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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Complete Edentulism
• Intervention / Treatment: Device: extraorally scanned methods; Device: Intaorally scanned methods

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 .

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12511
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• completely edentulous patients
• Angle's class I Skeletal relationship
• normal facial symmetry
• comparative patients

Exclusion Criteria:

• tempromandibular disorders
• uncontrolled diabetes
• patients with neuromuscular disorders
• severe psychiatric disorders
• angle's class II and III skeletal relationship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intra-Orally Scanned Dentures; Participants in this arm will recieve maxillary dentures fabricated using intraoral scanning technology . digital impressions of the oral cavity will be captured directly using the 3 shape 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 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
Active Comparator: Extra-Orally Scanned Dentures; Participants in this arm will recieve maxillary dentures fabricated using extraoral scanning technology . conventional impressions of the oral cavity will first be taken using traditional impression material , these impressions will then be scanned externally using the 3Shape scanner to create digital models . these digital models will be used to design and 3D print the dentures , which will then be fitted and evaluated for retention .	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Denture Retention	the patient is observed for three weeks as awash_out period after each type of scan so that i can compare the denture retention across those periods

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Rehab R Abdalla, Cairo University

Publications and helpful links

General Publications

• 1-Comparative Accuracy of Intraoral and Extraoral Digital Scanners by MA Mansoor et al., published in the Journal of Prosthetic Dentistry in 2024. 2.The Accuracy of Intraoral Scan in Obtaining Digital Impressions of Edentulous Jaws by Y Wang et al., published in the Journal of Prosthetic Dentistry in 2024. 3.Comparison of Intraoral and Extraoral Digital Scanners: Evaluation of Surface Topography and Precision, published on ResearchGate in 2020. 4.Effect of Different Scanning Protocols on the Retention of Complete Dentures by SM Fadl et al., published in the Egyptian Dental Journal in 2023.

Helpful Links

• This study, titled "Effect of Different Scanning Protocols on the Retention of Duplicated Maxillary Complete Dentures," investigates how various scanning techniques influence the retention and fit of maxillary complete dentures. It provides insights into

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Digital; Complete edentulism; denture retention; Intraoral scanning; Extra oral scaning
• Other Study ID Numbers: 21-12-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: At this time, no final decision has been made regarding the sharing of IPD. We will consider sharing the data based on ethical guidelines and the research objectives in the future.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No