The Effect of Vibration Devices on Pain and Discomfort During Local Anesthesia Administration in Children

NCT07384923 | Not Yet Recruiting FDA Device

• 1 other identifier: KingAbdulaizU
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This split-mouth randomized clinical trial will be conducted at the Department of Pediatric Dentistry, King Abdulaziz University Dental Hospital (KAAUDH). The inclusion criteria will include healthy, non-anxious, cooperative children aged six to 12 who require non-urgent dental treatment involving at least one pair of contralateral maxillary molars needing buccal infiltration anesthesia with no previous dental history or experience. The children will be screened for eligibility, and a single trained dental intern will approach the parents or guardians of eligible children. Those who agree to be screened for participation in the study will be asked to sign an Arabic consent form. Before the scheduled screening appointment, children's anxiety levels will be assessed using a high score on the Abeer Children Dental Anxiety Scale (ACDAS) in the waiting area. During the appointment, a single trained dental intern will perform the dental examination and prophylaxis, while two trained and calibrated dental interns will assess children's behavior using the Frankl Behavior Rating Scale. Children found to be non-anxious based on their ACDAS score and cooperative or definitely cooperative based on the Frankl Behavior Rating Scale will be considered eligible for the study. Two treatment appointments will be scheduled for them, and consent and assent forms for participation in the study will be obtained. Computer randomization will be performed to determine the treatment sequence (DentalVibe intraoral vibration device followed by Buzzy Bee® extraoral vibration device, or vice versa) and the site (right or left). Randomization will be performed before the first scheduled treatment appointment. The subjects will be seated in the dental chair for five minutes to acclimate to the environment. To measure the physiological changes of the participating subjects, a pulse oximeter device (OxyWatch, ChoiceMMed, Hamburg, Germany) will be applied, and a trained dental intern will record the baseline heart rate (HR). During the treatment, HR will also be recorded. The tip of the DentalVibe intraoral vibration device will be gently placed on the mucobuccal fold above the tooth to be anesthetized. In contrast, the Buzzy Bee® extraoral vibration device will be positioned externally above the buccal infiltration site. During maxillary buccal infiltration, all subjects will be videotaped using a high-resolution camera, focusing on the face and body. Later, two trained and calibrated evaluators will independently assess the child's behavior during the procedure using the Face, Legs, Activity, Cry, Consolability Scale (FLACC) Immediately after administering anesthesia, the subjects will be positioned upright, and the same trained dental intern will introduce the face version of the Visual Analogue Scale (VAS). Finally, after completing both procedures, the subjects will be asked about their future preference for the vibration device. Due to the study's design, both the investigator administering the maxillary buccal infiltration and the subjects will not be aware of which group they belong to.

Conditions

Physiological Changes (Heart Rate); Obejective Pain and Discomfort; Subjective Pain and Discomfort; Subjects' and Parents' Satisfaction; Subjects' and Parents' Future Preference; Children's Anxiety Levels; Children's Behavior

Keywords

Pain and discomfort; future preferece; satisfaction; Vibration Device

Outcome Measures

Primary Outcomes (3)

• Physiological changes (heart rate(HR))

  Physiological changes (HR) of the participating subjects will be measured using a pulse oximeter device (OxyWatch, ChoiceMMed, Hamburg, Germany), and a trained dental intern will record it.

  HR will be recorded at: 1- At baseline, onc subjects sat in the dental chair 2- At the application of topical anesthesia 3- At the activation of the vibration device 4- At needle insertion 5- Immediately after the needle is withdrawn.

• The subject's subjective pain and discomfort.

  Visual Analogue Scale (VAS), which assesses the subject's subjective pain and discomfort. The scale is a 10-cm line that indicates the level of pain and discomfort, with zero representing no pain and 10 representing the worst possible pain.

  Immediately after the anesthesia administration

• Objective pain and discomfort

  Two trained and calibrated evaluators independently assessed the child's objective pain and discomfort during the procedure using the Face, Legs, Activity, Cry, Consolability Scale (FLACC). The FLACC scale ranges from 0 to 10, with 0 indicating no pain and 10 the worst possible pain.

  During the anesthesia administration

Secondary Outcomes (1)

• Subjects' and parents' satisfaction with each dental vibration device

  Immediately after both vibration devices.

Study Arms (4)

The DentalVibe vibration device first on the right side then the Buzzy Bee® vibration device

OTHER

The DentalVibe intraoral vibration device first on the right side then the Buzzy Bee® extraoral vibration device on the left Side.

Device: DentalVibe intraoral vibration device; Device: Buzzy Bee® extraoral vibration device

The DentalVibe vibration device first on the left side then the Buzzy Bee® vibration device

OTHER

The DentalVibe intraoral vibration device is first on the left side, then the Buzzy Bee® extraoral vibration device on the right Side.

Device: DentalVibe intraoral vibration device; Device: Buzzy Bee® extraoral vibration device

The Buzzy Bee® vibration device first on the right side then the DentalVibe vibration device

OTHER

The Buzzy Bee® extraoral vibration device is first on the right side, then the DentalVibe intraoral vibration device on the left Side

Device: DentalVibe intraoral vibration device; Device: Buzzy Bee® extraoral vibration device

The Buzzy Bee® vibration device first on the left side, then the DentalVibe vibration device

OTHER

The Buzzy Bee® extraoral vibration device is first on the left side, then the DentalVibe intraoral on the right side.

Device: DentalVibe intraoral vibration device; Device: Buzzy Bee® extraoral vibration device

Interventions

DentalVibe intraoral vibration device DEVICE

DentalVibe intraoral vibration device.

The Buzzy Bee® vibration device first on the left side, then the DentalVibe vibration device; The Buzzy Bee® vibration device first on the right side then the DentalVibe vibration device; The DentalVibe vibration device first on the left side then the Buzzy Bee® vibration device; The DentalVibe vibration device first on the right side then the Buzzy Bee® vibration device

Buzzy Bee® extraoral vibration device DEVICE

Buzzy Bee® extraoral vibration device

The Buzzy Bee® vibration device first on the left side, then the DentalVibe vibration device; The Buzzy Bee® vibration device first on the right side then the DentalVibe vibration device; The DentalVibe vibration device first on the left side then the Buzzy Bee® vibration device; The DentalVibe vibration device first on the right side then the Buzzy Bee® vibration device

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children
• Non-anxious
• cooperative
• Aged six to 12
• No previous dental history or experience.
• Who required non-urgent dental treatment involving at least one pair of contralateral maxillary molars needing buccal infiltration anesthesia

You may not qualify if:

• Children requiring urgent dental treatment
• Those with active infections at the injection site
• Non-Arabic speakers
• Children with high anxiety scores in the ACDAS
• Those who were uncooperative during the screening appointment

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University

Jeddah, Saudi Arabia

Location

MeSH Terms

Conditions

Pain; Personal Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Sara Bagher, Associate Professor

CONTACT

00966547433525; sbagher@kau.edu.sa

Shahad Abudawood, Assistant Professor

CONTACT

00966503611195; sabudawood@kau.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Subjects will be divided into four groups. Those who first received maxillary buccal infiltration with the DentalVibe intraoral vibration device on the right side will be classified as group 1. Those who received it on the left side first will be classified as group 2. Meanwhile, subjects who received maxillary buccal infiltration with the Buzzy Bee® extraoral vibration device on the right side first will be classified as group 3, and those who received it on the left side first will be classified as group 4.

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: February 3, 2026
• Study Start: February 1, 2026
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)