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NCT Number: NCT07290322

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo university

Giza, 12511, Egypt

About this study

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:

  • 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:

  • 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.
  • 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.
  • 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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intaorally scanned methods

Device

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

extraorally scanned methods

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 denture retention

Primary outcomes

  1. Denture Retention

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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