The Acceptability of Digital Impression Compared to Conventional Technique in Children

NCT07002138 | Completed

• 1 other identifier: 2023-H-0139-D-M-0578
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

intraoral scanners; pediatric dentistry; gag reflex; alginate impressions; children preference; parents preference

Outcome Measures

Primary Outcomes (2)

• Comparison of patient comfort during digital and conventional methods

  Child comfort level during each impression was recorded using the Visual Analogue Scale (VAS), a 6-point questionnaire 10 cm VAS where "10" represented maximum complaint whereas the value "0" meant no discomfort and better outcome. Scores were documented by the operator and analyzed across impression type, cooperation level, and gag reflex severity.

  Assessed immediately following each impression procedure during the same clinical visit

• Duration of digital versus conventional dental impressions

  Time (in seconds) required to complete each impression was measured using a chronometer. Timing included preparation and execution phases. Durations for digital (Medit i700) and conventional (Hydrogum 5) impressions were compared across age groups, gag reflex severity, scanner tip size, and cooperation levels

  Assessed immediately following each impression procedure during the same clinical visit

Secondary Outcomes (3)

• Comparison of child anxiety levels during digital and conventional impressions

  Assessed immediately following each impression procedure during the same clinical visit.

• Comparison of patient and caregiver preferences for digital versus conventional impressions

  Assessed immediately after digital procedure during the same clinical visit.

• Comparison of operator perception of difficulty and applicability of digital versus conventional impressions

  Assessed immediately after both impressions were completed for each participant during the same clinical session.

Study Arms (2)

Sequence A: Conventional First, then Digital

EXPERIMENTAL

Participants in this group receive a conventional alginate impression first (Hydrogum 5, Zhermack), followed by a digital intraoral scan (medit i700) (after a 14-21 day washout period).

Device: Digital Dental Impression; Procedure: Conventional Dental Impression

Sequence B: Digital First, then Conventional

EXPERIMENTAL

Participants in this group receive a digital intraoral scan first (medit i700), followed by a conventional alginate impression (Hydrogum 5, Zhermack) after a 14-21 day washout period.

Device: Digital Dental Impression; Procedure: Conventional Dental Impression

Interventions

Digital Dental Impression DEVICE

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.

Also known as: Intraoral scan

Sequence A: Conventional First, then Digital; Sequence B: Digital First, then Conventional

Conventional Dental Impression PROCEDURE

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.

Also known as: Alginate impression

Sequence A: Conventional First, then Digital; Sequence B: Digital First, then Conventional

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6-11 years
• In need for the fabrication of fixed or removable appliance
• Having gagging problem based on the Classification of Gagging Problem scale starting from G1 to G5. (Saita et al., 2013) Where G1 is Normal Gagging: Normal gagging but not desensitized (controlled by the patient). The patient can withstand a full mouth examination with a dental mirror and a basic periodontal examination G2 is Mild gagging : Gagging when probe was used in a basic periodontal examination G3 is Moderate gagging: Gagging when examining molar teeth with a mirror G4 is Severe gagging: Gagging when examination of anterior teeth with a mirror G5 is Very severe gagging: Gagging at the moment when the dental mirror is inserted

You may not qualify if:

• Having a previous experience with any type of dental impressions.
• Having any systemic diseases or mental disorders.

Sponsors & Collaborators

• Beirut Arab University: lead

Study Sites (1)

The Pediatric Dental clinics of the Faculty of Dentistry at Beirut Arab University

Beirut, 11072809, Lebanon

Location

MeSH Terms

Conditions

Gagging

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Associate Professor Ahmad Tarabaih, Associate Professor Ahmad

  Beirut Arab University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 17, 2025
• First Posted: June 3, 2025
• Study Start: November 1, 2023
• Primary Completion: May 17, 2024
• Study Completion: May 17, 2024
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)