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

NCT ID: NCT07324915

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-22
• Study Completion Date: 2026-01-28

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.

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.

Conditions

Pain Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BUZZY BEE

Vibrating device

Group Type: EXPERIMENTAL

BUZZY BEE [ Vibrating device]

Intervention Type: DEVICE

already described

Conventional technique

conventional way

Group Type: ACTIVE_COMPARATOR

Conventional technique

Intervention Type: DEVICE

described

Interventions

BUZZY BEE [ Vibrating device]

already described

Intervention Type: DEVICE

Conventional technique

described

Intervention Type: DEVICE

Other Intervention Names

EXPERIMENTAL

Eligibility Criteria

Inclusion Criteria

1. Healthy children with no systemic illness, allergies

2. Co-operative child

3. Patient requiring block for dental treatment

Exclusion Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Jazan

OTHER_GOV

Sponsor Role: lead

Responsible Party

satish vishwanathaiah

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

College of Dentistry

Jizan, Jazan Region, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

COLLEGE OF DENTISTRY jazan

Identifier Type: -

Identifier Source: org_study_id