Faculty of dentistry-Cairo university
Cairo, 22022, Egypt
Location status: Recruiting
NCT Number: NCT06846619
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:
1. Do intra-orally scanned dentures provide higher patient satisfaction compared to extra-orally scanned dentures? 2. Are there significant differences in comfort, fit, aesthetics and phonetics between the two types of dentures?
Researchers will compare the intra-orally scanned denture group to the extra-orally scanned denture group to determine if one method leads to superior patient-reported outcomes.
Participants will:
* 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.
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Interventional
Not applicable
Cairo, 22022, Egypt
Location status: Recruiting
The goal of this clinical trial is to evaluate and compare patient satisfaction 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 aesthetics 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 objectives of this study are:
Study Methodology
Participants will undergo the following steps:
Data Analysis
The study will compare satisfaction scores and qualitative responses between the two scanning methods. Statistical analyses will be conducted to identify significant differences in patient-reported outcomes.
Expected Impact
This study aims to provide clinicians with evidence-based guidance on whether intra-oral or extra-oral scanning results in better patient satisfaction for digitally printed maxillary dentures. By focusing on the user experience, this research contributes to improving prosthodontic care for completely edentulous patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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.
Patient satisfaction will be assessed using a Visual Analogue Scale questionnaire covering cleanliness, comfort, esthetics,phonetics and fit
Contact information is provided by the study sponsor or research team.
Cairo University
Other
Patient Satisfaction of Intra-orally Scanned Versus Extra-orally Scanned Digitally Printed Maxillary Denture in Completely Edentulous Patients, in Vivo Study.
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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