About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Completely edentulous patients with good local and systemic health.
Patients age ranging from 50 to 70 years old.
Patients with adequate inter-arch space.
Patients with good neuromuscular control.
Disqualifiers
Patients with any oral diseases which may affect denture construction
Patients with oral parafunctional habits.
Patients with tempro-mandibular disorders
Trial design
Crossover
Treatments tested in this trial
0° 3D-Printed Maxillary Complete Denture
DeviceParticipants 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.
45° 3D-Printed Maxillary Complete Denture
DeviceParticipants 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.
90° 3D-Printed Maxillary Complete Denture
DeviceParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Trueness of 3D-printed maxillary complete denture bases
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
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 outcomes
Dimensional deviation of 3D-printed maxillary complete denture bases
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.