Patient Satisfaction of Intra-orally Scanned Versus Extra-orally Scanned Digitally Printed Maxillary Denture in Completely Edentulous Patients, in Vivo Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Cairo University
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Patient satisfaction
Study Overview
Brief Summary
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:
- Do intra-orally scanned dentures provide higher patient satisfaction compared to extra-orally scanned dentures?
- 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.
Detailed Description
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:
- To determine if intra-orally scanned dentures provide higher patient satisfaction compared to extra-orally scanned dentures.
- To assess specific satisfaction factors, including comfort, fit, and aesthetic appearance, for both denture types.
Study Methodology
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Completely edentulous patients
- •Angle's Class I skeletal relationship
- •Normal facial symmetry
- •Cooperative patients
Exclusion Criteria
- •-Temporomandibular disorders
- •Uncontrolled diabetes
- •Patient's with neuromuscular disorders
- •Severe psychiatric disorders
- •Angle's class II and III skeletal relationship.
Arms & Interventions
Intra-Orally Scanned Dentures
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.
Intervention: Intra-Oral Scanning Method (Device)
Intra-Orally Scanned Dentures
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.
Intervention: Extra orally scanned (Device)
Extra-Orally Scanned Dentures
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.
Intervention: Intra-Oral Scanning Method (Device)
Extra-Orally Scanned Dentures
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.
Intervention: Extra orally scanned (Device)
Outcomes
Primary Outcomes
Patient satisfaction
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Lujayn Amr Mahmoud
Master Degree Student, Removable prosthodontics department, Faculty of Dentistry, CairoUniversity
Cairo University