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

NCT07377890 | Recruiting

• 1 other identifier: MBRU IRB-2024-107
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Edentulism; Complete Dentures; Digital Impression Accuracy; Dental Impression Techniques

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• The difference (mm) in mean RMS trueness between the maxillary and mandibular arches is measured.

  1 week

• Difference (mm) in mean RMS trueness between static (attached) and dynamic (mobile) regions.

  1 week

Other Outcomes (1)

• Difference (mm) in mean RMS precision between static (attached) and dynamic (mobile) regions.

  1 week

Study Arms (1)

Edentulous patients

EXPERIMENTAL

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

Interventions

Digital and conventional impressions PROCEDURE

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.

Also known as: intra-oral scanning, border-molded impression

Edentulous patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Dubai Dental Hospital

Dubai, 505055, United Arab Emirates

RECRUITING

Related Publications (3)

• 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.

  PMID: 33289648 BACKGROUND

• 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.

  PMID: 35997079 BACKGROUND

• 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.

  PMID: 37699190 BACKGROUND

Related Links

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 30, 2026
• Study Start: October 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

AE (1)