Clinical Trial Radar

Participants in this study will be randomly assigned to one of two standard-of-care approaches: using an interocclusal aligner each morning after removing the MAD, or performing daily jaw exercises. Both methods aim to reduce the risk of occlusal changes.

The study will follow participants over a 3-month period and includes dental evaluations, 3D oral scans, and short daily surveys. Findings from this research may help guide best practices for preserving occlusion during MAD therapy.

Currently, continuous positive airway pressure (CPAP) is recognized as the most effective treatment for OSA. However, patients' compliance with CPAP therapy is low, and it is oftentimes not tolerated. Therefore, almost two decades ago, the American Academy of Sleep Medicine approved the use of mandibular advancement devices (MADs) as an alternative treatment option. MADs work by mechanically advancing the mandible and maintaining it in a forward position, thereby decreasing airflow resistance and preventing collapse of the upper airway during sleep. MADs are also used for the cosmetic management of primary snoring.

Despite the promise of MADs in treating SRBD, one of the drawbacks to long-term use is the development of dental side effects. These include palatal tipping of the maxillary incisors, forward tilting of the mandibular incisors, minor mesial shifting of the mandibular molars, and posterior teeth losing contact or developing a posterior open occlusal relationship (POOR). The development of a POOR secondary to MAD use has been estimated to affect approximately 10-12% of individuals using these devices. However, beyond investigating the prevalence of POOR, the long-term consequences remain largely unexplored, with limited studies available. It has been hypothesized that POOR can cause sustained shortening of the lateral pterygoid muscles. As a result, when the patient attempts to achieve maximum intercuspation, the front teeth make contact while the back teeth fail to do so, which can significantly hinder a patient's ability to chew properly, resulting in impaired masticatory function. While this phenomenon is often temporary, resolving within hours or days, in rare instances, it may become irreversible.

Traditionally, simple jaw exercises aiming to stretch the lateral pterygoid muscle are recommended to alleviate or correct these side-effects of MADs. However, an emerging clinical trend is the use of an interocclusal aligner (IOA) following the removal of the MAD to minimize dental side effects, rather than relying solely on jaw exercises. However, the effectiveness of IOAs to prevent the development of POOR secondary to the MAD has not yet been empirically demonstrated.

The interocclusal appliances (interocclusal aligner (IOA)) include a variety of personalized appliances and pre-manufactured devices designed to restore the mandible to its usual pre-treatment position. These tools function by re-calibrating the patient's bite into maximum intercuspation, guiding each tooth back into its original position. Additionally, biting pressure is applied to reposition the condyles, with the goal of re-establishing or preserving proper occlusal alignment in the morning after each night of MAD therapy. The guide is customized to fit the patient's maxillary and mandibular teeth in their pre-treatment maximum intercuspation. Moreover, these devices assist in reversing tooth position changes by providing additional exercises that stretch and engage the jaw muscles.

The interocclusal aligner (IOA) is prepared either chairside or in a laboratory before the patient begins using the oral appliance. These aligners can be fabricated using hard or soft materials, with processed acrylics or thermoplastics being the most commonly used. After wearing the sleep appliance overnight, patients are instructed to bite into the aligner each morning until proper alignment between the maxillary and mandibular teeth is achieved, for as long as necessary for the occlusion to normalize.

To the best of our knowledge, there is currently no scientific evidence to support the use of interocclusal aligner (IOA) to prevent the development of POOR secondary to MAD use. Establishing the efficacy of the interocclusal aligner (IOA) would require a future efficacy trial where patients receiving MAD are randomly assigned to receive either stretching exercises (the standard of care) or use of an interocclusal aligner (IOA). Yet, there are logistical and technological burdens that undermine the feasibility of running such a trial. These include questions regarding the ability to recruit and retain sufficient patients, and questions regarding the ability to accurately measure POOR outcomes (i.e., the primary outcome of interest).

Currently, the presence of POOR is usually assessed using 12-µm shim stock foil (Artus Corp., Englewood, NJ, USA). However, this method may be subjective and does not quantify or visualize the occlusal changes or teeth movements. With the implementation of a digital workflow in dentistry, intraoral scanners are now being utilized to obtain precise 3-dimensional (3D) records of the patient's arch dimensions and occlusion. Intraoral scanners can also produce heat map analysis of the occlusal changes that a patient undergoes as a result of the use of a mandibular device for the management of SRBD, but the use of intraoral heat maps to assess POOR outcomes following treatment with MADs has never yet been validated to our knowledge.

The proposed study aims to collect preliminary data to inform the feasibility and design of a future full-scale efficacy trial comparing the use of daily jaw stretching exercises versus an interocclusal aligner (AM Aligner, Airway Management, LLC) in preventing the development of a posterior open occlusal relationship (POOR) in patients undergoing treatment with mandibular advancement devices (MADs).

The specific aims of the current study are as follows:

• Aim 1: To determine the recruitment and retention rates of participants willing to enroll in a randomized clinical trial comparing stretching exercises to the use of an interocclusal aligner (IOA).
• Aim 2: To evaluate the reliability of intraoral scanning (IOS) in detecting and tracking occlusal changes, such as posterior open occlusal relationship, palatal tipping of the maxillary incisors, proclination of the mandibular incisors, and mesial shifting of the mandibular molars, by comparing positional dental changes to baseline 3D records.

In summary, mandibular advancement devices (MADs) are a promising treatment for SRBDs. However, the devices are associated with significant and impactful postural and occlusal oral remodeling side effects. Currently, there are no established methods to effectively treat these complications. Specifically, this research will explore the efficacy of morning occlusal guides in mitigating POOR, thereby improving the long-term outcomes and patient tolerance of MAD therapy.