Study Results
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Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-11-17
2026-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Each participant will remain in their assigned group for the duration of the 3-month study period, and no crossover between groups will occur. This parallel design allows for a direct comparison of the effectiveness of these two standard-of-care approaches in maintaining occlusal stability during MAD therapy.
PREVENTION
DOUBLE
Study Groups
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Interocclusal Aligner
Arm 1 (Interocclusal Aligner Group):
"Morning Interocclusal Aligner to Maintain Occlusion" Participants in this arm will use a prefabricated thermoplastic device called the AM Aligner each morning immediately after removing their Mandibular Advancement Device (MAD). The aligner will be warmed and then gently bitten into for 2-5 minutes to help reposition the mandible and maintain the original occlusion. This approach is a standard-of-care method aimed at minimizing occlusal changes associated with MAD therapy.
AM Aligner
Intervention Name: AM Aligner (Interocclusal Aligner) Type: Device Manufacturer: (AM Aligner; TAP Sleep Care, Texas, USA)
Description:
The AM Aligner is a prefabricated, commercially available thermoplastic appliance designed to help patients return their mandible to a normal resting position after nighttime use of a Mandibular Advancement Device (MAD). In this study, the aligner will be used each morning immediately after removing the MAD. The participant will bite into the warmed aligner for 2-5 minutes to promote realignment of the mandible and occlusion. This approach aims to minimize or prevent occlusal changes, including posterior open bite and anterior shift, associated with prolonged MAD therapy.
This intervention is distinct from the alternative study arm, which uses a set of guided jaw exercises instead of a physical appliance to achieve the same goal.
The AM Aligner used in this study is a standard-of-care option and is FDA-cleared for this use. It is not investigational.
Daily Jaw Exercises
Participants in this arm will be instructed to perform a standardized set of jaw exercises each morning after removing their MAD. The exercises include side-to-side jaw movements, backward pressure (such as the "thinker's pose"), and gentle simulated clenching.
Exercise
Participants in this arm will perform a standardized set of jaw exercises for 5 minutes each morning immediately after removing their Mandibular Advancement Device (MAD). The exercises are intended to assist in reestablishing the natural occlusal relationship following overnight mandibular advancement.
This routine includes the following movements:
Side-to-side jaw movements Backward pressure to the chin (similar to a "thinker's pose") Gentle simulated clenching
The exercises are performed once daily and take approximately 2-3 minutes to complete. This approach represents a standard-of-care method for minimizing occlusal changes associated with MAD therapy.
Interventions
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AM Aligner
Intervention Name: AM Aligner (Interocclusal Aligner) Type: Device Manufacturer: (AM Aligner; TAP Sleep Care, Texas, USA)
Description:
The AM Aligner is a prefabricated, commercially available thermoplastic appliance designed to help patients return their mandible to a normal resting position after nighttime use of a Mandibular Advancement Device (MAD). In this study, the aligner will be used each morning immediately after removing the MAD. The participant will bite into the warmed aligner for 2-5 minutes to promote realignment of the mandible and occlusion. This approach aims to minimize or prevent occlusal changes, including posterior open bite and anterior shift, associated with prolonged MAD therapy.
This intervention is distinct from the alternative study arm, which uses a set of guided jaw exercises instead of a physical appliance to achieve the same goal.
The AM Aligner used in this study is a standard-of-care option and is FDA-cleared for this use. It is not investigational.
Exercise
Participants in this arm will perform a standardized set of jaw exercises for 5 minutes each morning immediately after removing their Mandibular Advancement Device (MAD). The exercises are intended to assist in reestablishing the natural occlusal relationship following overnight mandibular advancement.
This routine includes the following movements:
Side-to-side jaw movements Backward pressure to the chin (similar to a "thinker's pose") Gentle simulated clenching
The exercises are performed once daily and take approximately 2-3 minutes to complete. This approach represents a standard-of-care method for minimizing occlusal changes associated with MAD therapy.
Eligibility Criteria
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Inclusion Criteria
* diagnosed with SRBD and prescribed Mandibular Advancement Device (MAD) therapy
* Participants will include patients with well restored natural dentition with all posterior teeth, excluding third molars, one missing premolar secondary to orthodontic treatment.
Exclusion Criteria
* anterior cross bite
* posterior cross bite
* existing open bite or implant supported restorations
* tooth mobility
* significant dental caries or periodontitis
* severe bruxism
* planned upcoming dental work including caps, crowns, implants, or braces
* inadequate mandibular protrusion
* severe micrognathia
* large tori
* significant claustrophobia
* significant nasal obstruction
* large oropharyngeal masses or large tonsils
18 Years
ALL
Yes
Sponsors
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American Academy of Orofacial Pain
UNKNOWN
Isabel Moreno Hay
OTHER
Responsible Party
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Isabel Moreno Hay
Associate Professor
Principal Investigators
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Isable Moreno Hay, MS, PhD
Role: STUDY_DIRECTOR
University of Kentucky
Locations
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Orofacial Pain Center - University of Kentucky - Kentucky Clinic
Lexington, Kentucky, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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103755
Identifier Type: -
Identifier Source: org_study_id
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