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

Cairo University (CU)

Status: Active, not recruiting

Conditions: Complete Edentulism

Treatments: Device: extraorally scanned methods; Device: Intaorally scanned methods

Study type: Interventional

Funder types: Other

Identifiers

NCT07290322

21-12-2023

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 8 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

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:

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 .

Treatment:

Device: extraorally scanned methods

Extra-Orally Scanned Dentures

Active Comparator group

Description:

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 .

Treatment:

Device: Intaorally scanned methods