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临床试验/NCT07103941
NCT07103941招募中不适用

Effectiveness of Interocclusal Aligner (IOA) on Preventing Occlusal Changes in Patients Treated With a Mandibular Advancement Device (MAD): A Preliminary Study

Isabel Moreno Hay2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年11月17日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
2
主要终点
Number of participants enrolled in the study

研究概览

简要总结

This study is evaluating two standard-of-care strategies used to prevent bite changes (occlusal changes) in patients treated with a Mandibular Advancement Device (MAD) for sleep-related breathing disorders such as obstructive sleep apnea (OSA). While MAD therapy is effective, it can lead to changes in how the teeth fit together, including the development of a posterior open bite.

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.

详细描述

Sleep-related breathing disorders (SRBD) are a group of disorders characterized by abnormal breathing during sleep, and common SRBD conditions encompass primary snoring and obstructive sleep apnea (OSA). Obstructive sleep apnea (OSA) is characterized by recurring episodes of partial or complete upper airway obstruction during sleep. This condition can result in daytime exhaustion, cognitive impairments, diminished quality of life, and elevated risks of cardiovascular and cerebrovascular illnesses, as well as increased mortality. OSA has also been linked to the development and progression of painful conditions such as temporomandibular disorders (TMD) and other orofacial pain conditions.

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult participants (≥18 years)
  • 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.

排除标准

  • pervious orthognathic surgery
  • 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

研究组 & 干预措施

Interocclusal Aligner

Active Comparator

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.

干预措施: AM Aligner (Device)

Daily Jaw Exercises

Active Comparator

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.

干预措施: Exercise (Behavioral)

结局指标

主要结局

Number of participants enrolled in the study

时间窗: 3 months

Recruitment will be measured by tracking the number of participants who agree to enroll in a randomized clinical trial comparing stretching exercises to the use of an interocclusal aligner (IOA).

次要结局

  • Change in posterior occlusal contact relationship from baseline(Baseline, 4 weeks from baseline, 12 weeks from baseline)

研究者

发起方
Isabel Moreno Hay
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Isabel Moreno Hay

Associate Professor

University of Kentucky

研究点 (2)

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