An Innovative Approach to Managing Temporomandibular Disorders Through the Combined Use of Two Oral Devices: A Case Report

Abstract

Temporomandibular disorders (TMD) are increasingly prevalent in the adult population. Given the multifactorial and often chronic nature of TMD, the ideal therapeutic approach must be multimodal and personalized, with a preference for conservative treatments. However, standardized protocols combining occlusal devices and biobehavioral therapy for internal derangement (ID) are still lacking. Case Presentation: A 20-year-old male patient presented with bilateral anteromedial reducible disc displacement, with intermittent locking on the right. He reported joint noises, difficulty chewing, and occasional painful mouth opening. A comprehensive diagnostic workup, including clinical, functional, and radiographic evaluations, was performed. The patient underwent a biobehavioral gnathological therapy involving two oral devices: RA.DI.CA. and By-Te ® Reali. The protocol included personalized exercises, patient education, and behavioural counselling. Results. The patient achieved full remission of pain, disappearance of joint noises, and restoration of mandibular function, without dental movement. Pre- and post-treatment MRI and condylography confirmed improved condyle-disc relationships, increased intra-articular space, and better symmetry of movements, particularly on the right. Conclusion. The combined use of RA.DI.CA. and by-Te ® Reali devices, supported by a personalized functional programme, appears effective in managing TMD with ID. Further studies on larger populations are needed to confirm the efficacy and safety of this protocol.

1. Introduction

Temporomandibular disorders (TMD) are a heterogeneous group of conditions with multifactorial etiopathogenesis that is still not well understood, involving the temporomandibular joints (TMJ), the masticatory musculature, and other anatomically and functionally related structures.

Clinical interest in TMD has increased significantly due to its considerable prevalence, affecting an estimated 5% to 12% of the global adult population [1,2,3], and because it represents a primary source of non-odontogenic pain and dysfunction within the stomatognathic system [4,5].

Patients with TMD vary widely in their symptomatology and often experience arthralgia, muscle pain both localized (myalgia) and widespread (myofascial), referred pain on palpation of the joint and masticatory musculature, otalgia, headache, neck pain, limitation and incoordination of mandibular movements, with possible reducible or non-reducible disc displacements, and joint noises of variable intensity and frequency [6,7].

The onset of symptoms associated with TMD can significantly impact patients’ quality of life.

TMD may present with acute symptomatology or progress toward a chronic condition, characterized by persistent pain and a combination of physical, behavioural, psychological, and psychosocial manifestations.

For this reason, the assessment of such patients requires a bi-axial approach, integrating both the physical-organic and mechanistic aspects of the disorder, as well as its psychosocial components [4].

Over the years, various treatment strategies have been proposed for the management of TMD. These include conservative as well as invasive approaches.

The scientific literature on the topic indicates that several studies have reported generally consistent findings [8,9,10,11,12], recommending the use of the following modalities to be selected and tailored by the clinician based on each individual patient’s needs and timing: oral devices, counselling, behavioural therapy, pharmacological treatment, acupuncture, physiotherapy, and psychotherapy [13,14].

These treatment modalities are classified as conservative and non-surgical and represent the first-line approach for the management of patients with TMD. According to Dimitroulis, they are appropriate for over 90% of cases [15].

According to the same author, surgical procedures, which are categorized into closed techniques (arthrocentesis and arthroscopy) and open procedures (arthrotomy), should be considered only when non-invasive management has failed (in approximately 5–10% of cases), and as the sole therapeutic option in the presence of irreversible and symptomatic structural alterations of the temporomandibular joints [15].

Among the various techniques described, oral devices currently represent one of the most widely used modalities [16,17]. Over time, numerous appliances have been proposed, patented, and employed, featuring a wide range of designs, materials, and applications, some anchored to the upper dental arch, others to the lower.

As a result, clinicians have access to a vast array of dental appliances to be selected according to different clinical scenarios. Conversely, the evidence is limited—with few exceptions, such as the study by Meshkova et al. (2019) [18]—regarding specific selection and application protocols. In clinical practice, these protocols still largely rely on individual clinicians’ experience [16,17,19].

Conversely, the evidence is limited, with few exceptions, such as the study by Meshkova et al. [18], regarding specific selection and application protocols. In clinical practice, these treatment protocols are still largely based on the experience of individual clinicians [16,17,19].

The authors have been focused for many years on the diagnosis and treatment of internal derangement (ID) in patients with TMJ dysfunction, with particular attention to the role of all internal structures in both the etiopathogenesis and clinical manifestations of TMD [20].

As documented in previous publications and supported by over four decades of clinical experience treating thousands of patients affected by a wide range of TMJ disorders, the authors maintain that regardless of the chosen therapeutic strategy, the objective should not only be short-term symptom relief, but also long-term restoration of biomechanical and neuromuscular functions, thereby promoting the overall well-being of both the structures involved and the individual as a whole.

The earlier and more comprehensive the therapeutic intervention, the greater the likelihood of achieving these outcomes.

Among the most widely discussed topics in the literature concerning the treatment of TMD is the role and importance of the positional and functional relationship between the condyle and the disc, as well as the related therapeutic systems (e.g., occlusal splints).

Di Paolo et al. hypothesized that, in cases of condyle-disc conflict, disc pathology may be primarily a consequence of condylar activity [20], a concept that has also been reiterated in more recent literature [21,22].

The latest studies emphasize the significance of the spatial relationship between the condyle and the disc, suggesting that a misalignment between the two structures may serve as a predisposing factor for the development of dysfunctional pathology and contribute to progressive arthritic degeneration [22,23].

The latest research echoes concepts previously expressed by the authors in past decades, which have informed a therapeutic approach aimed at restoring the spatial and functional condyle-disc relationship in cases of ID, following the principles of orthopedic and rehabilitative medicine.

This case report was conducted with the primary objective of restoring internal balance within the temporomandibular joints of a patient diagnosed with reducible disc displacement with intermittent locking (IDC—954.63).

The treatment, described here for the first time in the literature, involved the combined use of two oral devices: the RA.DI.CA. distractor and the by-Te ® Reali appliance (Figure 1).

2. Materials and Methods

2.1. Ethical Aspect

This case report was conducted in accordance with the Helsinki Declaration of 1975, as revised in 2008. The patient was treated in accordance with the Good Clinical Practice Guidelines and signed a written informed consent to authorize the use of his clinical data for research purposes.

2.2. Demographics

M.M., a 20-year-old male patient with permanent dentition, requested a gnathological visit for pain and joint noises that appeared with progressive intensity in the previous six months and that were exacerbated by chewing hard or rubbery foods.

2.3. Chief Complaint

The main symptom reported by the patient was a loud noise during temporomandibular joint movements, accompanied by difficulty in chewing and episodes of painful limitation of mouth opening.

2.4. Diagnosis and Treatment Planning

The patient underwent an initial gnathological evaluation due to localized pain in the right temporomandibular joint (TMJ) and loud joint noises that had been present for approximately 6 to 8 months, worsening during mastication. Panoramic radiography was used to assess dental status and condylar symmetry. The radiograph revealed structural asymmetry with a shorter and wider right condyle compared to the contralateral side, along with signs of arthrosis affecting the right condyle, notably displaying a “duck-bill” deformity of the mandibular condyle.

Furthermore, asymmetries of the occlusal plane on the right side were observed in comparison to the contralateral side—a finding typically associated with unilateral mastication—on the right side, as confirmed by the patient. These structural anomalies accounted for the facial asymmetry detected during the extraoral clinical examination, which was characterized by a reduction in vertical dimension on the right side. The intraoral examination revealed Class I molar relationships tending toward Class III bilaterally, Class I canine relationships, and a deviation of the lower midline to the right by at least 1.5 mm, along with mild crowding of the lower anterior segment. Residual adhesive was detected on the surfaces of some teeth, indicating previous fixed orthodontic treatment (Figure 2).

During the same visit, a clinical record was completed, based on the template routinely used by the Gnathology Unit Service of the Integrated Head and Neck Care at the Department of Policlinico Umberto I, “La Sapienza” University of Rome, including the DC/TMD diagnostic criteria.

As part of the clinical examination, an analysis was performed of the mandibular border movements, both symmetric (opening, closing, protrusion, and retrusion) and asymmetric (right and left laterality), along with a chewing test using an elastic bolus.

A pronounced bilateral clicking was detected during the following phases:

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at the end of the mouth opening (bilaterally),

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at the beginning of mouth closing (bilaterally),

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during protrusion (bilaterally),

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during laterality movements (bilaterally), particularly on the right side during left laterotrusion.

These findings are consistent with the presence of a bilateral condyle-disc conflict, clinically more symptomatic in the right TMJ.

Maximum mouth opening was measured using an electronic digital calliper (Powerfix Profi, Neckarsulm, Germany) and was measured to be 48 mm.

The Rocabado pain map was completed [24], revealing no painful points on the left side, while on the right side, point 5, corresponding to the posterior-inferior synovial zone (zone 5), was reported as painful. During the examination, palpation of the masticatory muscles was performed, revealing tenderness in the right lateral pterygoid muscle, as well as the superficial masseter and ipsilateral anterior temporalis muscles.

At the end of the visit, the patient was prescribed a bilateral TMJ magnetic resonance imaging (MRI) in both closed-mouth and open-mouth positions, and a lateral cephalometric radiograph, along with scheduling of a condylography, all necessary to evaluate the internal structures of both TMJs, to analyze and record mandibular functional movements and joint noises, and to correlate them with the patient’s clinical and therapeutic needs.

At the following appointment, the patient presented the MRI results, the lateral cephalometric radiograph, and condylography was performed (Zebris Medical GmbH, Isny, Germany) for the assessment and registration of condylar movements.

These auxiliary diagnostic procedures were also repeated after the treatment (Figure 3 and Figure 4).

Based on the information gathered from the clinical examination, first-level imaging (orthopantomogram and lateral cephalometric radiograph), second-level imaging (bilateral TMJ MRI in both open- and closed-mouth positions), and condylography, the patient was diagnosed with a bilateral anteromedial disc displacement with reduction, on both the left and right sides, with intermittent locking, as evidenced by the more limited condyle-disc movement on the right side in the open-mouth MRI (Figure 5 and Figure 6).

The internal anatomical condition of the joint structures shows typical signs of an arthritic process, including morphological changes of the disc, which has lost its characteristic biconcave shape, and condylar remodelling, with alterations in the shape of the condylar head.

This degenerative progression is evident both clinically, as the patient reported a gradual worsening of pain and joint noises over time, especially during mastication of hard foods, and radiologically (Figure 6).

As a result, the patient was offered gnathological therapy involving an oral device, behavioural retraining, and counselling.

However, the patient refused the proposed treatment.

Three months later, the patient returned to the clinic following an emergency room visit due to a severe episode of joint locking and agreed to begin the previously proposed treatment.

The patient underwent a biobehavioral gnathological therapy, which included patient education and counselling (explanation of the disorder and proposed treatment, reassurance, and modification of dysfunctional habits). Recommendations included a soft diet, avoidance of chewing gum, refraining from extreme mandibular movements, and alternating bilateral mastication.

The treatment plan involved the use of two oral devices: a distraction splint (RA.DI.CA.) and a combined distraction and repositioning bite (by-Te ® Reali), with the goal of restoring a new functional balance between the condyle and the disc, particularly in the right and left TMJs, to enable physiological mandibular movements.

The therapy also included at-home exercises performed with the two devices. Initially, the patient was instructed to perform them in front of a mirror to ensure correct execution.

Movement cycles were taught using the tell-show-do approach.

At the following visit, new impressions were taken for the fabrication of the two oral devices, along with a wax bite registration necessary for the fabrication of the by-Te ® Reali device.

2.5. The RA.DI.CA Device

The RA.DI.CA. appliance, whose name derives from the acronym of its inventors (Rampello, Di Paolo, and Cascone), was patented on 3 September 1991 (Licence No. 91-000571). It is a distraction splint intended for placement on the maxillary arch. A detailed description of the RA.DI.CA. device, its components, and its underlying biomechanical principles have been extensively reported in previous studies [25,26] (Figure 1a). The appliance consists of six structural components. It includes an upper heat-cured acrylic plate with an internal surface conforming to the occlusal and palatal morphology of the maxillary arch and an external surface articulating with the lower plate. The lower heat-cured acrylic plate presents a corresponding internal surface in contact with the mandibular dentition and an external surface facing the upper plate. The functional elements comprise an anterior hinge, two vestibular orthodontic springs, two or more Adams clasps and/or two ball clasps providing retention, and a vestibular stainless-steel arch.

2.6. The By-Te ® Reali Device

The By-Te ® Reali device, patented by medical doctor Maurizio Reali, derives its name from Reali himself and Teresa, the dental technician who fabricated the device according to his specifications.

It is positioned on the masticatory surface of the mandibular arch and was conceived as a bite designed to promote Neuro-Occlusal Rehabilitation (NOR), following the principles of Pedro Planas [27] (Figure 1b).

When properly crafted, this device supports the restoration of mandibular movement, independently of the patient’s initial occlusal condition, through a motor reprogramming process based on the principles of balancing, centering, and advancement.

It features at least seven adjustment zones, which allow appropriately trained clinicians to calibrate both contact points and thicknesses of the by-Te ® device based on the patient’s clinical and therapeutic needs.

In his book, the author even emphasizes the postural benefits of the device, referring to it as the “eighth cervical vertebra”, both due to its design similarity and its functional role as an anterior cervical-like structure positioned before the atlas and axis, mediating the relationship between the mandible, cranium, and spine [27].

The by-Te ® Reali is made entirely of resin and features broad posterior flanges in the region of the second molars (sevenths) and anterior shields in the incisor and canine region.

Its postural effects will be discussed in future publications.

The device is often fabricated asymmetrically, with differential thickness or contact between the two sides, usually greater on the same side as the symptomatic TMJ, particularly in cases where the mandible is already deviated, with loss of dental vertical dimension (DVO) and articular free space, as seen in the present case.

From this starting condition, the by-Te ® device is carefully managed and can be reprogrammed throughout the course of treatment by monitoring occlusal contacts on the appliance. As these changes, adjustments are made by either adding or removing resin, thus tailoring the bite to the patient’s evolving needs.

Bite registration is performed directly in the patient’s mouth.

During the treatment, the device is usually progressively reduced through targeted adjustments to achieve balanced movements in both laterotrusion and protrusion, with the aim of restoring functional efficiency using the minimal effective device thickness.

2.7. Therapeutic Protocol, Exercises, and Follow-Up

The patient was instructed to wear the by-Te ® Reali splint every night and for 1 h daily, while the RA.DI.CA. device was to be used for 5 min, three times a day. In addition, the patient was asked to perform daily exercises using both devices.

Exercises with the by-Te ® Reali consisted of 10–15 cycles of protrusive and lateral movements, performed for 5 min per day under visual control using a mirror, following training provided by the clinician.

Particular attention was given to protrusive and left lateral movements, as in light of the right-sided intermittent locking caused by posterior condylar displacement and anteromedial disc displacement, these movements stimulate recovery of the condyle-disc balance on the right side. The therapeutic objective was to promote distraction of the condyle downward, forward, and medially, based on MRI findings, functional assessments, and the patient’s clinical symptoms.

Exercises with the RA.DI.CA. involved repetitive opening and closing cycles with the device in place, for a maximum of 5 min, and were performed prior to using the by-Te ® Reali.

The RA.DI.CA. device was used for 2 months as a condylar distractor in combination with the by-Te ® Reali, which continued to be used for 18 months.

The prolonged use of the by-Te ® Reali was justified by functional goals, specifically the need to reorganize neuromuscular activity in the new position suggested by the device, according to the principles of Neuro Myofunctional Orthopedic Rehabilitation (NMOR) as proposed by Reali and Corti. It was also necessitated by the patient’s internal anatomical and functional TMJ conditions, as evidenced in the pre-treatment MRI (Figure 5 and Figure 6).

The patient followed the prescribed exercise routine:

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daily for the first 12 months,

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twice a week between months 12 and 16,

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once a week during the final 2 months of treatment.

Follow-up visits were scheduled for clinical assessment and by-Te ® Reali reprogramming, initially every 15 days for the first 2 months, then monthly until 1 year after appliance insertion.

After 1 year of follow-up, appointments were scheduled every 3 months for an additional 6 months, after which the withdrawal phase began: the patient was instructed to wear the bite on alternate evenings, then twice a week, and finally once a week.

At each visit, occlusal contacts on the appliance were evaluated using 200-micron blue articulating paper and were recorded with the aim of enhancing vertical support on the symptomatic side. This approach was intended to promote medial sliding of the mandible during closure and swallowing.

Resin was selectively added or removed from the anterior shield to allow for balanced movements during protrusion and both right and left lateral excursions.

3. Results and Discussion

TMDs are common in the adult population, and increased reporting of painful TMD symptoms and related psychosocial burden has been described in association with the COVID-19/post-COVID period [28,29]. For clinicians involved in the daily management of TMD, the negative impact of these conditions on patients’ quality of life makes the identification of effective therapeutic approaches a clinical priority [30]. In this context, several studies emphasize the role of conservative, evidence-based treatment strategies as first-line management rather than viewing treatment merely as a therapeutic challenge [31].

In this clinical case, the patient, diagnosed with a bilateral anteromedial disc displacement (reducible on the left side and non-reducible with intermittent locking on the right), was treated using two complementary oral devices: RA.DI.CA. and by-Te ® Reali.

The RA.DI.CA. device was used to mobilize the condyles downward, while the by-Te ® Reali was designed to maintain and promote an increase in intra-articular space between the condyle and the articular cavity and, when needed, promote a change in mandibular posture.

This was achieved by constructing the device using a 3 mm wax bite that guided the mandible leftward at the end of closure, thereby repositioning the mandible and realigning the maxillary and mandibular midlines, including the labial frenum, as suggested by Reali et al. [27].

The RA.DI.CA. was employed to achieve condylar distraction, as described in previous studies [24], while the by-Te ® Reali served to promote, control, and stabilize not only the postural correction but also the functional recovery of the mandible, with the goal of restoring a new condyle-disc balance, guided by clinical findings, first- and second-level imaging, MRI and condylographic data.

The authors emphasize that MRI and condylography are essential for accurate clinical assessment and treatment planning, particularly when designing appliances intended to stimulate and guide the mandible toward an anatomically and functionally appropriate condylar position, consistent with both condylar and disc morphology [32,33].

Achieving this balance is often crucial to resolving articular dysfunction in patients with internal derangement, as widely noted in the literature. In the present case, these same diagnostic findings were equally essential in shaping the functional treatment plan. (Figure 3 and Figure 5).

In this specific case, particular attention was given to protrusive and left lateral movements due to the presence of the right-sided intermittent locking resulting from anteromedial disc displacement. Accordingly, the number of exercises directed toward the non-symptomatic (left) side was tripled to help reduce the condyle-disc distance on the right side [22].

These mobilization exercises were deemed necessary to promote new motor patterns and a restored internal balance of the condyle-disc complex. The patient presented with bilateral posterior condylar displacement and a progressive anteromedial disc displacement, more severe on the right, thereby justifying an increased number of movements toward the left side [34].

Due to the lack of a standardized protocol regarding the combined use of the by-Te ® Reali with the described physiotherapeutic exercises, the authors referred to the literature on bruxism management, which recommends frequent, repetitive, moderate-intensity, and time-limited exercises, tailored to the specific clinical needs of each patient [27].

The occlusal contact design of the by-Te ® Reali was developed considering not only the postural correction but also the swallowing function.

During the first three months of treatment, occlusal contacts on the right side were prioritized over the left to encourage leftward mandibular shift through the gentle forces generated during physiological swallowing. This approach aimed to disrupt habitual neuromuscular patterns and, at the same time, guide the right condyle toward the anteriorly displaced disc, helping to establish new motor schemes consistent with the principles of Neuro-Occlusal Rehabilitation (NOR) and Neuro-Myofunctional Orthopedic Rehabilitation (NMOR).

The posterior flanges of the by-Te ® Reali serve a crucial role: they facilitate condylar distraction, especially during protrusive and lateral movements.

In protrusion, these flanges are anteroposteriorly oriented, sloping from bottom to top, and are shaped to guide straight forward mandibular movements and oblique paths (from the upper second molars to the canines) during lateral excursions.

This distraction effect is particularly evident during lateral movements, allowing downward and forward condylar translation, aimed at controlling articular clicks.

The clinical improvements, beyond patient and practitioner testimony, are objectively documented in the condylography, which reveals more symmetrical post-treatment tracings across all spatial planes, a reduction in retrusive movements—particularly during right laterotrusion—and a more bilateral masticatory pattern compared to the baseline condition. These findings are consistent with MRI images, which demonstrate a bilateral increase in intra-articular space and an improved right condyle-disc relationship compared to the start of treatment. This radiological evidence supports the clinical resolution of the pathofunctional click previously observed during both the initial clinical examination and pre-treatment condylography (Figure 3, Figure 7 and Figure 8) [22].

The by-Te ® Reali ensured the maintenance of intra-articular free space and a reduction in joint pressure throughout the night, and is considered a highly useful device in the management of patients with TMD and internal derangement, offering multiple management possibilities.

Its combined use was supported by nutritional and biobehavioral education, encouraging the development of alternating bilateral mastication, as proposed by Professor Planas, a pattern that was also confirmed by the condylographic examination.

The rehabilitative therapeutic approach focused on patient education, which is essential for promoting awareness and active involvement in the treatment process.

In this specific case, we believe that the customized exercises, prescribed according to the patient’s clinical needs and guided by the presence of the by-Te ® Reali, contributed to enhancing both the effectiveness and performance of the exercises themselves, improving alignment with the therapeutic goals of the case.

Moreover, compliance with the use of oral devices, according to the prescribed modalities and timing, was fully respected. These results are especially achievable when the treatment produces a rapid improvement in symptoms.

It is important to note that these findings are derived from a single case report.

Further studies, including the upcoming publication of a retrospective analysis on a larger population, will be necessary to confirm the efficacy and safety of the proposed treatment and to develop clinical protocols that can be adopted for the management of patients with TMD and ID.

4. Conclusions

Despite the limitations of this study, this clinical case highlights how the combined use of two occlusal splints, in association with a structured physiotherapy exercise programme, may offer promising results in reducing pain and other symptoms related to the temporomandibular joint, and in the management of TMD with internal derangement.

This approach aims to restore a new condyle-disc balance, as well as the function of other internal TMJ structures, by emphasizing the functional relationships among these components during mandibular movements, in accordance with the most recent literature.