NCT07324915

Brief Summary

Pain management during invasive dental procedures is crucial to avoid noncompliance and treatment avoidance. Thus, measures to reduce injection discomfort are needed to prevent patients from avoiding dental treatment. Tooth extractions, and invasive dental procedures cause pain. Local anesthetics are one of the most effective and safest pain relievers. Even though many children have needle fear, anesthetic may still be uncomfortable. Fear of pain, especially in young children, is real since it affects health outcomes. Anxiety and fear may delay dental treatment and harm the patient's oral health. Distraction, topical anesthetic gel, modifying infiltration rate, intra-oral vibrating devices, computerized delivery systems, pre-cooling injection site, and other pharmacological, physical, and psychological interventions have all been proposed as potential pain relievers. An example of this kind of system One approach that combines an extraoral cold with a vibrating device is Buzzy Bee.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 23, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2026

Completed
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

1 month

First QC Date

December 23, 2025

Last Update Submit

March 6, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • SEM

    Sound, Eye, Motor

    During the delivery of anesthesia

  • WBS

    WONG BAKER SCALE

    During the delivery of anesthesia

  • parental scale

    PARENTAL SCALE

    after administration of anesthesia

Secondary Outcomes (2)

  • PULSE RATE

    Measured three times. 15 minutes before the delivery of anesthesia, b. At the time of delivery of anesthesia and c. 1 minute after the delivery of anesthesia

  • BEHAVIOURAL RATING SCALE

    Measured three times. 15 minutes before the delivery of anesthesia, b. At the time of delivery of anesthesia and c. 1 minute after the delivery of anesthesia

Study Arms (2)

BUZZY BEE

EXPERIMENTAL

Vibrating device

Device: BUZZY BEE [ Vibrating device]

Conventional technique

ACTIVE COMPARATOR

conventional way

Device: Conventional technique

Interventions

already described

Also known as: EXPERIMENTAL
BUZZY BEE

described

Conventional technique

Eligibility Criteria

Age7 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children with no systemic illness, allergies
  • Co-operative child
  • Patient requiring block for dental treatment

You may not qualify if:

  • \. Children with systemic illness and allergy 2. Un co-operative child

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Dentistry

Jizan, Jazan Region, 45142, Saudi Arabia

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 23, 2025

First Posted

January 8, 2026

Study Start

December 22, 2025

Primary Completion

January 28, 2026

Study Completion

March 28, 2026

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations