NCT06612008

Superimposition of Intra-oral Scans in MAD Therapy for OSA

Superimposition of Intra-oral Scans in Mandibular Advancement Device (MAD) Therapy for Obstructive Sleep Apnea

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Obstructive Sleep Apnea (OSA) affects quality of life and health. Mandibular Advancement Devices (MAD) can help with OSA but may cause dental and jaw changes. This study uses a new 3D scanning method to track these changes and compare two adjustment methods for MAD to find the best approach for patients. Goals: 1. To track dental and jaw changes in OSA patients using 3D scans. 2. To assess the impact of MAD on quality of life and cognitive function. Study Details: The aim of the study is to follow OSA patients at multiple centers over several years, comparing two MAD adjustment methods. Participants will undergo routine fitting and imaging. Outcome: The study aims to reduce dental and jaw changes and to improve MAD treatment and patient outcomes.

Detailed description

Rationale: Obstructive Sleep Apnea (OSA) significantly reduces quality of life and increases the risk of severe health issue. While Mandibular Advancement Devices (MAD) are effective in managing OSA symptoms, they often introduce undesirable dental and skeletal changes, which can have a negative impact on patient satisfaction. Recognizing this issue, this study hypothesizes that using an innovative 3D superimposition technique to track these changes will allow to compare two different titration protocols more precisely and determine the optimal approach for various patient groups. By identifying the most effective titration protocol, the aim is to enhance treatment adherence and treatment success, addressing a critical gap in existing literature and significantly improving patient outcomes in OSA treatment. Objective: 1. Investigate dental and skeletal changes in OSA patients undergoing MAD treatment using an innovative 3D superimposition technique. 2. Assess the impact of MAD treatment on quality of life (QoL) and cognitive function. Study design: A prospective multicentre observational cohort study will be conducted, involving four screening points: at the study's onset and during the first, second, and third annual follow-up assessments. This investigation will involve two patient cohorts undergoing different titration approaches: orthodontic titration and another commonly used titration protocol. Study population: The study will include adults with mild to moderate OSA who will undergo MAD treatment. Intervention: Participants will be fitted with a MAD as part of their routine clinical care. The intervention involves the collection of baseline intra-oral scans (IOS), lateral cephalograms (LCR), orthopantomograms (OPT), and a collection of orthodontic parameters. These assessments will be repeated at each follow-up appointment. Main study parameters/endpoints: 1. Dental and skeletal changes tracked over time using intra-oral scans (IOS), lateral cephalograms (LCR), orthopantomograms (OPT), and complete orthodontic evaluations. 2. Changes in quality of life (QoL) and cognitive function assessed through validated questionnaires. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will experience the routine procedure of MAD fitting and imaging assessments. The study's positive outcomes encompass advancing the knowledge of the enduring impacts of MAD treatment on oral health. Participants will not incur any additional risks by engaging in this research, as it solely involves additional routine diagnostic procedures. The study is group-related, focusing on OSA patients undergoing MAD therapy.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Mandibular Advancement Device	MADs are custom-fitted oral appliances designed to reposition the mandible (lower jaw) forward during sleep, which helps to keep the airway open by preventing upper airway collapse.

Timeline

• Start date: 2025-07-01
• Primary completion: 2028-12-01
• Completion: 2029-07-01
• First posted: 2024-09-25
• Last updated: 2025-07-10