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A Novel Approach in Reducing Dental Pain and Anxiety of Pediatric Patient During Local Anesthesia.

NCT04585061 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-11-11

No results posted yet for this study

Summary

The aim of this study is to determine the efficacy of sweet in compare to virtual reality (VR) device in reducing injection pain and anxiety associated with local anesthesia in pediatric dental patients.

The clinical trial is a randomized split-mouth assignment. Included patients are 5 - 12 years old requiring local anesthetic infiltration with conventional syringe (CS) for conservative treatment of two primary maxillary molars bilaterally.

Eligible patients undergo two single-visit treatments after CFSS-DS measurement before each, whereas sweet is allocated to first local anesthesia procedure and VR is allocated to second local anesthesia procedure. Primary outcome measure will be pain felt during injection, reported by patient on visual analogue scale (VAS). Secondary outcome measures: self-reported anxiety during injection on FIS; pain-related behavior according to FLACC scale; heart-rate dynamics; patient preference to local anesthesia method - CS+sweet or CS+VR.

Conditions

Interventions

DRUG

Lidocaine Hydrochloride

1.8ml of 2%Lidocaine HCl to be administered via a 21mm needle

DEVICE

Virtual reality device (Harga Miniso Vr Glass 3d terbaru)

Virtual reality device (Harga Miniso Vr Glass 3d terbaru) is placed on the face of the patient, playing a video of Tom and Jerry cartoon. Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized

DIETARY_SUPPLEMENT

Xylitol

Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized while xylitol tablet putted under tongue

Sponsors & Collaborators

  • Riyadh Elm University

    lead OTHER

Principal Investigators

  • AbdulRahman Alasmari, Resident · Riyadh Elm University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2021-02-18
Completion
2021-02-18

Countries

  • Saudi Arabia

Study Locations

More Related Trials

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 NCT04585061 on ClinicalTrials.gov