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(1) Background: Obstructive sleep apnea syndrome (OSAS) is a sleep disorder with a high social and health impact. Mandibular advancement devices (MADs) are considered a viable treatment option and a possible first-line treatment in this setting. No study in the literature has investigated clinical aspects of these devices in relation to the procedures used to manufacture them. The aim of this study was to compare the clinical adequacy of MADs produced starting from conventional analog versus digital impressions; (2) Methods: Four patients were recruited. For each of them, two MADs were produced: one starting from an intraoral scan and the other from the digitalization of a plaster model based on analog impressions. Clinical parameters of the two devices were evaluated and compared; (3) Results: No statistically significant differences in the clinical parameters evaluated were found between the two groups of devices; (4) Conclusion: Optical and conventional impressions show similar accuracy in the production of MADs.
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Edoardo  Manfredi
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mandibular advancement device
Double-blind comparison between optical and conventional impressions for the production of mandibular advancement devices
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Edoardo  Manfredi
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DDS, PhD, MSc; Dental School, University of Parma; Department of Medicine and Surgery, Via Gramsci 14, 43126, Parma, PR, Italy.
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Double-blind comparison between optical and conventional impressions for the production of mandibular advancement devices
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                                                                                                                 Article


Double-blind comparison between optical
and conventional impressions for the production
of mandibular advancement devices


Edoardo Bianchi 1                                              used to manufacture them. The aim of this study was
Andrea Toffoli 2                                               to compare the clinical adequacy of MADs produced
Marzia Segù3 *                                                 starting from conventional analog versus digital
Alberto Azzi4                                                  impressions; (2) Methods: Four patients were re-
Guido Maria Macaluso5                                          cruited. For each of them, two MADs were produced:
Simone Lumetti6                                                one starting from an intraoral scan and the other
Edoardo Manfredi7                                              from the digitalization of a plaster model based on
                                                               analog impressions. Clinical parameters of the two
                                                               devices were evaluated and compared; (3) Results:
1
    DDS, PhD Candidate; Dental School, University of           No statistically significant differences in the clinical
    Parma; Department of Medicine and Surgery, Via             parameters evaluated were found between the two
    Gramsci 14, 43126, Parma, PR, Italy. Electronic ad-        groups of devices; (4) Conclusion: Optical and con-
    dress: edoardo.bianchi@unipr.it.                           ventional impressions show similar accuracy in the
2
    DDS, PhD; Dental School, University of Parma; De-          production of MADs.
    partment of Medicine and Surgery, Via Gramsci 14,
    43126, Parma, PR, Italy. Electronic address: andrea.       Keywords: digital dentistry; sleep medicine; man-
    toffoli@unipr.it.                                          dibular advancement device
3
    DDS, PhD, MSc; Dental School, University of Parma;
