Accuracy of Digital vs Conventional Denture Impressions: An In Vivo Study

Accuracy of Intraorally Scanned Denture Impressions Compared to Conventional Border-Molded Impressions: An In Vivo Study

The goal of this clinical trial is to compare the accuracy of two denture impression techniques, digital intraoral scanning and conventional border-molded impressions, in adults who have lost all their teeth (fully edentulous patients).

The main questions it aims to answer are:

Is a digital intraoral scan as accurate as a conventional impression for capturing the shape of the mouth, including movable gum areas? Are repeated digital scans consistent (precise) when taken multiple times on the same patient? Researchers will compare digital impressions taken with an intraoral scanner to conventional impressions made with custom trays and border molding to see if digital scans can match the accuracy of the traditional "gold standard" method.

Participants will:

Attend Dubai Dental Hospital for two study visits. Have their mouth scanned three times using a digital intraoral scanner. Have a conventional impression taken using a custom tray and high-accuracy material after border molding.

Provide informed consent and allow their impression data to be analyzed for accuracy.

Study Overview

• Status: Recruiting
• Conditions: Dental Impression Techniques; Edentulism; Complete Dentures; Digital Impression Accuracy
• Intervention / Treatment: Procedure: Digital and conventional impressions

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Arab Emirates
  • Dubai, United Arab Emirates, 505055
    • Recruiting
    • Dubai Dental Hospital
    • Contact: Khadeeja Abdul Rahiman; Phone Number: 00971050953219; Email: khadeeja.abdul@dubaihealth.ae

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients attending DDH for complete dental prosthesis.
• Fully edentulous patients
• All alveolar ridge classifications of Cawood and Howell 1988 (Cawood and Howell, 1988)
• Above 18 years old
• Arabic and English-speaking patients
• Good physical health (ASA class 1 or 2)
• Willing to provide informed consent.

Exclusion Criteria:

• Dentate patients
• Implant-attachment-supported complete denture.
• Patients un-willing to participate (non-consented patients)
• Patients with severe gag reflex
• Patients who are mentally unstable, drug users or alcoholics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Edentulous patients; Arm Description: Participants will first receive digital intraoral scanning of their fully edentulous upper and/or lower jaw using the TRIOS 5 intraoral scanner (3Shape). The scanning process follows a structured sequence to capture the entire arch, including the palate and ridge slopes. Each arch will be scanned three times during the same visit to assess precision (consistency of repeated scans). Then the same participants will also undergo a conventional impression procedure using a custom tray and border molding technique.

Procedure: Digital and conventional impressions; Participants will first receive digital intraoral scanning of their fully edentulous upper and/or lower jaw using the TRIOS 5 intraoral scanner (3Shape). The scanning process follows a structured sequence to capture the entire arch, including the palate and ridge slopes. Each arch will be scanned three times during the same visit to assess precision (consistency of repeated scans). Then the same participants will also undergo a conventional impression procedure using a custom tray and border molding technique.; Other Names: intra-oral scanning; border-molded impression

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trueness of Digital Impressions: Mean root mean square Deviation (mm) between intraoral scanner (IOS) digital impressions and conventional impression scans-per arch	Trueness will be checked by looking at the Root Mean Square (RMS) deviation (mm) after superimposing the IOS Standard Tessellation Language (STL) over the conventional impression scan STL (reference) using Geomagic Control X. The primary metric is the participant-level mean RMS over the full arch surface (edentulous maxilla and mandible analyzed separately). Lower RMS indicates greater trueness (higher accuracy). Region-specific RMS (static vs. dynamic tissues) will be recorded as prespecified analyses (see secondary outcomes). Alignment: Initial + best-fit alignment; conventional scan = reference file. Reporting (participant level): Mean RMS (mm) per arch. Reporting (study level): Mean [Standard Deviation (SD)], RMS per arch; 95% CI; distribution plots as applicable. Unit of Measure: millimeters (mm), RMS deviation Regions analyzed: Static (palatal rugae, ridge slopes, crest) and dynamic (labial, buccal, lingual sulci, hamular notch, posterior palatal seal).	1 week
Precision of Digital Impressions: Within-Subject Mean Pairwise RMS Deviation (mm) Across Three IOS Scans (Precision)-per Arch	Precision will be quantified by pairwise deviation analysis between three repeated IOS scans per arch taken on the same day. STL files will be aligned (Initial + Best-Fit ICP) in Geomagic Control X. For each arch, the following pairs will be analyzed: (Scan1-Scan2), (Scan1-Scan3), and (Scan2-Scan3). Each pair will be aligned in both directions (each file alternately as reference), and all RMS values will be averaged to yield the participant-level mean pairwise RMS (mm) for that arch. Lower RMS indicates greater precision (repeatability). Reporting (participant level): Mean of all pairwise RMS values per arch. Reporting (study level): Mean (SD) RMS per arch; 95% CI; distribution plots as applicable. Unit of Measure: millimeters (mm), RMS deviation	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference (mm) in mean RMS trueness between the maxillary and mandibular arches is measured.	Compute mean RMS trueness (mm) per arch (as defined in Primary Outcome 1). The between-arch difference will be calculated as maxilla minus mandible (mm). Positive values indicate higher RMS (worse trueness) in the maxilla. Reporting (study level): Mean (SD) difference; 95% CI; paired analysis. Unit of Measure: millimeters (mm), RMS deviation	1 week
Difference (mm) in mean RMS trueness between static (attached) and dynamic (mobile) regions.	Within each arch, participant-level trueness RMS (mm) will be computed separately for prespecified static regions (palatal rugae; buccal and palatal/lingual slopes; ridge crest) and dynamic regions (labial, buccal, and lingual sulci; hamular notch; posterior palatal seal). The regional difference will be calculated as Dynamic minus Static (mm). Positive values indicate higher RMS (worse trueness) in mobile tissues. Reporting (study level): Mean (SD) difference; 95% CI; by arch as applicable. Unit of Measure: millimeters (mm), RMS deviation	1 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference (mm) in mean RMS precision between static (attached) and dynamic (mobile) regions.	Using the precision pipeline (Primary Outcome 2), compute regional mean pairwise RMS (mm) for static and dynamic regions per arch and participant, then calculate Dynamic minus Static (mm). Positive values indicate higher RMS (worse precision) in mobile tissues. Reporting (study level): Mean (SD) difference; 95% CI; by arch as applicable. Unit of Measure: millimeters (mm), RMS deviation	1 week

Collaborators and Investigators

• Sponsor: Mohammed Bin Rashid University of Medicine and Health Sciences

Publications and helpful links

General Publications

• Zarone F, Ruggiero G, Ferrari M, Mangano F, Joda T, Sorrentino R. Comparison of different intraoral scanning techniques on the completely edentulous maxilla: An in vitro 3-dimensional comparative analysis. J Prosthet Dent. 2020 Dec;124(6):762.e1-762.e8. doi: 10.1016/j.prosdent.2020.07.017. Epub 2020 Oct 24.
• Al Hamad KQ, Al-Kaff FT. Trueness of intraoral scanning of edentulous arches: A comparative clinical study. J Prosthodont. 2023 Jan;32(1):26-31. doi: 10.1111/jopr.13597. Epub 2022 Sep 6.
• Casucci A, Mazzitelli C, Tsiplakis V, D'Arienzo LF, Breschi L, Ferrari M. Digital Impressions in Edentulous Patients: A Systematic Review for Clinical Evidence. Int J Prosthodont. 2023 Sep 12;36(4):486-497. doi: 10.11607/ijp.7483.

Helpful Links

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Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MBRU IRB-2024-107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No