The Acceptability of Digital Impression Compared to Conventional Technique in Children

NCT07002138 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-06-03

No results posted yet for this study

Summary

This randomized crossover clinical trial aims to evaluate the acceptability of digital intraoral impressions compared to conventional alginate impressions in children aged 6 to 11 years. The study will assess patient comfort, anxiety, time efficiency, and preference using validated tools. A total of 40 children who require dental impressions for orthodontic or prosthetic treatment will be enrolled and randomly assigned to receive both impression techniques in alternating order, with a washout period of 14-21 days between sessions. Data collection includes Visual Analog Scale (VAS) scores for comfort and gag reflex, Venham's Clinical Anxiety Scale for anxiety assessment, and comparative questionnaires for both patients and parents. The study aims to determine whether digital impressions offer a more acceptable and less distressing alternative for pediatric patients in clinical dental settings.

Conditions

  • Dental Anxiety
  • Gagging
  • Dental Impression Techniques
  • Pediatric Dentistry

Interventions

DEVICE

Digital Dental Impression

Digital dental impressions were performed using the Medit i700 intraoral scanner (Medit, Seoul, South Korea). The scanner utilizes 3D-in-motion video technology with UV-C and LED light sources and adaptive anti-fogging. Scans were taken of both upper and lower arches following manufacturer-recommended protocols. Two tip sizes were used (normal and small), and scanning included occlusal, lingual, and buccal surfaces. Moisture control was maintained with cheek retractors and saliva ejectors. Impression time was recorded using a chronometer. This procedure was used to evaluate patient comfort, anxiety, and preference.

PROCEDURE

Conventional Dental Impression

Conventional impressions were taken using extra-fast setting flavored alginate (Hydrogum 5, Zhermack SpA, Italy) for both upper and lower arches. The impression material was manually mixed according to the manufacturer's instructions and applied using standard perforated plastic trays suitable for pediatric arches. Children were seated upright, and the impression sequence followed lower arch first, then upper arch. Comfort was evaluated using VAS scores and anxiety using the Venham Clinical Anxiety Scale (VCAS). The procedure was timed with a chronometer.

Sponsors & Collaborators

  • Beirut Arab University

    lead OTHER

Principal Investigators

  • Associate Professor Ahmad Tarabaih, Associate Professor Ahmad · Beirut Arab University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-05-17
Completion
2024-05-17

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07002138 on ClinicalTrials.gov