidocaine, followed by 4% articaine with epinephrine, with outcome measures including heart rate and pain scores (FLACC and Wong-Baker). The order of interventions is AB or BA, and a crossover design allows each child to serve as their own control. The study aims to determine if Buzzy Bee can reduce physiological arousal and reported pain during local anesthesia in pediatric patients. Primary setting is the Outpatient Clinic of the Pediatric Dentistry Department, Faculty of Dentistry, Tanta University, with ASA-I healthy children and cooperative behavior required.
Why it matters
Potential benefit: If successful, the Buzzy Bee approach could lessen pain and anxiety during dental injections, improving cooperation and reducing avoidance of future dental care.
How similar studies have gone: Prior studies in pediatric dentistry have explored vibration and distraction for pain relief; results are mixed but supportive of non-pharmacologic aids in reducing discomfort.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Systemically healthy children classified as ASA-I. * Children requiring bilateral maxillary buccal infiltration local anesthesia across at least two separate dental treatment appointments. * Co-operative child with a Frankl behavior rating of 3,4. * Children free from any neurological or psychological disorder. Exclusion Criteria: * Children with known allergy to local anesthetic agents. * Children with developmental delays, intellectual disabilities, or severe uncooperative behavior (Frankl rating 1 or 2). * Children presenting with acute dental pain, swelling, or active infection at the injection site. * Parental refusal to provide written informed consent for participation
Where it's running
-
faculty of dentistry, Tanta university
Tanta, Egypt Recruiting
Study contacts
- Study coordinator: shaimaa eldesouky, assistant professor
- Email: shaimaaeldesouky@dent.tanta.edu.eg
- Phone: 01008994242
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.