EFFECT OF BUZZY BEE TO REDUCE PAIN PERECEPTION DURING INFERIOR ALVEOLAR NERVE BLOCK IN CHILDREN - A CROSS OVER STUDY

Effect of Buzzy Bee to Reduce Pain Perception During Inferior Alveolar Nerve Block in Children - A Cross Over Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pain Management
• Intervention / Treatment: Device: BUZZY BEE [ Vibrating device]; Device: Conventional technique

Detailed Description

Before start of the study a written informed consent will be obtained from each parent of the children included in the study stating they accepted the treatment. The study will be performed among children aged 7 to 9 years and who required inferior alveolar block for their treatment. Children who needed anaesthesia for dental treatment will be randomly divided into two groups Group A and Group B using a lottery randomization technique. control group: the children in this group will be delivered Inferior alveolar nerve block in a conventional way [1 min of topical anaesthesia and local infiltration] Experimental group: A Buzzy external cold and vibrating device will be used on the site of application [right/left face] 2 minutes before anaesthesia and this application will be maintained throughout the injection.

At the first visit, the children in Group A will receive the control intervention and those in group B will receive the experimental intervention. A wash out period of 7 days was observed, after which the second visit will be scheduled. At the second visit, the children in Group A will receive the experimental intervention and Group B will receive the control intervention. Demographic details, informed consent from the parents, and assent from the children will be obtained before the commencement of the study. Outcomes will be recorded as primary and secondary outcomes. primary outcomes includes FLACC, WBS and parental scale where as secondary outcomes will be pulse rate and Frankel behaviour rating scale.

Pulse rate will be recorded before anaesthesia, during anaesthesia and 1 min after delivery of anaesthesia, Frankel behaviour rating scale will be measured before, during and after anaesthesia procedures. FLACC and WBS scales will be used to objectively and subjectively record the pain perception. parental scale will be used to determine parental view regarding pain scale during anaesthesia procedure.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Jazan Region
    • Jizan, Jazan Region, Saudi Arabia, 45142
      • College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria

1. Healthy children with no systemic illness, allergies
2. Co-operative child
3. Patient requiring block for dental treatment
4. children with proper parental consent Exclusion criteria

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BUZZY BEE; Vibrating device	Device: BUZZY BEE [ Vibrating device]; already described; Other Names: EXPERIMENTAL
Active Comparator: Conventional technique; conventional way	Device: Conventional technique; described

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PULSE RATE	Pulse rate examined with a pulse oximeter	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	Behaviour was measured using behaviour rating scale either definitely negative, negative, positive or positive behaviour	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

Collaborators and Investigators

• Sponsor: University of Jazan

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2025
• Primary Completion (Actual): January 28, 2026
• Study Completion (Estimated): March 28, 2026

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia
• Other Study ID Numbers: COLLEGE OF DENTISTRY jazan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No