NCT07290322

Denture Retention of Intra-orally Scanned Versus Extra-orally Scanned Digitally Printed Maxillary Denture in Completely Edentulous Patients

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluate denture retention in intra-orally scanned versus extra-orally scanned digitally printed maxillary dentures in completely edentulous patients. The main question is : 1. Do intra-orally scanned dentures provide better retention compared to extra-orally scanned dentures? Researchers will compare the intra-orally scanned denture group to the extraorally scanned denture group to determine if one method leads to superior retention records. Participants will: • Receive both types of dentures (intra-orally scanned and extra-orally scanned), with a three-week wash-out period between each intervention. The study aims to provide evidence on the optimal scanning method for digitally printed maxillary dentures in edentulous patients.

Detailed description

The goal of this clinical trial is to evaluate and compare denture retention 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 retention 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 objective of this study are: 1\. To determine if intra-orally scanned dentures provide higher denture retention compared to extra-orally scanned dentures. 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 be exposed to The assessment of denture retention which involves measuring the force required to dislodge the denture in different directions .

Conditions

• Complete Edentulism

Interventions

Type	Name	Description
DEVICE	Intaorally scanned methods	the intraoral scanning method involves capturing digital impressions of the oral cavity directly using the 3 shape scanner . this method eliminates the need for traditional impression material providing a more comfortable and precise imaging process , the digital impressions are the utilized to design and fabricate maxillary dentures using 3D printing technology . the intervention focuses on evaluating denture's retention
DEVICE	extraorally scanned methods	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 denture retention

Timeline

• Start date: 2024-12-03
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2025-12-18
• Last updated: 2025-12-18

Locations

1 site across 1 country: Egypt