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Clinical Trials/NCT06122883
NCT06122883
Completed
Not Applicable

Official Title Evaluating the Effect of Dentist's Attire on Children's Acceptance of Dental Treatment Including Local Anesthesia

Damascus University1 site in 1 country120 target enrollmentJanuary 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Behavior, Child
Sponsor
Damascus University
Enrollment
120
Locations
1
Primary Endpoint
Pain levels
Status
Completed
Last Updated
last year

Overview

Brief Summary

The aim of this study is to evaluate the effect of friendly attire on dental anxiety among children visiting dental office in comparison with conventional attire. All of the children who will be experienced maxillary dental anesthesia with/without distraction will be assessed by using a combination of measures: Wong-Baker faces and the Children's Fear Scale (self-report), heart pulse rate, and behavior (using Anxiety levels using Face - Legs - Activity - Cry - Consolability "FLACC" scale "external evaluator") Acceptance will be measured using a two-point Likert scale.

Detailed Description

This study will evaluate the effect of dental attire on children's acceptance of different dental treatments that include dental anesthesia. pain and anxiety will be evaluated during buccal and palatal infiltration using five behavioral scales, Wong-Baker pain scale, Children's Fear Scale and Children's Anxiety Questionnaire (self-report), pulse rate (physiological) and behavior (using FLACC behavior rating scale "external evaluator". Heart pulse rate measurement will be recorded firstly when the patient is seated comfortably in the reception area, on dental chair prior to the injection, and finally after the procedure is done and the child patients will be asked to choose a face that describe their status from one of both Wong Baker faces scale, Children's Fear Scale and Children's Anxiety Questionnaire. Body responses of all child patients will be recorded during the whole procedure and then will be evaluated by an external evaluator to determine the children behavioral score according to FLACC scale.

Registry
clinicaltrials.gov
Start Date
January 15, 2023
End Date
May 25, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age between 6 and 10 years.
  • No previous dental experience.
  • Definitely positive or positive according to Frank scale.
  • Need of maxillary anesthesia for any dental treatment.

Exclusion Criteria

  • Previous dental experience
  • Systematic or mental disorders.
  • Definitely negative or negative according to Frankel scale

Outcomes

Primary Outcomes

Pain levels

Time Frame: 5 minutes following the dental local anesthesia.

Pain levels will be measured by using a self-reported simplified Wong-Baker faces pain scale: 0 no Hurt - 1 Hurts little Bit - 2 Hurts little More - 3 Hurts Even More - 4 Hurts Whole Lot - 5 Hurts Worst

Anxiety levels

Time Frame: 5 minutes following the meeting with the dentist in the reception area, and 5 minutes after the patient is seated comfortably on the dental chair

This will be evaluated using Children's Fear Scale (0 indicating 'no anxiety' and 4 indicating 'extreme anxiety') and Children Anxiety Questionnaire (self-report) (4 indicating 'no anxiety' and 16 indicating 'extreme anxiety').

Pulse rate

Time Frame: (1) five minutes after the patient is seated comfortably in the reception area, (2) five minutes after the patient is seated comfortably on the dental chair, (3) five minutes following the injection of the anesthetic drug

Pulse rate (the number of times your heart beats each minute bpm will be evaluated using Finger Pulse Oximeter.

Study Sites (1)

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