This prospective study enrolled 30 patients presenting with complete edentulism in both arches. Participants were recruited and received treatment between March 2023 and March 2025 at the Department of Dental and Maxillofacial Sciences, Sapienza University of Rome. Selection criteria included an age of over 65 years, a state of complete edentulism, and socioeconomic status.
The study protocol was reviewed and approved by the Institutional Review Board of the Department of Dental and Maxillofacial Sciences, Sapienza University of Rome. All participants provided written informed consent prior to their inclusion in the study and any study-related procedures in accordance with the Declaration of Helsinki.
Hybrid Digital Prosthetic Rehabilitation Protocol
The prosthetic rehabilitation protocol was designed to include the following sequential clinical and laboratory steps:
1) The first step of the prosthetic rehabilitation protocol involved extraoral and intraoral analysis of the patient’s face (
Figure 1), followed by intraoral assessment. Digital impressions of the edentulous maxillary and mandibular arches were acquired using the Medit i700 intraoral scanner (Medit Corp., Seoul, Korea).
The upper digital impression is recorded starting from landmarks, which are represented by the palatine wrinkles (
Figure 2a). The scanner tip must be positioned almost in contact with the intraoral surfaces that allows the correct registration of the mucosa and teeth. The edentulous ridges are then scanned by positioning the tip in an occlusal position and moving it outwards and inwards of the mouth until both the ridges and the labial and buccal vestibule are adequately recorded. To obtain digital scans of the vestibular areas, the scan was made after retracting the lips and cheeks with the scanner head while maximally stretching the vestibular area with a retractor [
1]. Furthermore, it is essential to record the entire hard palate up to the postdam, the reference limit on which the posterior prosthetic margin must reach.
2) The lower digital impression is always recorded, starting from the edentulous ridges, therefore with the tip directed occlusally, taking the labial or lingual frenulum as reference points for a better scan. The scan is then completed by recording the vestibular and lingual areas of the edentulous ridge, up to the retromolar trigone. A dermographic marker was used to create fixed reference points and facilitate the impression recording. Intraoral scanning was difficult in cases of particularly atrophic mandibular ridges, so an analog step had to be introduced into the digital workflow. In instances of severely atrophic mandibular ridges where achieving a stable and accurate full-arch intraoral scan proved difficult, a modified analog-digital approach was employed: a mucocompressive impression was made using alginate, and this impression was subsequently scanned directly with the intraoral scanner to create the digital model of the mandibular arch (
Figure 2b).
3) The acquired intraoral scan data were exported as Standard Tessellation Language (STL) files. Virtual models and centric registration bases were constructed based on these scans (
Figure 3).
4) The vertex-centric registration bases are tested clinically (
Figure 4). The retention of the two articulations is initially assessed. The upper wax rim is discarded occlusally until an adequate height of the upper arch is determined with the help of the V and F phonemes test. The Rim occlusal inclinator is then heated to establish the inclination of the upper wax rim to be parallel to the Camper plane. The lower articulation base is positioned, the S phoneme test is performed, and the wax is discarded until pronounced correctly. Finally, notches are created on the upper wax rim in the posterior area, and the lower wax rim is heated in the posterior region to ensure the correct interlocking of the two rims that determine the previously established vertical dimension. To determine the interincisive line, the face’s midline and the nose’s tip are taken as a reference, while to record the canine bumps, the wings of the nose are referred to. The interzygomatic distance is also recorded with a caliper to help the technician choose the correct mesio-distal dimension of the frontal sector. The standard mesio-distal distance of the superior centrals is 1:16 of the interzygomatic distance [
2].
Although some studies report a ratio of 1:16 between the mesiodistal width of the central maxillary incisor and the interzygomatic distance, the available scientific evidence suggests that this ratio is not universal and may vary depending on the population and other factors. Therefore, it is advisable to use this ratio as a preliminary guide, adapting it to the specific characteristics of the patient [
3].
5) A 3D facial scan was acquired using a dedicated handheld facial scanner (MetiSmile; Shining 3D Tech Co., Ltd., Hangzhou, China). (
Figure 5) The facial scan was performed with the maxillary registration rim (incorporating the established occlusal plane and incisal edge position) seated intraorally. This procedure allowed for the subsequent superimposition and alignment of the intraoral scan data with the patient’s facial topography in the dental CAD software, facilitating a more aesthetically driven and patient-specific virtual tooth arrangement. This acquisition considered lip support, smile characteristics, and overall facial symmetry.
