NCT03953001

Brief Summary

The study assesses the effect of a new vibration system on pain reduction during the injection of local anesthesia. Children undergoing dental treatment are allocated to two groups; one receiving the Buzz, a vibration system and another group receiving nothing. Pain during injection of local anesthetic is assessed using a validated tool in addition to assessment of child cooperation during treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 16, 2019

Completed
Last Updated

May 16, 2019

Status Verified

May 1, 2019

Enrollment Period

3 months

First QC Date

March 29, 2019

Last Update Submit

May 15, 2019

Conditions

Local AnaestheticDental Anxiety

Outcome Measures

Primary Outcomes (1)

  • Self Reported pain intensity: Visual analogue scale (VAS) of pain intensity

    Self reported pain intensity before the injection and directly after the injection. Each child scored pain intensity twice, one before the injection and one directly after the injection (0=no pain; 10=Very painful).

    Procedure (immediately after the administration of Dental anesthesia)

Secondary Outcomes (3)

  • Parents Perception for the child tolerance of pain; Observational Pain rating scale

    Procedure (immediately after the administration of Dental anesthesia.)

  • External observation for Facial and Physical expression. Using Sounds, Eyes, and Motor (SEM) scale (RANGE 0-9).

    Procedure (immediately during and after the administration of Dental anesthesia.)

  • Faces Legs Activity Cry Consolability (FLACC) Scale (RANGE 0-10)

    Procedure (immediately during and after the administration of Dental anesthesia.)

Study Arms (2)

Buzzy

EXPERIMENTAL

Buzzy was used during Maxillary anesthetic infiltration injection with 2%lidocaine with 1:50,000 epinephrine after topical application with 20% Benzocaine topical gel.

Device: Adminstration Technique using Buzzy external distractorDrug: 2% Lidocaine with 1:50,000 epinephrineDrug: Topical Anesthetic

Control

ACTIVE COMPARATOR

Maxillary anesthetic infiltration injection with 2%lidocaine with 1:50,000 epinephrine after topical application with 20% Benzocaine topical gel only.

Drug: 2% Lidocaine with 1:50,000 epinephrineDrug: Topical Anesthetic

Interventions

Adminstration Technique using Buzzy external distractorDEVICE

External application of Buzzy distractor during administration of dental anesthetic

Buzzy
2% Lidocaine with 1:50,000 epinephrineDRUG

Local Dental anesthetic infiltration

BuzzyControl
Topical AnestheticDRUG

20% Benzocaine gel was applied on the area of infiltration

BuzzyControl

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children 5-12 years of age.
  • Positive or definitely positive behavior on Frankl scale.6
  • Children receiving treatment on the dental chair.
  • Free from allergies to topical anesthetic used in the study.
  • Parental consent for child participation in the study.

You may not qualify if:

  • Those in need of treatment under general anesthesia will be excluded from the study.
  • Children with allergies from topical anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

imam adbulrahman Bin Faisal University- College of Dentistry

Dammam, 32412, Saudi Arabia

Location

Related Publications (1)

  • AlHareky M, AlHumaid J, Bedi S, El Tantawi M, AlGahtani M, AlYousef Y. Effect of a Vibration System on Pain Reduction during Injection of Dental Anesthesia in Children: A Randomized Clinical Trial. Int J Dent. 2021 Jan 30;2021:8896408. doi: 10.1155/2021/8896408. eCollection 2021.

    PMID: 33564311DERIVED

MeSH Terms

Interventions

LidocaineEpinephrineAnesthetics, Local

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsAnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • Jehan A AlHumaid, DSc

    imam Abdulrahman Bin Faisal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 29, 2019

First Posted

May 16, 2019

Study Start

January 1, 2018

Primary Completion

April 1, 2018

Study Completion

June 1, 2018

Last Updated

May 16, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)