Digital Versus Conventional Impression on Discomfort and Dental Anxiety Among Preschoolers
Effectiveness of Digital Versus Conventional Impression on Discomfort and Dental Anxiety in Preschool Children (A Randomized Controlled Clinical Trial)
Background: Taking alginate impressions for preschoolers is challenging and might be disturbing for them. Therefore, intraoral scanners are suggested as a better alternative to the conventional alginate impression.
Objectives: The present study aims to evaluate and compare the level of patients' discomfort, dental anxiety, gag reflex, behavior and time required for taking alginate impressions with that of intraoral scanning.
Materials and methods: The study will be a randomized, controlled clinical trial, parallel design. A total of 666 pediatric dental patients aged from 4-6 years will be selected from the outpatient clinic of the of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University. Participants will be allocated into 2 groups. Children in the first group will receive digital impressions by an intraoral scanner, while those of the second group will receive conventional alginate impressions. Patients' discomfort will be evaluated by a modified VAS index supported with emojis. Dental anxiety will be evaluated using Facial Image Scale (FIS). Gag reflex will be assessed by Gag Severity Index (GSI). Child's behavior towards the impression technique in the 2 groups will be evaluated using Venham's Behavior rating scale. Time taken to complete the procedures will be recorded using a digital stopwatch.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Arwa Ghoneim, BDS
- Phone Number: 01204666655
- Email: arwaghoneim1992@gmail.com
Study Locations
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-
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Alexandria, Egypt
- Recruiting
- Alexandria Faculty of Dentistry
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Contact:
- Arwa Ghoneim, BDS
- Phone Number: 01204666655
- Email: arwaghoneim1992@gmail.com
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Principal Investigator:
- Arwa Gohneim, BDS
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children with scores of 3 or 4 during preoperative assessments according to the Frankl Behavioral Rating Scale.
- No previous dental experience.
- Patient's parents signed an informed consent before participating in the trial.
Exclusion Criteria:
- Any physical or mental disability, or psychological problems.
- Children with temporomandibular joint or periodontal discomfort
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Digital dental Impression
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Active Comparator: Conventional dental impression
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Conventional impressions of both arches will be made according to the manufacturer's instructions, using steel impression trays and alginate
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in child discomfort
Time Frame: intraoperative
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Children's discomfort will be evaluated using a 100-mm modified VAS index supported with facial emojis.
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intraoperative
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Change in dental anxiety
Time Frame: intraoperative
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Dental anxiety will be recorded using the Facial Image Scale (FIS) Children will be asked to indicate which of the faces they feel most like at that moment, it is a 'state' measure of anxiety that provides an immediate reflection of how the child is feeling.
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intraoperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gag reflex
Time Frame: post procedure
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After taking the impressions, child's gag reflex will be assessed.
Gag sensitivity is ranked on a scale from 1 (least severe) to 5 (most severe) using the Gagging Severity Index (GSI)
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post procedure
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Assessment of level of child cooperation
Time Frame: intraoperative
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Venham's Behavior rating scale classifies the child's behavior into 6 categories with scores ranging from 0 to 5. A score of 0 means total cooperation and a score of 5 refers to complete absence of compliance and cooperation and the requirement of physical restraint
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intraoperative
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procedure time
Time Frame: intraoperative
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Time taken from scanning and taking impression for the lower and upper jaws to the final bite registeration.
Time will be recorded in minutes
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intraoperative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0863-2/2024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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