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Recruiting NCT07377890

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

No phase Interventional Edentulism Complete Dentures Digital Impression Accuracy Dental Impression Techniques

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Digital and conventional impressions.
Who it may be relevant to
Registry conditions: Edentulism, Complete Dentures, Digital Impression Accuracy, Dental Impression Techniques. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Arab Emirates
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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 mol

Primary outcome measures

  • 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]
  • Precision of Digital Impressions: Within-Subject Mean Pairwise RMS Deviation (mm) Across Three IOS Scans (Precision)-per Arch [Time frame: 1 week]
Secondary outcome measures (2)
  • The difference (mm) in mean RMS trueness between the maxillary and mandibular arches is measured. [Time frame: 1 week]
  • Difference (mm) in mean RMS trueness between static (attached) and dynamic (mobile) regions. [Time frame: 1 week]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United Arab Emirates · 1 center
  • Dubai Dental Hospital — Dubai

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. PMID 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. PMID 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. PMID 37699190

Identifiers

NCT: NCT07377890 · MBRU IRB-2024-107

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