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Effect of Vibrasthetic Device on Pain Reduction During Local Anesthesia in Pediatric Patients

NCT ID: NCT07306650

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-26

Study Completion Date

2026-06-30

Brief Summary

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The goal of this clinical trial is to test if children aged between 6 and 14 years who are receiving a dental injection will feel less pain by using a vibration device applied to the injection site during the injection compared to vibrating the lip using only the researcher's hands without using the vibration device. It will also test if this device makes them feel less anxious during the injection. The main question it aims to answer is:

Does using the Vibrasthetic device make dental injections more comfortable for children? Researchers will compare the effect of using this vibration device versus using their hands for manual vibration of the lip in the same child.

Participants will:

* Experience one method of vibration during their visit to the dentist (either the vibration device or manual vibration).
* then after 2 weeks they will go to the same dentist again and experience the other method of vibration.
* Receive the dental treatment they need in both visits. Participants will be asked to rate the pain they felt after the injection. This will be done by the participants choosing one of 6 pictures we will show them. Each picture explains the level of the pain they felt, and each picture has a score. We will score the pain the participants felt by looking at which picture they chose to describe their pain from the injection.

Detailed Description

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Each participant will start their dental appointment by them sitting on a chair beside the dental chair and having their heart rate recorded by a pulse oximeter for baseline comfort level. They will be randomly assigned to either receive the vibration using the Vibrasthetic vibration device or by the dentist researcher manually vibrating the participant's lip during the injection. Topical anesthesia will be applied on the injection site and then they will receive the dental injection along with experiencing vibration in the area of the dental injection administered. Immediately after the injection, the participant will rate the pain intensity felt during the injection using validated Pain Scale (Wong-Baker). During the injection, a separate researcher, called the monitor, will monitor the participant's pain using the FLACC scale (Face, Legs, Activity, Cry, Consolability). Also, the monitor will record the participant's behavior using the Frankl scale, after which the participant will receiver their needed dental treatment. In the following visit, the participant will receive the other vibration method before their dental treatment with the recording of the same metrics by the researchers.

Conditions

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Healthy Behavior Management

Keywords

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Vibrasthetic Vibration child behavior management local anesthesia pediatric dentistry

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Device

This group will experience receiving a dental injection while the operator uses a vibrating device (Vibrasthetic) to vibrate the injection site.

Group Type EXPERIMENTAL

Vibrating device

Intervention Type DEVICE

Battery powered, no need to replace vibrating head of the unit (only a plastic barrier is required to cover the device), not investigated before.

Manual

Our study is a crossover study, so the participants will receive the dental injection while the operator manually vibrates their lip by holding the lip between their forefinger and thumb (control). The partcipants will be randomized, so phase I for the participants may be either the device or manual, and phase II will be the other method of vibration not used in phase I.

Group Type ACTIVE_COMPARATOR

Manual vibration

Intervention Type PROCEDURE

The operator will hold the participant's lip between their forefinger and thumb to manually vibrate the lip and hence vibrating the injection site.

Interventions

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Vibrating device

Battery powered, no need to replace vibrating head of the unit (only a plastic barrier is required to cover the device), not investigated before.

Intervention Type DEVICE

Manual vibration

The operator will hold the participant's lip between their forefinger and thumb to manually vibrate the lip and hence vibrating the injection site.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Children aged 6-14 years
* who have previously received local anesthesia
* and whose behavior, according to the Frankl scale, was positive or definitely positive
* and the absence of systemic diseases or known allergies to local anesthetic agents

Exclusion Criteria

* Uncooperative children
* Children with special healthcare needs
* Children with conditions affecting pain perception
Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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King Abdulaziz University

OTHER

Sponsor Role lead

Responsible Party

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Mariam Aldajani

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mariam B Aldajani

Role: PRINCIPAL_INVESTIGATOR

King Abdulaziz University

Locations

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King Abdulaziz University Dental Hospital

Jeddah, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Central Contacts

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Mariam B Aldajani, Master of Dental Science (MDS)

Role: CONTACT

Phone: 00966-567808848

Email: [email protected]

Ghalia Y Bhadila

Role: CONTACT

Phone: 00966-503637670

Email: [email protected]

Facility Contacts

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Mariam B Aldajani

Role: primary

Role: backup

References

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Ching D, Finkelman M, Loo CY. Effect of the DentalVibe injection system on pain during local anesthesia injections in adolescent patients. Pediatr Dent. 2014 Jan-Feb;36(1):51-5.

Reference Type BACKGROUND
PMID: 24717710 (View on PubMed)

Oliveira MA, Bendo CB, Ferreira MC, Paiva SM, Vale MP, Serra-Negra JM. Association between childhood dental experiences and dental fear among dental, psychology and mathematics undergraduates in Brazil. Int J Environ Res Public Health. 2012 Dec 17;9(12):4676-87. doi: 10.3390/ijerph9124676.

Reference Type BACKGROUND
PMID: 23247225 (View on PubMed)

Kadam, N. S., Hegde, A. M., & Sharma, A. (2024). Comparative evaluation of anxiety levels in children using distraction techniques: An assessment with Venham Picture Test and pulse oximeter. Journal of Scientific Dentistry, 12(2), 95-101

Reference Type BACKGROUND

Other Identifiers

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96-06-25

Identifier Type: -

Identifier Source: org_study_id