- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07705009
Intraoral Scanning Versus Alginate Impressions in Dental Students
Procedure Time and Patient Comfort of Intraoral Scanning Versus Alginate Impressions Among Dental Students: A Randomized Clinical Trial
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Huế, Vietnam, 530000
- Faculty of Odonto-Stomatology, University of Medicine and Pharmacy, Hue University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Conventional Alginate Impression
Participants underwent maxillary and mandibular conventional impressions using alginate impression material and stock trays according to the manufacturer's instructions.
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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.
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Experimental: TRIOS 3 Intraoral Scanning
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.
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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.
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Experimental: Medit i700 Intraoral Scanning
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Total Chairside Procedure Time
Time Frame: During the assigned impression procedure at the single study visit
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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.
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During the assigned impression procedure at the single study visit
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Patient-Reported Overall Comfort During the Impression Procedure
Time Frame: Immediately after completion of the assigned impression procedure
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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.
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Immediately after completion of the assigned impression procedure
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Collaborators and Investigators
Investigators
- Principal Investigator: Van Nhat Thang Le, DDS PhD, Faculty of Odonto-Stomatology, University of Medicine and Pharmacy, Hue University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H2025/074
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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