"Patient Satisfaction with Intra-Oral Vs. Extra-Oral Scanned 3D-Printed Dentures: an in Vivo Study"

Cairo University (CU)

Status: Enrolling

Conditions: Complete Edentulism

Treatments: Device: Extra orally scanned; Device: Intra-Oral Scanning Method

Study type: Interventional

Funder types: Other

Identifiers

NCT06846619

12-2024

Details and patient eligibility

About

The goal of this clinical trial is to evaluate patient satisfaction with intra-orally scanned versus extra-orally scanned digitally printed maxillary dentures in completely edentulous patients. The main questions it aims to answer are:

1. Do intra-orally scanned dentures provide higher patient satisfaction compared to extra-orally scanned dentures?
2. Are there significant differences in comfort, fit, aesthetics and phonetics between the two types of dentures?

Researchers will compare the intra-orally scanned denture group to the extra-orally scanned denture group to determine if one method leads to superior patient-reported outcomes.

Participants will:

• Receive both types of dentures (intra-orally scanned and extra-orally scanned), with a three-week wash-out period between each intervention.
• Complete satisfaction surveys to assess comfort, fit, and aesthetics after using each type of denture.

The study aims to provide evidence on the optimal scanning method for digitally printed maxillary dentures in edentulous patients.

Full description

The goal of this clinical trial is to evaluate and compare patient satisfaction with intra-orally scanned and extra-orally scanned digitally printed maxillary dentures in completely edentulous patients. This in vivo study seeks to provide insights into how the scanning method impacts the comfort, fit, and aesthetics of maxillary dentures, ultimately guiding clinicians in choosing the most patient-preferred approach.

Study Design and Objectives

This study involves eight completely edentulous participants who will receive both types of dentures-one set based on intra-oral scanning and another based on extra-oral scanning. A wash-out period of two weeks between the use of each denture ensures that the effects of one intervention do not influence the results of the other. The primary objectives of this study are:

1. To determine if intra-orally scanned dentures provide higher patient satisfaction compared to extra-orally scanned dentures.
2. To assess specific satisfaction factors, including comfort, fit, and aesthetic appearance, for both denture types.

Study Methodology

Participants will undergo the following steps:

1. Scans and Fabrication:

   • Intra-oral scanning will be performed using the 3Shape scanner to capture precise digital impressions of the oral cavity.
   • For the extra-oral scanning, conventional impressions will first be taken, and these will be scanned externally using the same scanner to create digital models.
   • Both types of digital models will be used to fabricate maxillary dentures using 3D printing technology.

2. Fitting and Wash-out Period:

   • Participants will first use one type of denture (either intra-oral or extra-oral scanned) for a designated period.
   • After a two-week wash-out period without wearing dentures, they will switch to the other type of denture.

3. Data Collection:

   • After wearing each type of denture, participants will complete structured satisfaction questionnaire focusing on key parameters: comfort during daily use, overall fit, and aesthetic appeal.

Data Analysis

The study will compare satisfaction scores and qualitative responses between the two scanning methods. Statistical analyses will be conducted to identify significant differences in patient-reported outcomes.

Expected Impact

This study aims to provide clinicians with evidence-based guidance on whether intra-oral or extra-oral scanning results in better patient satisfaction for digitally printed maxillary dentures. By focusing on the user experience, this research contributes to improving prosthodontic care for completely edentulous patients.

Enrollment: 8 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completely edentulous patients
• Angle's Class I skeletal relationship
• Normal facial symmetry
• Cooperative patients

Exclusion criteria

• -Temporomandibular disorders
• Uncontrolled diabetes
• Patient's with neuromuscular disorders
• Severe psychiatric disorders
• Angle's class II and III skeletal relationship.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Intra-Orally Scanned Dentures

Experimental group

Description:

Arm Description: Participants in this arm will receive maxillary dentures fabricated using intra-oral scanning technology. Digital impressions of the oral cavity will be captured directly using the 3Shape TRIOS intraoral scanner, eliminating the need for conventional impression materials. These digital impressions will be used to design and 3D-print the dentures, which will then be fitted and evaluated for comfort, fit, and aesthetics. Participants will wear these dentures for a specified period and provide feedback through structured satisfaction surveys.

Treatment:

Device: Intra-Oral Scanning Method

Device: Extra orally scanned

Extra-Orally Scanned Dentures

Active Comparator group

Description:

Arm Description: Participants in this arm will receive maxillary dentures fabricated using extra-oral scanning technology. Conventional impressions of the oral cavity will first be taken using traditional impression materials. These impressions will then be scanned externally using the 3Shape scanner to create digital models. The digital models will be used to design and 3D-print the dentures, which will then be fitted and evaluated for comfort, fit, and aesthetics. Participants will wear these dentures for a specified period and provide feedback through structured satisfaction surveys.

Treatment:

Device: Intra-Oral Scanning Method

Device: Extra orally scanned