Children's Preferences on Digital and Conventional Impression Techniques

NCT06948617 | Completed

• 1 other identifier: 333-333-11
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Impressions

Keywords

dental impression; digital intraoral scanner; alginate; children

Outcome Measures

Primary Outcomes (1)

• Modified Children Perception test

  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 Outcomes (1)

• Responses to open-ended questions

  one year

Study Arms (1)

children aged between 5-11 who need space maintainer or orthodontic treatments

EXPERIMENTAL

Device: digital intraoral scanner; Device: Alginate Impression

Interventions

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.

children aged between 5-11 who need space maintainer or orthodontic treatments

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.

children aged between 5-11 who need space maintainer or orthodontic treatments

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Uşak University: lead

Study Sites (1)

Usak University School of Dentistry, Department of Pediatric Dentistry

Uşak, 64200, Turkey (Türkiye)

Location

Related Publications (1)

• Yilmaz H, Aydin MN. Digital versus conventional impression method in children: Comfort, preference and time. Int J Paediatr Dent. 2019 Nov;29(6):728-735. doi: 10.1111/ipd.12566. Epub 2019 Aug 13.

  PMID: 31348834 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 29, 2025
• Study Start: January 15, 2023
• Primary Completion: June 15, 2024
• Study Completion: October 15, 2024
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)