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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:
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:
The study aims to provide evidence on the optimal scanning method for digitally printed maxillary dentures in edentulous patients.
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:
Scans and Fabrication:
Fitting and Wash-out Period:
Data Collection:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-Orally Scanned Dentures | Experimental | Arm Description: Participants in this arm will receive maxillary dentures fabricated using intra-oral scanning technology. Digital impressions of the oral cavity will be captured directly using the 3Shape 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 comfort, fit, and aesthetics. Participants will wear these dentures for a specified period and provide feedback through structured satisfaction surveys. |
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| Extra-Orally Scanned Dentures | Active Comparator | Arm Description: Participants in this arm will receive maxillary dentures fabricated using extra-oral scanning technology. Conventional impressions of the oral cavity will first be taken using traditional impression materials. These impressions will then be scanned externally using the 3Shape scanner to create digital models. The digital models will be used to design and 3D-print the dentures, which will then be fitted and evaluated for comfort, fit, and aesthetics. Participants will wear these dentures for a specified period and provide feedback through structured satisfaction surveys. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-Oral Scanning Method | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Patient satisfaction will be assessed using a Visual Analogue Scale questionnaire covering cleanliness, comfort, esthetics,phonetics and fit | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lujayn A Mahmoud, BDS | Contact | 01000642385 | Lujaynamr@dentistry.cu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of dentistry-Cairo university | Recruiting | Cairo | 22022 | Egypt |
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| Extra orally scanned | 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 patient satisfaction with the dentures based on comfort, fit, and aesthetics. |
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