Prosthesis, Volume 3, Issue 3 (September 2021) – 7 articles

Unfamiliarity with medical device regulations can sometimes be a barrier to deploying technology in a clinical setting for researchers and innovators. Health service providers recognise that innovation can happen within smaller organisations, where regulatory support may be limited. This article sets out to increase transparency and outline key considerations on medical device regulations from a UK healthcare provider’s perspective. The framework used by Guy’s and St Thomas’ NHS Foundation Trust (GSTFT) for assessing research devices is presented to give an overview of the routes that R&D medical devices take to enter a clinical setting. Furthermore, current trends on research studies involving medical devices were extracted from the GSTFT internal R&D database and presented as the following categories (i) commercial vs. non-commercial, (ii) assessment type and (iii) software vs. non-software. New medical devices legislation will be introduced within the UK in July 2023. It is anticipated regulating software as a medical device may become more challenging for healthcare providers and device manufacturers alike. It is therefore important for different stakeholders involved to work together to ensure this does not become a barrier to innovation. Full article

In oral rehabilitation, the treatment of partial edentulism (PEd) is performed by removable partial dentures (RPD) or assembled prosthetic works (APW) composed of several components, fixed to the prosthetic field (Pa) and a removable one (Pb), in order to facilitate the daily hygiene but also the damping of the occlusal forces applied in mastication. Cobalt-Chromium alloys are materials used to manufacture modern prosthetic assembles. In order for this study to be relevant, it was necessary to standardize the design of the framework (Pa) in terms of shape and volume so that the experiment could be reproducible for the five Co-Cr alloys: 0-A (Co-Cr-Mo), 5-A and 10-A (Co-Cr-Mo-W), 15-A and 16.4-A (Co-Cr-W-Fe) and for the three fabrication methods of dental assembled prosthetic frameworks: refractory duplicate method (RD) resulting removable framework (Pb), direct construction method (DC) resulting removable framework (Pb-) and casting over metal method (CoM) resulting removable framework (Pb+). The time allocated to the adaptation process (AP), mechanical processing and sandblasting, in order to assemble the two components was between 43–70 min, even though the assembly between the Pa-framework and the complementary framework (Pb+) was not necessary, CoM-method hs been provide the elimination of AP step. By applying the arithmetic simple rule of three, the percentages for each of the three methods used were calculated, the values of the difference were obtained. The CoM method improves the joining precision between the components of the removable assembly of prosthetic frameworks by 91.7% compared to the RD method and by 80.62% compared to the DC method. According to the efficiency of the methods used in the precision of joining between frameworks components, their order is: casting over metal, direct construction and refractory duplicate method. Full article

Fabrication of complete dentures (CDs) utilizing computer-aided design and computer-aided manufacturing (CAD/CAM) methods has attracted a lot of attention. The purpose of this paper was to summarize current knowledge about digital CDs and the relevant technology, and to present the application of the new technology in a dental geriatrics case. Initially, some of the challenges regarding digitization of the oral mucosa as a supporting surface of the CDs’ intaglio surface are listed. Next, a brief introduction of the CAD software capabilities regarding CDs is presented. The latest CAM additive and subtractive techniques for CDs are following. Subsequently, the consecutive steps for the construction of a digital CD as part of the prosthodontic treatment of a 90-year-old ambulative female patient are presented. Finally, some considerations about the digital workflow in CD manufacturing are discussed. In conclusion, the new digital technology has clear advantages; however, implementation requires careful planning. The digital workflow is applicable and versatile. Full article

In recent years, medical device regulatory bodies have recognised software-as-a-medical-device (SaMD) as a distinct subgroup of devices. The field of SaMD has been rapidly evolving and encompasses a range of different digital solutions. Many organisations have now started to look into digital healthcare, as a way to solve key global challenges. However, there remains uncertainty regarding how many of these SaMD products are entering the market and to what extent these systems achieve a desired level of general safety once they are in the market. In this study, we utilise data collected from publicly available databases. The data are evaluated for trends and a descriptive analysis is performed of the recall and adverse events associated specifically with SaMD. We find that there is a significant positive trend (p < 0.05) of SaMD registrations, although the number of SaMD registrations remains relative low compared to non-SaMD. This rise in SaMD registrations coincides with increasing levels of recalls and adverse events. More importantly, it becomes apparent that adverse events notification is not yet fit for purpose with regards to SaMD. Full article

Dental implants represent the gold standard for the treatment of single edentulism, even in anterior areas. Today, the basic criteria for implant success has changed from mobility, pain, radiolucency, and peri-implant bone loss (>1.5 mm) to prosthetic level success, aesthetics, soft tissue parameters, as well as patient satisfaction. This case report documents a combination of surgical and prosthetic procedures for the treatment of gingival recessions in the anterior maxilla, appearing after tooth extraction, socket preservation, and staged guided implant placement. Prosthetic management of the temporary restoration, orthodontic treatment, and a connective tissue graft were performed. The decision-making process and step-by-step execution of the treatments are presented to describe the entire clinical and surgical management of the reported case. Finally, good aesthetic outcomes, patient satisfaction, and recovery of the soft tissue recession were observed with the combination of these techniques. Full article

Dental fluorosis is a common disorder caused by excessive fluoride intake during tooth development. The esthetic consequences of dental fluorosis can negatively affect oral health-related quality of life and have lasting psychosocial effects. In severe cases, where the fluorosed enamel is prone to chipping, flaking, and developing caries, minimally invasive procedures are ineffectual and a more substantial restorative approach is required to restore optimal function and esthetics. However, no definitive guidelines exist for the management and treatment of severe dental fluorosis due to the limited evidence available in the literature. This case report describes the full-mouth rehabilitation of a patient with severe dental fluorosis utilizing adhesively bonded all-ceramic crowns, veneers, and overlays. The successful follow-up on this case indicates that adhesively bonded restorations may provide a viable option in the functional and esthetic management of severely fluorosed dentition. Full article