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OpenTrials
Completed

NCT Number: NCT06948617

Children's Preferences on Digital and Conventional Impression Techniques

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.

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Key information

Conditions

Age range

5 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Usak University School of Dentistry, Department of Pediatric Dentistry

Uşak, 64200, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

digital intraoral scanner

Device

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.

Alginate Impression

Device

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Uşak University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 29, 2025
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.