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临床试验/NCT06576310
NCT06576310招募中不适用

Evaluation of Predictive Factors for Dental Occlusal Changes in the Treatment of Obstructive Sleep Apnea With Mandibular Advancement Appliance

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2025年1月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
118
试验地点
1
主要终点
OCCLUSAL MODIFICATIONS AFTER 6 MONTHS OF OAM TREATMENT

研究概览

简要总结

This research addresses obstructive sleep apnea syndrome (OSAS), affecting 6-12% of French adults, often treated with mandibular advancement devices (MADs). MADs may lead to occlusal modifications, causing a 50% treatment abandonment rate. The study employs surface electromyography to assess masticatory muscle activity before and during MAD use, correlating it with occlusal changes after 6 months. The primary goal is to determine dental displacement profiles post-6-month MAD treatment, providing insights for personalized care and minimizing treatment failures.

详细描述

In this exploratory electro-pathophysiological study, our objective is to provide a significant contribution to understanding the underlying mechanisms of occlusal modifications associated with mandibular advancement device (MAD) treatment in patients suffering from obstructive sleep apnea syndrome (OSAS). Drawing from observational data, the researchers aim to identify specific electrophysiological profiles linked to masticatory muscle activity, correlating with occlusal changes after MAD treatment. This innovative approach involves detailed data collection on electrophysiological profiles, initial clinical characteristics pre-treatment, and post-treatment follow-up data. Focusing on patients from the dentistry department at Toulouse University Hospital, the study seeks to establish correlations between muscle activity recorded before and during MAD treatment and occlusal changes, ultimately defining electrophysiological patient profiles. These profiles could potentially guide personalized care, anticipating risks of occlusal modifications and reducing treatment dropouts or failures.

The study utilizes diverse exams-orthopantomogram, optical impressions, surface electromyography, polysomnography, and research questionnaires. Data collected pre- and post-mandibular advancement device treatment for six months will innovatively analyze the links between masticatory muscle activity and occlusal changes, aiming to define specific electrophysiological patient profiles.

In this research, participation in the protocol seamlessly integrates into routine care at the Odontology Department of the Toulouse University Hospital. The visits include the provision of the orthosis at 3 weeks (T1), with EMGs and digital occlusal analysis. The 6-week follow-up visit (T2) adjusts therapeutic propulsion, subjectively resolving symptoms related to OSAS. At the T0 visit, the researchers collect the polysomnographic monitoring before fitting the orthosis (carried out in the patient's reference sleep laboratory) to assess treatment efficiency.(The end-of-research visit (6 months after T0) comprehensively collects data, including questionnaires on stress, anxiety, sleep quality and quantity, oral habits, temporo mandibular dysfunction pain, and quality of life. Moreover, the researchers collect the polysomnographic monitoring after 3 months fitting the orthosis (carried out in the same patient's reference sleep laboratory than before fitting the orthosis).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • •Patient with complete dentition (up to second molars)
  • •Polysomnography or polygraphy
  • •Diagnosis of OSA
  • •Patient receiving OAM treatment at the Odontology Department of Toulouse University Hospital
  • •Patient with contemporary panoramic and lateral cephalometric X-rays (common practice) taken at the time of orthotic treatment
  • •Individual affiliated with or covered by a social security scheme
  • •Voluntary, informed, written consent, signed by both participant and investigator (prior to inclusion and any necessary research-related examinations).

排除标准

  • •Inability to provide informed consent
  • •Pregnant or breastfeeding patient
  • •Patient with curators, guardians, or legal protection

研究组 & 干预措施

OSA patients with mandibular advancement appliance

Patients with obstructive sleep apnea (OSA) treated with a mandibular advancement device (MAD), monitored for changes in masticatory muscle activity and occlusal modifications over a 6-month period. The study involves routine clinical visits and additional assessments including electromyography (EMG) with and without the appliance, optical impressions, digital occlusion recordings, patient diaries, and questionnaires on quality of life, temporo mandibular dysfunction pain, oral habits, stress and anxiety, and sleep evaluation.

干预措施: Mandibular Advancement Device (Device)

结局指标

主要结局

OCCLUSAL MODIFICATIONS AFTER 6 MONTHS OF OAM TREATMENT

时间窗: 6 month

assessment of occlusal modifications after 6 months of mandibular advancement device (OAM) treatment. Dental occlusion will be measured using digital occlusal analysis with OCCLUSENS® (Bausch; Köln, Germany), considering the extent of contacts (centroid) and their intensity (%), and through morphometric analysis based on optical impressions obtained pre and post-treatment using the TRIOS optical camera (3Shape, Dentsply®)

PRIMARY EXPOSURE VARIABLE: MASTICATORY MUSCLE ACTIVITY

时间窗: 6 month

The primary exposure of interest is the activity of masticatory muscles measured by EMG, in the form of motor-evoked potentials (MEPs in µV/s). This measurement will be conducted at the T1 visit when the orthosis is provided to the patient (3 weeks after inclusion) and 6 months after the inclusion visit. At each measurement time, surface EMG will be conducted bilaterally (4 locations in total), both with and without OAM. The association between muscle activity at inclusion and occlusal modifications will be studied for the primary objective, while the association between muscle activity after 6 months of treatment and occlusal modifications will be explored as a secondary objective.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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