3d Printing, Complete Edentulism, Digital Denture, Maxillary Complete Denture Rehabilitation, Prosthodontics
Conditions
Keywords
Digital dentistry, Patient satisfaction, Dimensional accuracy, Denture trueness, Layer thickness, Build orientation, CAD/CAM dentures, Additive manufacturing, Three-dimensional printing, Maxillary complete denture, Complete edentulism
Brief summary
This randomized crossover clinical trial aims to evaluate the effect of different three-dimensional (3D) printing orientations and layer thicknesses on the trueness, dimensional accuracy, and patient satisfaction of maxillary complete dentures in completely edentulous patients. Each participant will receive two maxillary 3D-printed complete dentures fabricated using the same printing orientation (0°, 45°, or 90°) with two different layer thicknesses (50 μm and 100 μm) in a crossover sequence. The study will compare the influence of these printing parameters on denture accuracy and patient-reported outcomes to identify the optimal 3D printing settings for complete denture fabrication.
Detailed description
This prospective randomized crossover clinical trial is designed to evaluate and compare the effect of different three-dimensional (3D) printing orientations and layer thicknesses on the trueness, dimensional accuracy, and patient satisfaction of maxillary complete dentures in completely edentulous patients. The study will include completely edentulous patients requiring maxillary and mandibular complete dentures. Each participant will receive two maxillary complete dentures fabricated using 3D printing technology with the same printing orientation but two different layer thicknesses (50 μm and 100 μm) in a crossover sequence. Participants will be randomly allocated to one of three printing orientation groups (0°, 45°, or 90°), with five participants in each group. The three printing orientations being compared are: 1. 0° Build Orientation: Maxillary denture bases will be fabricated at a 0° printing orientation using both 50 μm and 100 μm layer thicknesses. 2. 45° Build Orientation: Maxillary denture bases will be fabricated at a 45° printing orientation using both 50 μm and 100 μm layer thicknesses. 3. 90° Build Orientation: Maxillary denture bases will be fabricated at a 90° printing orientation using both 50 μm and 100 μm layer thicknesses. Each participant will wear each denture for a three-month evaluation period. The primary outcomes of the study are trueness of the printed denture bases, assessed by comparing the scanned denture base STL files with the original CAD design, and patient satisfaction, evaluated using a Visual Analogue Scale (VAS) for aesthetics, speech, masticatory efficiency, hygiene, and comfort. Dimensional deviation of the denture bases will also be assessed through three-dimensional superimposition analysis at denture insertion and after three months of use. The findings of this study will help identify the optimal combination of 3D printing orientation and layer thickness for the fabrication of maxillary complete dentures, contributing to improved manufacturing accuracy and enhanced patient satisfaction with digitally fabricated complete dentures. Primary Outcome Measures 1. Trueness of 3D-printed maxillary complete denture bases Description: To evaluate the trueness of the printed denture bases fabricated using different printing orientations (0°, 45°, and 90°) and layer thicknesses (50 μm and 100 μm). Method of assessment: The STL file of each printed denture base will be scanned using an extraoral scanner and superimposed with the original CAD design to determine trueness. Time Frame: At denture fabrication (before clinical insertion). 2. Patient Satisfaction Description: To compare patient satisfaction with dentures fabricated using different 3D printing orientations and layer thicknesses. Method of assessment: Visual Analogue Scale (VAS; 0-10) evaluating aesthetics, speech, masticatory efficiency, hygiene, and comfort. Time Frame: 15 days after insertion (baseline) and 3 months after insertion of each denture. Secondary Outcome Measure Dimensional Deviation of 3D-printed Maxillary Complete Denture Bases Description: To evaluate the dimensional stability of the denture bases fabricated with different printing orientations and layer thicknesses. Method of assessment: Three-dimensional superimposition of scanned STL files to visualize and quantify dimensional deviation. Time Frame: At denture insertion and after 3 months of clinical use for each denture.
Interventions
Participants will receive maxillary complete dentures fabricated using a 0° three-dimensional (3D) printing orientation. Each participant will receive two dentures printed with 50 μm and 100 μm layer thicknesses in a crossover sequence. This intervention is intended to evaluate the effect of the 0° build orientation on denture trueness, dimensional deviation, and patient satisfaction.
Participants will receive maxillary complete dentures fabricated using a 45° three-dimensional (3D) printing orientation. Each participant will receive two dentures printed with 50 μm and 100 μm layer thicknesses in a crossover sequence. This intervention is intended to evaluate the effect of the 45° build orientation on denture trueness, dimensional deviation, and patient satisfaction.
Participants will receive maxillary complete dentures fabricated using a 90° three-dimensional (3D) printing orientation. Each participant will receive two dentures printed with 50 μm and 100 μm layer thicknesses in a crossover sequence. This intervention is intended to evaluate the effect of the 90° build orientation on denture trueness, dimensional deviation, and patient satisfaction.
Sponsors
Study design
Intervention model description
Participants will be randomly assigned to one of three 3D printing orientation groups (0°, 45°, or 90°). Within each group, each participant will receive two maxillary complete dentures fabricated using the same printing orientation but with two different layer thicknesses (50 μm and 100 μm) in a crossover sequence. Each denture will be worn for three months before crossing over to the alternate layer thickness. The crossover design allows within-subject comparison of the effect of layer thickness on trueness, dimensional deviation, and patient satisfaction while minimizing inter-participant variability, whereas comparisons among the three groups will evaluate the influence of printing orientation.
Eligibility
Inclusion criteria
1. Completely edentulous patients with good local and systemic health. 2. Patients age ranging from 50 to 70 years old. 3. Patients with adequate inter-arch space. 4. Patients with good neuromuscular control.
Exclusion criteria
1. Patients with any oral diseases which may affect denture construction 2. Patients with oral parafunctional habits. 3. Patients with tempro-mandibular disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trueness of 3D-printed maxillary complete denture bases | immedtiate | The trueness of the printed maxillary complete denture bases will be evaluated by comparing the STL file of each scanned denture base with the original CAD design using three-dimensional superimposition analysis. |
| Patient satisfaction | 3 months | Patient satisfaction will be assessed using a 10-point Visual Analogue Scale (VAS) evaluating aesthetics, speech, masticatory efficiency, hygiene, and comfort after wearing each maxillary complete denture. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dimensional deviation of 3D-printed maxillary complete denture bases | 3 months | Dimensional deviation will be evaluated by superimposing the scanned STL files of the denture bases to visually and quantitatively assess three-dimensional deviation after fabrication and clinical use. |
Countries
Egypt
Contacts
Faculty of Dentistry, Tanta University, Egypt