    Department of Medicine and Surgery, Via Gramsci 14,        Introduction
    43126, Parma, PR, Italy. Electronic address: marzia.
    segu@unipr.it                                              Obstructive sleep apnea syndrome (OSAS) is a sleep
4
    DDS; Dental School, University of Parma; Department        disorder characterized by partial or complete obstruction
    of Medicine and Surgery, Via Gramsci 14, 43126,            of the upper airway during sleep, leading to disrupted
    Parma, PR, Italy. Electronic address: alberto.azzi9@       breathing patterns [1,2]. It is relatively common, affect-
    gmail.com                                                  ing approximately 2-4% of adults in the general popu-
5
    MD, MSc; Dental School, University of Parma; Depart-       lation. While OSAS can occur at any age, it is more
    ment of Medicine and Surgery, Via Gramsci 14, 43126,       prevalent in middle-aged males [3]. Several risk factors
    Parma, PR, Italy. Institute of Materials for Electronics   contribute to the development of this condition, includ-
    and Magnetism, National Research Council, Parco            ing obesity (BMI > 30), upper airway obstructions such
    Area delle Scienze 37/A, 43124, Parma, PR, Italy.          as nasal turbinate hypertrophy, septum deviations or na-
    Electronic address: guidomaria.macaluso@unipr.it.          sal polyps, tobacco and alcohol consumption, and the
6
    DDS, PhD, MSc; Dental School, University of Parma;         presence of craniofacial anomalies like maxillary hypo-
    Department of Medicine and Surgery, Via Gramsci 14,        plasia or micrognathia. The consequences of OSAS are
    43126, Parma, PR, Italy. Electronic address: simone.       significant, impacting various aspects of an individual’s
    lumetti@unipr.it.                                          life. Daytime sleepi-ness, impaired vigilance, and cog-
7
    DDS, PhD, MSc; Dental School, University of Parma;         nitive dysfunction are common symptoms that affect
    Department of Medicine and Surgery, Via Gramsci 14,        a person’s ability to perform daily activities effectively.
    43126, Parma, PR, Italy. Electronic address: edoardo.      These symptoms also contribute to an increased risk
    manfredi@unipr.it.                                         of motor vehicle accidents, occupational injuries, and a
                                                               lower overall quality of life [4]. The diagnosis should be
Corresponding author: marzia.segu@unipr.it; Tel: +39           based on the patient’s medical history and on a clinical
0521 033670                                                    and instrumental examination. Questionnaires like the
                                                               Epworth Sleepiness Scale, Berlin questionnaire, and
Abstract                                                       STOP-Bang questionnaire are used to guide the clinical
                                                               assessment. The most accurate diagnostic examination
(1) Background: Obstructive sleep apnea syndrome               for OSAS is polysomnography, which is performed in a
(OSAS) is a sleep disorder with a high social and              sleep laboratory. Polysomnography involves continuous
health impact. Mandibular advancement devices                  noc-turnal recordings, including measurements of vari-
(MADs) are considered a viable treatment option                ous parameters such as electroen-cephalogram, elec-
and a possible first-line treatment in this setting. No        trooculogram, electromyography, nasal and oral airflow,
study in the literature has investigated clinical as-          respiratory effort, oxygen saturation, body position, and
pects of these devices in relation to the procedures           electrocardiogram. Moreover, considerable evidence


