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

Mohammed Bin Rashid University of Medicine and Health Sciences

Status: Enrolling

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

Treatments: Procedure: Digital and conventional impressions

Study type: Interventional

Funder types: Other

Identifiers

NCT07377890

MBRU IRB-2024-107

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Edentulous patients

Experimental group

Description:

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.

Treatment:

Procedure: Digital and conventional impressions