NCT06576310

Predictive Factors for Occlusal Changes in Obstructive Sleep Apnea Treatment With Mandibular Advancement Appliance

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 118 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Obstructive Sleep Apnea Syndrome

Interventions

Type	Name	Description
DEVICE	Mandibular Advancement Device	In this research, participation in the protocol seamlessly integrates into routine care at the Odontology Department of the University Hospital of Toulouse. 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 T1) 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).

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-08-28
• Last updated: 2024-08-28