Buzzy Bee for Pain and Anxiety Control During Pediatric Dental Local Anesthesia

NCT07886333 | Recruiting DMC

• 1 other identifier: #P-PED-5-25-3378
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The present study will evaluate the effectiveness of Buzzy Bee in reducing pain and physiological responses during maxillary buccal infiltration in children aged 5-7 years compared with a conventional injection protocol.

Conditions

Anxiety; Pain; Children; Anesthesia

Keywords

Buzzy Bee Device; local anesthesia; dental anxiety; pain control; crossover

Outcome Measures

Primary Outcomes (1)

• Self-Reported Pain Intensity (Wong-Baker FACES® Pain Rating Scale)

  Subjective pain intensity assessed using the validated Wong-Baker FACES® Pain Rating Scale. The scale features six facial expressions ranging from 0 ("No Hurt") to 10 ("Hurts Worst") in increments of 2 (0, 2, 4, 6, 8, 10). Following local anesthesia administration, the child is seated upright and points to the face that best represents their pain intensity experienced during needle insertion. Higher scores represent higher pain intensity.

  Immediately post-injection (approx. 5 min post-baseline) at Visit 1 (Day 0) and Visit 2 (Day 7)

Secondary Outcomes (2)

• Physiological Anxiety / Stress Response (Heart Rate)

  Baseline (2 minutes pre-injection), during injection (approx. 2-3 minutes post-baseline), and post-injection (approx. 5 minutes post-baseline) at Visit 1 (Day 0) and Visit 2 (Day 7).

• Behavioral Pain Expression (FLACC Scale)

  During the local anesthesia administration procedure (approx. 2 to 3 minutes post basline) at Visit 1 (Day 0) and Visit 2 (Day 7).

Study Arms (2)

Sequence AB (Buzzy® Bee First, Then Conventional)

EXPERIMENTAL

Participants in Sequence AB receive Buzzy® Bee-assisted maxillary buccal infiltration local anesthesia during the first visit (Period 1). After a 1-week washout period, the same participants receive local anesthesia using the conventional administration technique during the second visit (Period 2).

Device: Intervention A: Buzzy® Bee-Assisted Local Anesthesia; Drug: Intervention B: Conventional Local Anesthesia Technique

Sequence BA (Conventional First, Then Buzzy® Bee)

EXPERIMENTAL

Participants in Sequence BA receive conventional maxillary buccal infiltration local anesthesia during the first visit (Period 1). After a 1-week washout period, the same participants receive Buzzy® Bee-assisted local anesthesia during the second visit (Period 2).

Device: Intervention A: Buzzy® Bee-Assisted Local Anesthesia; Drug: Intervention B: Conventional Local Anesthesia Technique

Interventions

Intervention A: Buzzy® Bee-Assisted Local Anesthesia DEVICE

Behavioral Guidance: Child preparation using the Tell-Show-Do technique. Device Application: The Buzzy® Bee device (equipped with pre-frozen wings) is activated to provide combined high-frequency vibration and cryotherapy. It is placed on the extraoral cheek skin approximately 1-2 cm proximal to the target injection site for 30 seconds prior to needle insertion and remains continuously active throughout needle insertion and solution deposition. Topical Anesthesia: Injection site is isolated with cotton rolls, dried, and treated with 2% Lidocaine gel applied for 2 minutes via a sterile cotton swab. Local Anesthesia Injection: Maxillary buccal infiltration is delivered using 4% Articaine with 1:200,000 epinephrine via a sterile short 27-gauge needle, deposited slowly over 60 seconds while Buzzy® Bee is running.

Sequence AB (Buzzy® Bee First, Then Conventional); Sequence BA (Conventional First, Then Buzzy® Bee)

Intervention B: Conventional Local Anesthesia Technique DRUG

Behavioral Guidance: Child preparation using standard Tell-Show-Do behavioral guidance paired with routine audiovisual distraction (cartoons displayed on a chair-side screen). Topical Anesthesia: Identical protocol to Intervention A (site isolation, drying, and 2% Lidocaine gel application for 2 minutes). Local Anesthesia Injection: Maxillary buccal infiltration delivered using 4% Articaine with 1:200,000 epinephrine via a sterile short 27-gauge needle, deposited slowly over 60 seconds using identical technique, volume, and rate as Intervention A, but without external vibration or cryotherapy application.

Sequence AB (Buzzy® Bee First, Then Conventional); Sequence BA (Conventional First, Then Buzzy® Bee)

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

faculty of dentistry, Tanta university

Tanta, Egypt

RECRUITING

Related Publications (2)

• Shilpapriya M, Jayanthi M, Reddy VN, Sakthivel R, Selvaraju G, Vijayakumar P. Effectiveness of new vibration delivery system on pain associated with injection of local anesthesia in children. J Indian Soc Pedod Prev Dent. 2015 Jul-Sep;33(3):173-6. doi: 10.4103/0970-4388.160343.

  PMID: 26156269 RESULT

• Hegde KM, R N, Srinivasan I, D R MK, Melwani A, Radhakrishna S. Effect of vibration during local anesthesia administration on pain, anxiety, and behavior of pediatric patients aged 6-11 years: A crossover split-mouth study. J Dent Anesth Pain Med. 2019 Jun;19(3):143-149. doi: 10.17245/jdapm.2019.19.3.143. Epub 2019 Jun 30.

  PMID: 31338420 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Pain; Agnosia

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Central Study Contacts

shaimaa eldesouky, assistant professor

CONTACT

01008994242; shaimaaeldesouky@dent.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of pediatric dentistry

Study Record Dates

• First Submitted: October 12, 2026
• First Posted: October 21, 2026
• Study Start: August 1, 2025
• Primary Completion: October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 21, 2026

Record last verified: 2026-10

Locations

EG (1)