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AzTrials

EdentulismNCT07377890

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

A study testing Digital and conventional impressions in people with Edentulism and Complete Dentures, run by Mohammed Bin Rashid University of Medicine and Health Sciences at 1 site in United Arab Emirates.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Digital and conventional impressions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited Arab Emirates
Study dates
1 Oct 2025to 1 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United Arab Emirates1 site, 1 recruiting

  • Dubai Dental Hospital

    Dubai, 505055

    Khadeeja Abdul Rahiman, 00971050953219, khadeeja.abdul@dubaihealth.ae

    Recruiting

Other trials in United Arab Emirates

About this study

Official title: 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:

Read more

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.

Being tested
Digital and conventional impressions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital and conventional impressionsProcedure or surgery

    Also called intra-oral scanning, border-molded impression

    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.

Study groups in NCT07377890
Study groupRoleWhat they receive
Edentulous patientsExperimentalArm 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.
Receives: Procedure: Digital and conventional impressions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 1 week

  2. 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

    Measured: 1 week

Secondary outcomes (2)

  1. 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

    Measured: 1 week

  2. 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

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2026
  2. Study start1 Oct 2025
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07377890
Sponsor's protocol ID
MBRU IRB-2024-107
Status last verified
Jan 2026
First submitted
13 Jan 2026
Last updated
30 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 33289648

  • 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.

    PubMed 35997079

  • 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.

    PubMed 37699190

Questions about this trial

What is this clinical trial studying?

A study testing Digital and conventional impressions in people with Edentulism and Complete Dentures, run by Mohammed Bin Rashid University of Medicine and Health Sciences at 1 site in United Arab Emirates.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trueness of Digital Impressions: Mean root mean square Deviation (mm) between intraoral scanner (IOS) digital impressions and conventional impression scans-per arch (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07377890, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.

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