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Case Reports
. 2023 Sep 12;59(9):1647.
doi: 10.3390/medicina59091647.

A New Model of Salivary Pacemaker-A Proof of Concept and First Clinical Use

Affiliations
Case Reports

A New Model of Salivary Pacemaker-A Proof of Concept and First Clinical Use

Cristian Funieru et al. Medicina (Kaunas). .

Abstract

Background and Objectives: Saliva is of utmost importance for maintaining oral health. Management of saliva flow rate deficiency recently includes salivary neuro-electrostimulation. The aim of this paper is to present a new model of salivary pacemaker-the MICROSAL device (MD), an intelligent, miniaturized, and implant-supported oral device used for salivary stimulation. Materials and Methods: This report presents the development, calibration, and first clinical tests which involved the MD. The novel features of this device are the pH sensor and the fact that it communicates with the patient's smartphone, where oral wetness and pH are graphically exposed. Saliva samples were taken before and after the MD was used on a 68-year-old patient suffering from post-irradiation xerostomia, and albumin and total protein were analyzed. Results: The device uses up to 3 V and time intervals of 2 s seconds for stimulation. The total volume of all saliva samples collected during the clinical trial was almost seven times higher after the device was used. Albumin decreased from a maximum of 0.15 g/dL to 0.04 g/dL, and total proteins from 0.65 g/dL to 0.21 g/dL, after salivary stimulation. Conclusions: The MD increased saliva secretion of the patient, and we are confident it will be a good solution for future management of salivary gland hypofunction.

Keywords: dental implant; salivary secretion device; xerostomia.

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Conflict of interest statement

The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.

Figures

Figure 1
Figure 1
The MICROSAL device (MD) scheme: (A) main hole from the upper case (made for the sensors to be in contact with saliva), (B) microcontroller, (C) mini-antenna used for sending signals to the smartphone via Bluetooth technology, (D) one of the electrodes used for stimulation, (E) a wire which makes the connection to the batteries and activates the system when it is put in its case, (F) the upper part of the case, made from polypropylene, (G) the fastening elastic system (clips), (H) the downer part of the case, made from titanium alloy, (I) a metallic extension, also made from titanium alloy, (J) implant central cover screw, (K) the dental implant, Tehnomed system™, (L) the central part of the screw, (M, O) batteries, (N) the coating material (PanacolVitralit 2004 F), (P) the second electrode for stimulation, (R) printed circuit board (PCB), and (S, T) wetness and pH sensors.
Figure 2
Figure 2
Mounting the MICROSAL device (MD): (A) the printed circuit board (PCB); (B) the MD out of its case; (C) the upper part of the case, made from polypropylene; (D) the lower part of the case, made from titanium alloy; (E) the implant central cover screw; (F) the metallic extension, made also from titanium alloy; (G) the central screw and the screwdriver, Tehnomed™ system; (H,I) the titanium case and the metallic extension are fixed on a dummy dental implant; (J) the lower part of the case and the two orifices for the electrodes; (K) the inside of the MD; (L) the operation is complete after the upper case is fixed.
Figure 3
Figure 3
In vitro tests of the two sensors: (A) the humidity-resistive sensor response; (B) the pH N-ISFET sensor response.
Figure 4
Figure 4
The MICROSAL device (MD) in the oral cavity.

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