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     Double-blind comparison between optical and conventional impressions for the production of mandibular advancement devices

     suggests that OSAS is independently associated with            Materials and Methods
     cardiovascular disease, cerebrovascular disease, and           In this research study, the focus was on evaluating the
     type 2 diabetes [5,6]. Thus, early diagnosis and effective     clinical parameters of mandibular advancement devices
     management of OSAS are crucial for reducing the risk           (MADs) produced using two different impression tech-
     of these comorbidities. Continuous positive airway pres-       niques: intraoral scans and digitalization of traditional
     sure (CPAP) is the treatment of choice for mild, mod-          plaster models. The aim was to identify which of these two
     erate, and severe OSAS, and should be offered as an            methods might offer the best accuracy for MAD fabrication.
     option to all patients. Alternative therapies may also be      During the experimental phase, both the intraoral scan
     proposed depending on the severity of the OSAS and             and traditional plaster model techniques were utilized
     the patient’s anatomy, risk factors, and preferences [7].      to produce the MADs for each volunteer. These de-
     In recent years, oral appliances (OAs) have emerged as         vices were then thoroughly evaluated based on sev-
     a popular alternative treatment for OSAS and snoring           eral critical clinical parameters. The ease of insertion
     [8]. OAs, specifically mandibular advancement devices          and removal of the MADs was assessed to determine
     (MADs), are recommended for patients with mild to              how user-friendly and manageable they were for the
     moderate OSAS who prefer them over CPAP or who do              volunteers. Adequacy of shape and margins examined
     not respond well to CPAP [7]. MADs cover the upper and         the precision and accuracy of the devices in fitting the
     lower teeth, holding the mandible in an advanced posi-         individual’s dental anatomy. Retention, another cru-
     tion, typically forward by 5 to 11 mm (50-75% of maxi-         cial parameter, gauged how well the MADs stayed in
     mal protrusion) [4], to improve the patency of the upper       place during use, ensuring optimal effectiveness dur-
     airway during sleep by enlarging it and/or by decreas-         ing sleep. Comfort, a significant aspect, was evalu-
     ing its collapsibility. Anterior movement of the tongue or     ated to ascertain the overall satisfaction and tolerance
     mandible can increase the cross-sectional airway size          of the participants with each MAD, aiming to iden-
     and may also improve upper airway muscle tone [9].             tify the technique that provided a more comfortable fit.
       Traditionally, the production of oral devices involved       To achieve this, four healthy volunteers were recruited
     conventional impression taking and manual construc-            as participants from among the patients attending a pri-
     tion of the appliance. However, with advancements in           vate dental office (Table 1).
     computer tech-nology and dental processing, a fully
     digital workflow based on CAD/CAM (Comput-er-Aided
     Design/Computer-Aided Manufacturing) technology has            Table 1. Patients recruited for the study
     become feasible [10]. Intraoral scanners (IOS) have be-
     come widely available and offer an efficient and accu-                                      Sex                 Age
     rate alternative to conventional impressions. Numerous               Patient 1              Male                 40
     studies have reported that current intraoral scanners                Patient 2              Male                 40
     demonstrate clinically valuable accuracy, at least com-
     parable to con-ventional impression-based approaches.                Patient 3              Male                 36
       Whereas in vivo studies report that full-arch impres-              Patient 4              Male                 30
     sions are associated with distortion phenomena, for
     single-tooth restorations or fixed partial prostheses of up
     to 4-5 elements, the scientific literature deems the accu-     The patients selected were all healthy adult men with
     racy of optical impressions to be satisfactory and similar     good oral health. Patients with contraindications to oral
     to conventional impressions. However, for more exten-          devices, such as periodontal disease, dental mobility,
     sive restorations such as partial fixed prostheses with        poor tooth retention, inadequate temporomandibular
     more than 5 elements or full-arch prostheses on teeth          joint range of motion, or extensive tooth loss, were ex-
     or implants, intraoral scanning might not offer the same       cluded from the study. All volunteers had lost no more
     level of precision as conventional impressions [11,12].        than one tooth, excluding third molars, during their life-
     Regarding orthodontic purposes, digital models ap-             time, making them ideal candidates for the research.
     pear to be as reliable as traditional plaster models,          In this study, two impressions of both dental arches were
     and full-arch impressions obtained using IOS can re-           taken from each patient to compare the effectiveness of
     place traditional ones [13-15]. Although the precision         conventional and digital impression techniques.
     of these complete-arch scans is currently considered           The first set of impressions was obtained using a con-
     in-ferior to that obtained using conventional impres-          ventional technique. Monophasic impressions were tak-
     sions, reports also show that IOS is sufficiently ac-          en using a polyvinyl siloxane material and standard im-
     curate for the fabrication of occlusal devices, such           pression trays were utilized to capture the dental arches’
     as Michigan splints, in a fully digital workflow [16,17].      detailed morphology. The conventional method involves
       Currently, no study in the literature evaluates the use      carefully inserting the tray into the patient’s mouth and
     of optical impressions in the production of MADs used          allowing the impression material to set and capture the
     in OSAS treatment, and overall, no study has investi-          teeth and surrounding structures accurately.
     gated aspects such as the accuracy, fit and comfort of         The second set of impressions was obtained using a
     MADs in relation to device manufacturing procedures.           state-of-the-art digital impression system. The CEREC
     The aim of this study is to assess the clinical accuracy       Omnicam® intraoral scanner with CEREC Ortho SW
     of MADs produced using CAD/CAM technology with two             1.2® software (Dentsply Sirona; North Carolina, USA)
     different impression techniques: conventional impres-          was employed for this purpose. The intraoral scanner is
     sion taking and intraoral scanning. By comparing the           a handheld device equipped with advanced optical tech-
     two approaches, researchers hope to shed light on the          nology that allows for the non-invasive capture of the
     potential benefits and limitations of using digital impres-    dental arches in a three-dimensional digital format, pro-
     sions in the production of MADs for patients with OSAS.        viding real-time visualization and accurate digital models


