Children's Preferences on Digital and Conventional Impression Techniques

April 29, 2025 updated by: Uşak University

Digital and Conventional Impression Techniques: What Influences Children's Preferences?

The goal of this crossover study is to compare children's perceptions and preferences regarding digital and conventional impression techniques in the 5- to 11-year-old age group. The main questions it aims to answer are

  • Which impression methods do kids prefer?
  • What influences kids' perception of impression methods?

Dental impressions will be obtained using both the conventional alginate impression (CAI) (Cavex ColorChange; Cavex Holland BV, Haarlem, the Netherlands) and digital intraoral scanning procedure (DIS) (3Shape TRIOS Color, 3Shape, Copenhagen, Denmark). After each procedure, patients will score their perceptions using a Modified Impression Perception Test, a 5-point Likert scale, for gag reflex, queasiness, difficulty breathing, uncomfortable feeling, pain perception, chairside time, and stress levels. Dental anxiety will be assessed using the Visual Anxiety Scale (1-10). Children will also be asked about their preferences and reasons in one or two sentences. Content analysis will be performed on answers to open-ended questions. Statistical analysis will be done using Fisher's Exact test.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Usak, Turkey, 64200
        • Usak University School of Dentistry, Department of Pediatric Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • No prior exposure to either digital or conventional impression techniques
  • Absence of temporomandibular joint disorders and periodontal disease
  • Cleft lip and/or palate, or other significant craniofacial anomalies
  • No current use of psychiatric or neuropathic medications

Exclusion Criteria:

  • Individuals with a known history of dental anxiety or a pronounced gag reflex

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: children aged between 5-11 who need space maintainer or orthodontic treatments
Device: digital intraoral scanner
Alginate impressions were obtained with an irreversible hydrocolloid impression material (Cavex Impressional; Cavex Holland, Haarlem, The Netherlands) and standard plastic trays. For each impression, the time required to mix the material and complete a full-mouth (maxillary and mandibular arches) impression was recorded.
Device: Alginate Impression
Alginate impressions were obtained with an irreversible hydrocolloid impression material (Cavex Impressional; Cavex Holland, Haarlem, The Netherlands) and standard plastic trays. For each impression, the time required to mix the material and complete a full-mouth (maxillary and mandibular arches) impression was recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Children Perception test
Time Frame: one year
After the each impression proscedure, to evaluate children's perspectives on the impression techniques, the perception questionnaire used in Burhardt's study was adapted for this research.5 The questionnaire was translated into Turkish to ensure cultural and linguistic appropriateness. The translated version underwent content validation through expert review to ensure its relevance and appropriateness for the target population. The perception questionnaire used in this study aimed to measure gag reflex, queasiness, difficulty to breathe, discomfort, time perception, stress, pain. Accordingly, 8 questions with 5-point Likert scale responses ranging from "strongly agree" to "strongly disagree" were included (Figure-1). Additionally, the Visual Anxiety Scale (VAS) was employed to measure overall discomfort. For the VAS results, children were asked to score their perceived discomfort on a scale from 0 (no discomfort) to 10 (extreme discomfort).
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Responses to open-ended questions
Time Frame: one year
After completing both of the impression proscedure, children were asked two questions regarding their preference: one closed-ended question "Which method did you prefer?" and one open-ended follow-up question "Why did you prefer this method?". The latter was used for thematic content analysis.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uşak University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2023

Primary Completion (Actual)

June 15, 2024

Study Completion (Actual)

October 15, 2024

Study Registration Dates

First Submitted

April 21, 2025

First Submitted That Met QC Criteria

April 21, 2025

First Posted (Actual)

April 29, 2025

Study Record Updates

Last Update Posted (Actual)

May 2, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 333-333-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data includes personel data of the participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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