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

NCT06846619 | Recruiting

• 1 other identifier: 12-2024
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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.

Conditions

Complete Edentulism

Keywords

Intraoral scanning; Extra oral scaning; Complete edentulism; Digital

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction

  Patient satisfaction will be assessed using a Visual Analogue Scale questionnaire covering cleanliness, comfort, esthetics,phonetics and fit

  Assessment will be conducted after patient delivery at 6 months after wearing each denture where as a washout period of two weeks will be observed between the two interventions.

Study Arms (2)

Intra-Orally Scanned Dentures

EXPERIMENTAL

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.

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

Extra-Orally Scanned Dentures

ACTIVE COMPARATOR

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.

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

Interventions

Intra-Oral Scanning Method DEVICE

Intervention Description: The intra-oral scanning method involves capturing digital impressions of the oral cavity directly using the 3Shape scanner. This method eliminates the need for traditional impression materials, providing a more comfortable and precise imaging process. The digital impressions are then utilized to design and fabricate maxillary dentures using 3D printing technology. The intervention focuses on evaluating patient satisfaction with the dentures in terms of comfort, fit, and aesthetics.

Extra-Orally Scanned Dentures; Intra-Orally Scanned Dentures

Extra orally scanned DEVICE

The extra-oral scanning method involves creating conventional impressions of the oral cavity using traditional impression materials. These impressions are then scanned externally using the 3Shape scanner to produce digital models. The digital models are used to design and fabricate maxillary dentures through 3D printing technology. This intervention aims to assess patient satisfaction with the dentures based on comfort, fit, and aesthetics.

Extra-Orally Scanned Dentures; Intra-Orally Scanned Dentures

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry-Cairo university

Cairo, 22022, Egypt

RECRUITING

Central Study Contacts

Lujayn A Mahmoud, BDS

CONTACT

01000642385; Lujaynamr@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Degree Student, Removable prosthodontics department, Faculty of Dentistry, CairoUniversity

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: February 26, 2025
• Study Start: December 3, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)