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E. Bianchi et al.

of the patient’s teeth and surrounding oral structures.         software (Dentsply Sirona; North Carolina, USA) was
During the acquisition of both conventional and digital         used for the acquisition of full-arch digital impressions. A
impressions, the intermaxillary relationship was record-        full-arch guided scanning procedure was used, requiring
ed in maximum intercuspation. Furthermore, to ensure            the operator to wield the intraoral scanner throughout the
optimal fit and function of the MADs, the patient’s maxi-       process. The scanner is powder-free and relies on the
mal mandibular protrusion was carefully recorded. This          principle of optical triangulation with video sequencing
measurement considered the distance from the upper              using white LED for image acquisition. All digital scan-
right central incisor to the lower right central incisor dur-   ning procedures were performed by the same expert op-
ing mandibular protrusion movement, according to the            erator. Using Cerec Omnicam® with the Cerec Ortho®
oral devices manufacturer’s indications.                        software, a 3D digital model is generated and available
Once the conventional and digital impressions of the pa-        directly after imaging, and the integrated model analy-
tients’ dental arches were obtained, two Narval CCTM            sis tools allow quick access to the clinical information.
dental devices (Resmed Inc., California, USA) were              The scan data were later exported as STL digital files
produced for each patient using computer-aided design/          and sent to the laboratory in this format, attached to
computer-aided manufacturing (CAD/CAM) techniques.              the order form, through the Narval Easy online portal.
The Narval CCTM devices are bi-block MADs made                  In order to compare the MADs produced starting from
from semi-rigid, biocompatible polymer plastic materials.       the two different impression techniques, a list of clinical
For the devices produced from the traditional impressions,      parameters was drawn up to be used to test the quality
a skilled dental technician transformed the impressions         of the devices.
into plaster models. These plaster models were then             The literature was searched to identify objective clini-
scanned to create accurate digital models. These digital        cal parameters able to define the clinical fit of oral ap-
models served as the basis for designing the mandibu-           pliances, but poor results were found. In fact, most of
lar advancement devices through CAD/CAM processes.              the published studies concern fixed prostheses or use in
To ensure unbiased evaluation, a double-blind proce-            vitro measurements to evaluate device accuracy. Only a
dure was employed for the testing phase. An expert              few studies suggested clinical parameters that may be
dental clinician with specialized training in dental sleep      used to evaluate the accuracy of oral devices, such as
medicine, who was unaware of the type of MAD being              orthodontic appliances or occlusal devices [17-21]. No
used, delivered and evaluated the two devices for each          study that included evaluation of the clinical accuracy of
patient. Additionally, the patients themselves were un-         MADs was found. Supplementing the articles found in
aware of the type of device they were testing. To main-         the literature, a list of parameters was established, with
tain anonymity during the evaluation process, a second          univocal definitions. Numerical scores were provided
operator assigned a unique code to each test device.            for each parameter based on objective criteria. Table 2
This coding system ensured that the evaluator and pa-           shows the list of parameters and scores.
tients could not determine which MAD was conventional           Statistical analysis was carried out by means of paired
and which was digital. After receiving the MADs, the vol-       t-test to compare the scores obtained using the different
unteers were instructed to wear them for several nights         devices for the five parameters considered (insertion, re-
during sleep. They were then asked to provide feedback          moval, adequacy of margins and shape, retention, and
on their experience, particularly regarding the level of        comfort). The aim of the statistical analysis was to re-
comfort achieved and any unexpected events they en-             port differences between the scores obtained by the two
countered while using the devices.                              groups of devices for each parameter analyzed. A com-
The devices consisted of two parts, i.e., an upper and          prehensive assessment of each device was also carried
a lower splint, interconnected by exchangeable rods of          out, considering the total score obtained by summing the
different lengths. Although five design variations were         parameter scores. The comprehensive score was com-
available covering a range of patient needs and ana-            pared between the devices using the same statistical
tomical constraints, only one was selected for this study       analysis method.
(“facial band” for both the upper and the lower jaw), to
ensure that the devices were comparable. However,               Results
in accordance with the manufacturer’s indications and
                                                                Tables 3 and 4 show the single parameter scores ob-
based on the clinical evaluations, one patient was given
                                                                tained by each device, as well as the total score for each
different designs due to his particular dental morphology
                                                                device.
(“incisors full coverage” for both the upper and the lower
jaw for the digital device; “incisors full coverage” for the
                                                                None of the devices were found during the clinical evalu-
lower jaw and “facial band” for the upper jaw for the ana-
                                                                ation to cause side effects (such as gum soreness or
logic device).
                                                                crushing), and none of the patients reported side effects
The amount of mandibular advancement was set at 60%
                                                                or discomfort after wearing them for a few nights.
of maximum protrusion for all the patients. The devices
                                                                Paired t-tests were carried out to test for statistically sig-
were fabricated using CAD/CAM technology starting
                                                                nificant differences between the two groups of devices
from the scanned plaster casts and optical impressions
                                                                for both total scores and single parameters (Figure 1).
of the dental arches. Computer-aided design (CAD)
                                                                The tests were performed using a 95% confidence level
enables high degree of customization to suit the com-
                                                                (definition of statistical significance: p< 0.05).
plex dental anatomy of each patient. A virtual articulator
was used in this stage. Computer-aided manufacturing
(CAM) using selective laser sintering of a biocompatible
                                                                Discussion
polymer material (polyamide) guarantees consistent, in-         The aim of this study was to evaluate the clinical accu-
dustrial-strength manufacturing. In this study, the Cerec       racy of MADs produced both from digital and traditional
Omnicam® intraoral scanner with Cerec Ortho SW 1.2®             impressions. The effectiveness of the devices for the