6) The STL files from the intraoral scans (or scanned impressions), the recorded maxillomandibular relationship, and the facial scan were integrated within the dental CAD software (Exocad DentalCAD, DentalCAD ULTIMATE Rjeka edition; Exocad GmbH, Darmstadt, Germany). A complete 3D virtual patient model was thereby created.
The dental technician performed the virtual setup of denture teeth selected from a digital tooth library (e.g., VITA Physiodens, VITA Zahnfabrik H. Rauter GmbH & Co. KG, Bad Säckingen, Germany; or similar), arranging them according to the recorded occlusal parameters, esthetic requirements, and principles of complete denture occlusion. (
Figure 6) Tools within the software for analyzing occlusal contacts and excursive movements (virtual articulation) were utilized.
7) A monolithic resin prototype of the complete dentures was designed following a virtual esthetic preview and approval. This digital design (STL file) was then used to fabricate a physical prototype via 3D printing for clinical evaluation. (
Figure 7). Finally, the color of the dental elements is chosen based on the VITA color scale.
8) Based on the modifications identified and confirmed during the clinical prototype evaluation, the digital design was finalized in the CAD software. The definitive prosthetic bases were fabricated using a high-impact, esthetic denture base resin, 3D-printed using Digital Light Processing (DLP) technology with a specialized 3D printer (SolFlex 170 HD; Voco GmbH, Cuxhaven, Germany) and a compatible photopolymerizing resin (V-Print dentbase; Voco GmbH) according to the manufacturer’s instructions for printing and post-curing. (
Figure 8a) Prefabricated, multi-layered acrylic resin denture teeth (VITA MFT) corresponding to the selected shade and molds were then bonded into the sockets of the 3D-printed denture bases using a dedicated PMMA-based adhesive system (V-Print C&B temp bond; Voco GmbH, or similar) following strict adherence to the manufacturer’s protocol for surface treatment and bonding. (
Figure 8b) The prostheses were then finished, polished, and delivered to the patient.
Follow-Up and Outcome Measures
A follow-up appointment was scheduled approximately two weeks post-delivery to evaluate patient adaptation, comfort, masticatory function, speech, and the health of the supporting oral tissues. Any necessary minor adjustments to the denture borders or occlusion were performed. Subsequent follow-up appointments were arranged as clinically indicated throughout the 6-month initial observation period. (
Figure 9).
In addition, the GOHAI was administered to all participants by a trained interviewer at the initial baseline appointment (T0, before prosthetic rehabilitation) and again 3 months after the delivery and final adjustment of the new complete dentures (T1). The GOHAI is a 12-item self-reported questionnaire designed to evaluate an individual’s perception of their oral health and its impact on their quality of life across five dimensions: oral function (comfort while eating, talking, swallowing), appearance, pain or discomfort, and psychosocial impact (food restriction, self-consciousness, social interaction). Each item is rated on a 5-point Likert scale indicating the frequency of an experience (e.g., never, seldom, sometimes, often, always). For consistent scoring, responses were coded from 1 (representing the most frequent negative experience or least frequent positive experience) to 5 (representing the least frequent negative experience or most frequent positive experience). GOHAI total scores were calculated by summing the scores for all 12 items, yielding a potential range from 12 (poorest perceived oral health) to 60 (best perceived oral health). For descriptive analysis and interpretation, GOHAI total scores were categorized based on established conventions as follows: 12-20 indicative of very poor perceived oral health, 21-30 poor, 31-40 moderate, 41-50 good and 51-60 excellent [
4].
Statistical Analysis
All statistical analyses were performed using IBM SPSS Statistics for Windows, Version 27.0 (IBM Corp., Armonk, N.Y., USA). Descriptive statistics, including mean, standard deviation (SD), median, and interquartile range (IQR), were calculated for each variable. To evaluate the change in GOHAI scores from T0 to T1, the distribution of the difference scores (T1-T0) was first assessed for normality using the Shapiro-Wilk test. As the assumption of normality for the paired differences was violated (Shapiro-Wilk test, p < .05), the Wilcoxon Signed-Rank Test was employed to determine if there was a statistically significant median change in GOHAI scores following prosthetic rehabilitation. All statistical tests were two-tailed, and a p-value of less than .05 was considered statistically significant.