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Efficacy of External Cold and a Vibrating Device in Reducing Discomfort of Dental Injections in Children

NCT02675387 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-02-05

No results posted yet for this study

Summary

Children in their seventh year of life (age range of 6 to 7 years) will be included in the study. All children included in the study would have to classified according to the Wright behavior classification as potentially co-operative and rated as per the Frankl behavior rating scale as positive (++) Group A and negative (-) Group B . All children included must have had no prior experience of dental anesthesia and must have at least one tooth requiring restorative procedure on either side of the maxillary arch. Intervention Description

1. Regular Anesthesia All the subjects received local anesthesia injection in maxillary arch as is commonly practiced in dental clinics. Information obtained before assignment of intervention or standard care included age, gender, type of injection given alongside the vibration device will be recorded beforehand. During the delivery of anesthesia for all the groups, anticipated and actual pain will be recorded to show the impact of anxiety on the experience of participants. During the entire process, all participants will use standard needles with confirmed specification to control for any potential confounders
2. Buzzy® The use of the external cold and a vibrating Device will follow the manufacturer's recommendations to ensure that normal clinical scenario is created.

Conditions

Interventions

DEVICE

Buzzy

Two minute application of a hand held vibrating device (Buzzy, MMJ labs, Atlanta GA, USA) before the administration of anesthesia

DRUG

2%Lidocaine

1.8ml of 2%Lidocaine HCl to be administered via a 21mm needle (30 Guage)

Sponsors & Collaborators

  • Riyadh Colleges of Dentistry and Pharmacy

    lead OTHER

Principal Investigators

  • Sharat C Pani · Riyadh Colleges of Dentistry and Pharmacy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-03-31
Completion
2017-06-30

Countries

  • Saudi Arabia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02675387 on ClinicalTrials.gov