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     Double-blind comparison between optical and conventional impressions for the production of mandibular advancement devices

     Table 2. Parameters and scores

      CLINICAL PAREMETER                                                         SCORE
                                                0 (low)                        1 (acceptable)                     2 (optimum)
      Insertion                    It is not possible to obtain         The device can be placed        The device can be easily
                                   complete insertion and the           with difficulty, or it is       placed, with no need for
                                   proper positioning of the            necessary to apply high         adjustments (snap fit)
                                   device                               or too little pressure, or
                                                                        it is necessary to make
                                                                        adjustments on the device.

      Removal                      Difficulties occur in re-            The device can be easily        The device can be easily
                                   moving the device / the              removed from oral cavity but    removed by the patient
                                   patient cannot remove the            only after adjustments          with no need for ad-
                                   device independently                                                 just-ments

      Adequacy of margins          Inaccuracies or areas of             Mild inaccuracies are found,    Perfect congruence
      and shape                    excessive pressure on                or the device can be worn       between shape/margins
                                   tissues are found, or the            without discom-fort after       of the device and patient’s
                                   patient reports                      adjustments                     tissues
                                   discomfort wearing the de-
                                   vice as a consequence of
                                   excessive pressure on the
                                   teeth or gums

      Retention                    Retention of the device is           The device dislocates either    The retention of the device
                                   lacking in both the upper            the upper or the lower jaw      is sufficient to allow usual
                                   and lower jaws during mouth          during mouth opening and        oral functions (such as
                                   opening and closing                  closing                         swallowing, mouth ope-
                                                                                                        ning and closing)

      Comfort                      The patient struggles with           The patient feels slight        The patient feels
                                   the device and cannot get            discomfort when wearing the     comfortable wearing the
                                   used to it                           device but bears it             device



     Table 3. Scores obtained from clinical examination of the devices

                                Patient 1                 Patient 2                  Patient 3                     Patient 4
          Parameter
                            Analog      Digital    Analog       Digital       Analog         Digital       Analog         Digital

           Insertion           2            2         2             1            1               2            1                2


           Removal             2            2         2             1            1               2            1                2


         Adequacy of
         margins and           2            2         1             1            2               1            2                2
           shape


          Retention            1            2         2             2            1               2            1                2


