NCT07705009

Brief Summary

Dental impressions are used to create a record of a person's teeth and oral structures. Conventional impressions are made using impression material placed in a tray, whereas digital impressions are obtained using an intraoral scanner. This randomized clinical trial compared conventional alginate impressions with digital intraoral scanning using the TRIOS 3 and Medit i700 scanners among dental students aged 18 to 24 years. Participants were randomly assigned to one of the three impression techniques. Each participant underwent recording of both the upper and lower dental arches using the assigned technique. The study primarily compared the chairside time required for each technique and the participants' experience immediately after the procedure. Comfort, nausea, breathing, pain, dry-mouth sensation, perceived procedure speed, overall satisfaction, and preference for conventional or digital impressions were also evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

July 10, 2026

Last Update Submit

July 10, 2026

Conditions

Keywords

Intraoral ScanningDigital Dental ImpressionAlginate ImpressionProcedure TimePatient ComfortDental Students

Outcome Measures

Primary Outcomes (2)

  • Total Chairside Procedure Time

    Total chairside procedure time was measured in seconds using a digital stopwatch and calculated as the sum of the recorded procedural stages. For the conventional alginate group, the stages included maxillary mixing, maxillary impression taking, mandibular mixing, and mandibular impression taking. For the digital groups, the stages included patient and case information entry, maxillary scanning, and mandibular scanning. Bite-registration time was excluded from the total procedure time because there was no equivalent stage in the conventional alginate workflow.

    During the assigned impression procedure at the single study visit

  • Patient-Reported Overall Comfort During the Impression Procedure

    Overall comfort during the assigned impression procedure was assessed immediately after the procedure using a 0-to-100 visual analogue scale. Higher scores indicated greater comfort.

    Immediately after completion of the assigned impression procedure

Study Arms (3)

Conventional Alginate Impression

ACTIVE COMPARATOR

Participants underwent maxillary and mandibular conventional impressions using alginate impression material and stock trays according to the manufacturer's instructions.

Procedure: Conventional Alginate Impression

TRIOS 3 Intraoral Scanning

EXPERIMENTAL

Participants underwent full-arch maxillary and mandibular digital impressions and bite registration using the TRIOS 3 intraoral scanner according to the manufacturer's recommended scanning protocol.

Procedure: TRIOS 3 Intraoral Scanner

Medit i700 Intraoral Scanning

EXPERIMENTAL

Participants underwent full-arch maxillary and mandibular digital impressions and bite registration using the Medit i700 intraoral scanner according to the manufacturer's recommended scanning protocol.

Procedure: Medit i700 Intraoral Scanner

Interventions

Maxillary and mandibular conventional impressions were obtained using Tropical alginate impression material and stock trays. The alginate was mixed, placed in the impression tray, and used according to the manufacturer's instructions.

Conventional Alginate Impression

Maxillary and mandibular full-arch digital impressions were obtained using the TRIOS 3 intraoral scanner according to the manufacturer's recommended scanning protocol. A bite-registration scan was also obtained.

TRIOS 3 Intraoral Scanning

Maxillary and mandibular full-arch digital impressions were obtained using the Medit i700 intraoral scanner according to the manufacturer's recommended scanning protocol. A bite-registration scan was also obtained.

Medit i700 Intraoral Scanning

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Undergraduate dental students at the University of Medicine and Pharmacy, Hue University.
  • Aged 18 to 24 years.
  • Willing to undergo one maxillary and one mandibular dental impression using the assigned technique.
  • Willing and able to complete the study questionnaire.
  • Provided written informed consent.

You may not qualify if:

  • Currently undergoing orthodontic treatment.
  • Presence of a systemic disease or acute condition that limited the ability to cooperate or increased the risk of discomfort during impression taking or intraoral scanning, including an acute respiratory disorder or frequent vomiting.
  • Limited mouth opening or an oral and maxillofacial condition that prevented correct impression-tray seating or scanner-tip placement according to the study protocol.
  • A maxillofacial abnormality that markedly affected the procedure or caused significant recording distortion.
  • An excessive gag reflex that prevented completion of the assigned procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Odonto-Stomatology, University of Medicine and Pharmacy, Hue University

Huế, 530000, Vietnam

Location

Related Publications (1)

  • Burzynski JA, Firestone AR, Beck FM, Fields HW Jr, Deguchi T. Comparison of digital intraoral scanners and alginate impressions: Time and patient satisfaction. Am J Orthod Dentofacial Orthop. 2018 Apr;153(4):534-541. doi: 10.1016/j.ajodo.2017.08.017.

Study Officials

  • Van Nhat Thang Le, DDS PhD

    Faculty of Odonto-Stomatology, University of Medicine and Pharmacy, Hue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 10, 2026

First Posted

July 15, 2026

Study Start

May 1, 2025

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

July 15, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations