New physiotherapy device for interincisal mouth opening in oral submucous fibrosis patients: A pilot study

INTRODUCTION

Oral submucous fibrosis (OSMF), known as “Vidari” in ancient India, was one of the deceiving and chronic medical disorders that were first identified between 1000 and 800 BC. The ancient Indian physician and surgeon Sushruta is credited with the first documented description of this medical disease. He included it in his foundational work, the Sushruta Samhita. Schwartz J. presented the contemporary definition and characterization of OSMF in 1952. He described OSMF as “An insidious, chronic disease characterized by the deposition of fibrous tissue in the submucosal layer of the pharynx, palate, fauces, cheeks, oro-pharynx, and esophagus, and in the underlying muscles of mastication.”^[1,2]

According to the World Health Organization, 4.96% of people worldwide have OSMF.^[3] In India, the prevalence of OSMF has increased due to the prevalent practice of chewing areca, which varies from 0.03% to 6.42%.^[4,5] Four out of every 1000 adults in rural India suffer from OSMF.^[6]

In India, the estimated incidence of oral submucous fibrosis varies between 0.2% and 0.5%. Among the states most impacted by this illness are Madhya Pradesh, Maharashtra, Gujarat, and Bihar.^[7] Typically, OSMF develops in people between the ages of 20 and 40.^[7]

Treatment options for OSMF include topical corticosteroid administration, antioxidant use, and efficient physiotherapy exercises.^[8]

Offering thorough at-home physical therapy routines for mouth-opening exercises are always in demand. These activities are essential for enhancing patients’ ability to speak and eat with their mouths, as well as for improving interincisal mouth opening (IIMO).^[8-10]

Conventionally, patients with OSMF in stage I through III have long been advised to receive physiotherapy utilizing a stack of ice cream sticks placed as far posteriorly as is practical between the upper and lower teeth. Studies evaluating the efficacy and patient compliance of the ice cream stick approach for physiotherapy in patients with OSMF were scarce, despite its widespread use.

Consequently, there is an urgent need to create specialized equipment made just for OSMF patients. To maximize efficacy and patient comfort, these innovative devices should enable a regulated and gradual stretching of the oral tissues. They may also incorporate cutting-edge technology.

A device for at-home physical therapy was developed using 3D printing technology. A pilot study of ten patients was carried out. These patients participated in the device’s pilot testing to assess the mechanical features of the device, including its ability to improve interincisal mouth opening (IIMO), comfort (pain and control) and satisfaction.

MATERIAL AND METHODS

The strategy and design of the mouth-opening device were completed in cooperation with the engineering department and experts in biomedical devices. The biomedical device expert was shown the fundamental idea and design and had a discussion about it. The device’s strength, biocompatible material, cost-effectiveness, patient handling, device size, and mouth-opening mechanism were among the topics discussed. The device’s intended use was to treat OSMF, and 3D printing technology was used in its production. The finished product is ready for patient testing after numerous iterations [Figure 1].

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Figure 1:

New device for interincisal mouth opening.

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Pilot study methodology

Devices were provided to ten clinically diagnosed cases of OSMF stage I–III, based on Khanna and Andrade classification, following approval from the Institutional Ethical Committee. Informed consent was obtained before enrolling these patients. Patients were instructed to give up chewing areca nut; local application of triamcinolone acetonide ointment twice daily was prescribed; oral antioxidant was prescribed once daily; and a novel physiotherapy equipment was prescribed to be used twice daily for 15 min each for a month. This combined medication therapy approach was used in accordance with Patil et al.^[11] Patients’ baseline parameters, such as IIMO, were recorded using a Vernier caliper [Figure 2]. Patient comfort (pain and control) and device satisfaction (feedback received after using the device) were also solicited. Following a follow-up visit after 1 month, the same parameters were recorded. To assess the effectiveness of the device in mechanically increasing mouth opening, a comparison of the IIMO was made between the initial visit and 1 month later.

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Figure 2:

Interincisal mouth opening measurement in oral submucous fibrosis patient using Vernier caliper.

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RESULTS

Results of pilot testing show observable improvement in IIMO in device user after 1 month. Maximum patients showed comfort, ease of use, and satisfaction after using the device. Strengths and weaknesses of the device were also identified during this phase.

The age range of the study patients was 21–60 years old, with an average age of 35.5 years. Men (70%) outnumbered women (30%). OSMF Stage I (20%), Stage II (70%), and Stage III (10%) were the clinical stage distribution [Table 1].

1. The mean mouth opening of OSMF patients improved, according to quantitative data, and this improvement was shown to be statistically significant (P < 0.0006).

2. After using the device for a month, a 1.8 mm difference in a mouth opening was discovered.

3. This indicates that the device worked well for these people [Tables 2 and 3, Graphs 1 and 2].

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Graph 1:

Distribution of improvement in interincisal mouth opening (IIMO) before and after device use.

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Graph 2:

Improvement in mean interincisal (IIMO) mouth opening in device user after follow up visit.

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In this case, comfort with device use refers to the patient’s being questioned about any pain they may be experiencing, including tissue, tooth, and temporomandibular joint dysfunction pain. The majority of patients (90%) said that they felt comfortable using the physiotherapy device [Table 4, Graph 3].

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Graph 3:

Comfort [Pain, comfort, control] with device use. (Y: Comfortable to use, N: Uncomfortable to use.)

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Patients were questioned about how simple it was to handle and transport the physiotherapy device. About 90% of patients said using the device was simple, while one patient did not find it easy [Table 5, Graph 4].

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Graph 4:

Ease of use [Portability]. (Y: Comfortable to use, N: Uncomfortable to use.)

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A question concerning overall device satisfaction was posed. A maximum of 80% of patients expressed satisfaction with their use of the device, compared to 10% who expressed negative satisfaction and 10% who were unable to respond [Table 6, Graph 5].

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Graph 5:

Satisfaction with device use [Device feedback].

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DISCUSSION

Oral submucous fibrosis is a precancerous condition that is becoming more common in the Indian subcontinent. It is caused by chewing areca nut or areca nut mixed with tobacco with a estimated incidence rate of 0.4%. Early OSMF discovery is critical because it allows for timely treatment to halt the disease’s progression and possibly fatal consequences, like oral cancer.

To control OSMF, a variety of therapeutic modalities have been studied; some have shown promising results in reducing the progression of the disease and even partially reversing its effects. These therapeutic approaches include pharmaceutical interventions such as the use of corticosteroids, antioxidants, and other anti-inflammatory drugs, in addition to nonpharmacological strategies, including physiotherapy and dietary modifications.^[12]

With participants ranging in age from 21 to 60, OSMF is generally observed in the 35.5-year-old age group in the present study. The outcomes matched those of studies by Pandiar et al.^[13] and Hazarey et al.^[14] However, according to Hazarey et al.,^[14] OSMF has recently become increasingly prevalent in a younger age range.

Based on the study’s gender distribution, men were found to have an increased risk of OSMF compared to women. This is consistent with earlier studies, as the ones carried out by Hazarey et al.^[14] Male-to-female ratio of 4.9:1 was reported by Hazarey et al.^[14]

In the present study, OSMF stages I (20%), II (70%), and III (10%) made up the clinical stage distribution.

The improvements in IIMO found in this study were statistically significant (P < 0.005). This showed how well the PT equipment functioned for the patients with OSMF in this pilot study group. This improved that mouth openness was 1.8 mm more than it was before physiotherapy began.

Various physiotherapy modalities have been found to be helpful at various OSMF phases. The applied procedures’ efficacy, mobility, comfort, satisfaction, and ease of use were not assessed, though. The goal of the present study was to show how the study tool, which was built especially for physiotherapy exercises like stretching the oral mucosa in patients with OSMF, works.

A small number of research have employed mouth-opening devices; Patil et al.’s study is one of note.^[11] Every patient in the experimental group received an ice cream stick workout regimen, oral antioxidants, and clobetasol propionate corticosteroids. Each of the two subgroups – mouth exercising device Group A and non-mouth exercising device (MED) users’ Group B – consists of three individuals. The MED seems to aid in improving oral opening in patients with OSMF when used in conjunction with local injection and/or surgical treatment.

Li et al.,^[15] after utilizing the reasonably priced EZ Bite device, mouth opening and oral health quality of life (OHQOL) greatly improved. There are certain flaws to this study, including an incomplete explanation of the design. There was no medication given. It is unknown if patients with oral cancer who have trismus receive treatment.

Reddy et al.,^[16] the device owned by Shekar was used. Three OSMF patients used the equipment throughout their physiotherapy sessions. To improve mouth opening in patients with OSMF, oral physiotherapy induces tissue remodeling. Other physiotherapy techniques, such as mouth opening with therapeutic ultrasound and microwave diathermy, have been found to be successful. Dani and Patel,^[17] and Shahbaz et al., mucosal flexibility is increased by improved circulation, submucous fiber separation, and local tissue reorganization brought about by the MED.^[18] The scientists have found that when oral antioxidants and topical triamcinolone 0.1% are taken together, the MED helps that patients with OSMF enhance their interincisal distance.^[18] The reviews author, Gondivkar et al., gathered the research done between 1996 and 2019. Important observations in this review were that the conclusions of said mode of action were not supported by pathophysiological alterations at microscopic as well as molecular levels.^[19] The author listed the benefits and drawbacks of several mouth-opening tools (MEDs).

CONCLUSION

In early stage OSMF patients, the current pilot study demonstrated efficacy in enhancing IIMO. Further, research is required to examine the device using a larger sample size and a more robust study methodology.