           Comfort             2            2         1             0            2               1            2                2




     treatment of OSAS was not evaluated, although consid-                 vices could lead to wastage of time and resources for
     erable evidence exists supporting the effectiveness of                both dental clinics and laboratories. Moreover, ill-fitting
     MADs in this setting.                                                 devices may negatively impact patient comfort and com-
     In the existing literature, no studies have specifically in-          pliance, ultimately affecting the overall effectiveness of
     vestigated aspects such as accuracy, fit, and comfort of              the treatment.
     mandibular advancement devices in relation to device                  Traditionally, the MAD production process involves tak-
     manufacturing procedures. These aspects hold signifi-                 ing impressions using alginate or elastomeric materials.
     cant importance in clinical practice, as poorly fitting de-           However, advancements in technology now enable spe-


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E. Bianchi et al.

Table 4. Total of the scores and arithmetical means obtained by the two different groups of devices


                                                               Total                           Arithmetic mean
                 Parameter
                                                   Analog              Digital            Analog               Digital


                    Insertion                         6                   7                  1.5                1.75

                    Removal                           6                   7                  1.5                1.75

     Adequacy of margins and shape                    7                   6                 1.75                 1.5

                 Retention                            5                   8                 1.25                  2

                    Comfort                           7                   5                 1.75                1.25

             TOTAL SCORE
                                                      24                 28
          (objective parameters)

              TOTAL SCORE
                                                      31                 33
        (including patient’s comfort)




cialized laboratories to work directly from digital scans of      quate accuracy for producing mandibular advancement
dental arches. In modern clinical practice, full-arch scans       devices (MADs). This finding suggests that intraoral
are not only used for MAD fabrication but also for orth-          scanners may be a viable and reliable option for clinical
odontic purposes, such as diagnosis and production of             practice, potentially enhancing the available evidence
orthodontic appliances. While some studies have exam-             in the field of dental sleep medicine. However, it should
ined the accuracy of intraoral scans, they have primarily         be noted that the cost of producing two devices per pa-
been laboratory-based and focused on in vitro measure-            tient, as required for the study’s design, makes this ap-
ments. Only a few studies have conducted clinical as-             proach more suitable for scientific research purposes
sessments on the accuracy of oral appliances produced             rather than routine clinical practice. Nevertheless, some
from full-arch scans, specifically orthodontic appliances         valuable conclusions can still be drawn from the present
or occlusal devices, and no such study has evaluated              study. First, all the tested devices exhibited at least an
MADs. Therefore, the current study’s contribution lies in         acceptable level of accuracy, with none of the devices
its development of a comprehensive set of clinical pa-            considered inadequate in any parameter. While one de-
rameters used to assess the fit of intraoral appliances           vice based on an optical impression received a negative
and facilitate comparisons between different devices.             patient comfort evaluation, this aspect is subjective, and
The parameters established were supplemented with a               the other parameters were deemed more meaningful.
scoring system and provided with detailed definitions, in         Overall, both impression techniques produced satisfac-
order to make them objective and unambiguous. Further-            tory results, suggesting that they can be considered suit-
more, the devices were clinically tested using a double-          able for clinical practice.
blind procedure, to avoid conditioning of any kind. One of        Upon comparing the two groups of devices, no statisti-
the essential achievements of this study was the produc-          cally significant differences were found in the compre-
tion of two different MADs for each patient—one based             hensive evaluation (total score) or individual parameters.
on an optical scan and the other from a traditional im-           This indicates that the accuracy of the MADs fabricated
pression. This comparative approach allowed for a com-            from optical impressions was similar to those made from
prehensive evaluation, considering potential anatomical           conventional impressions.
variations between patients. It is crucial to assess how          Furthermore, it is worth noting that all the devices pro-
these differences might affect the clinical fit and reten-        duced from optical impressions received the maximum
tion of the MADs. By making these direct comparisons,             score for retention. This finding is particularly notewor-
the study aimed to provide more robust evidence for the           thy because retention is a critical aspect of MADs. Poor
clinical use of intraoral scanners in MAD fabrication.            retention can lead to discomfort for patients and com-
The primary limitation of the present study is the rela-          promise the overall effectiveness of the treatment. The
tively small number of patients included in the research,         ability of the devices from optical impressions to achieve
which affects the statistical power and generalizability          maximum scores for retention suggests their general
of the results. However, the study has laid the ground-           high-quality construction and potential clinical utility. A
work for future investigations, and the aspects examined          deficiency in parameters such as comfort or adequacy
herein could serve as a basis for more extensive and              of margins can often be rectified through chairside ad-
robust statistical analyses in subsequent studies with            justments, whereas poor retention is a trickier problem
larger patient cohorts.                                           to solve, suggesting poor general quality of the device.
Despite the limitations, the current study demonstrates           Insufficient retention can, in some cases, even make it
that the use of an intraoral scanner can provide ade-             necessary to remake the device.


10.59987/ads/2023.4.15-21                                                                                                       19
     Double-blind comparison between optical and conventional impressions for the production of mandibular advancement devices




     Figure 1.




     Conclusions                                                      to acknowledge the need for further research involving
     The findings of the current study indicate that mandibu-         larger patient cohorts. Expanding the sample size and
     lar advancement devices (MADs) produced using CAD/               including a more diverse patient population would help
     CAM techniques, whether starting from optical digital            establish more statistically significant conclusions. Con-
     impressions or conventional polyvinyl-siloxane impres-           ducting multicenter studies with standardized protocols
     sions, demonstrate comparable clinical fit and accuracy.         could also enhance the reliability and generalizability of
     These results suggest that a fully digital workflow can be       the findings.
     effectively utilized for MAD fabrication in clinical practice,   Incorporating additional outcome measures could pro-
     offering the possibility of obtaining high-quality devices       vide a comprehensive assessment of the MADs’ per-
     with excellent clinical fit, similar to those produced from      formance and patient satisfaction. Long-term follow-ups
     conventional impressions.                                        to evaluate treatment efficacy, adherence, and potential
     The adoption of CAD/CAM technology in MAD fabrica-               side effects would offer valuable insights into the devic-
     tion has shown promising outcomes, providing a more              es’ overall clinical effectiveness.
     streamlined and efficient approach to device production.         Furthermore, exploring the cost-effectiveness of the digi-
     The digital workflow allows for precise customization and        tal workflow compared to traditional methods would be
     better adaptation to the individual patient’s dental anat-       beneficial for healthcare providers and patients alike.
     omy, potentially leading to improved patient comfort and         Understanding the economic implications could poten-
     treatment efficacy. Additionally, the digital process re-        tially lead to more widespread adoption of CAD/CAM
     duces the reliance on physical materials and manual la-          techniques in dental sleep medicine.
     bor, contributing to cost savings and shorter turnaround         Funding: This research received no external funding
     times for device delivery.                                       Institutional Review Board Statement: The study was
     While the study’s results are encouraging, it is essential       approved by the Unit Internal Review Board (17-1023).


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E. Bianchi et al.

Informed Consent Statement: Informed consent was                       11. Abduo J, Elseyoufi M. “Accuracy of intraoral scanners: a
obtained from all subjects involved in the study. Written                  systematic review of influencing factors”. Eur J Prsthodont
informed consent has been obtained from the patients to                    Restor Dent. 2018 Aug 30;26(3):101-121.
                                                                       12. Kihara H, Hatakeyama W, Komine F, Takafuji K, Takahashi
publish this paper                                                         T, Yokota J, Oriso K, Kondo H. “Accuracy and praticality of
Conflicts of Interest: The authors declare no conflict                     intraoral scanner in dentistry: a literature review.” J Prostho-
of interest                                                                dont Res. 2020 Apr; 64(2):109-113
                                                                       13. Rossini G, Parrini S, Castroflorio T, Deregibus A, Debernar-
                                                                           di GL. “Diagnostic accuracy and measurement sensitivity of
                                                                           digital models for orthodontic purposes: a systematic review”
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10.59987/ads/2023.4.15-21                                                                                                                     21
