Clinical trial NCT06612008: Superimposition of Intra-oral Scans in MAD Therapy for OSA
Official title: Superimposition of Intra-oral Scans in Mandibular Advancement Device (MAD) Therapy for Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea
Obstructive Sleep Apnea Syndrome
Oral Appliance Therapy
Mandibular Advancement Device
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: Academic Centre for Dentistry in Amsterdam
First posted: 2024-09-25
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants of the research will be recruited from the Department of Oral and Maxillofacial Surgery at 'Isala Hospital Zwolle' and from the orthodontic practice 'Orthodontisten Heemstede', both located in the Netherlands.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Adults ≥ 18 years of age
* Patients with a diagnosis of OSA
* Patients with an apnea-hypopnea index (AHI) of 5 until 30 events per hour
* Patients initially treated with MAD

Exclusion Criteria:

* Patients under 18 years of age
* Patients without a diagnosis of mild to moderate OSA
* Patients undergoing other treatments for OSA
* Patients previously undergone MAD treatment (this also includes over the counter boil and bite MADs)
* Patients diagnosed with central sleep apnea
* Patients undergoing orthodontic treatment (e.g. braces)
* Pregnant patients
* Patients with craniofacial anomalies or syndromes (e.g., Treacher-Collins, Down, Pierre-Robin, Marfan),
* Patients undergoing cancer treatment with chemotherapy or radiation
* Patients with a history of maxillofacial surgery
* Patients with select dental conditions like severe periodontal disease, temporomandibular joint disease, insufficient dentition to support appliance retention in the mouth
* Patients who use bone resorption inhibitors (such as bisphosphonates, calcitonin, SERMs) or the prolonged use, ≥ 6 months of corticosteroids

Primary outcomes:
measure: Dental occlusal measurements
timeFrame: Baseline; Year 1; Year 2; Year 3
measure: Molar and canine relationships
timeFrame: Baseline; Year 1; Year 2; Year 3
measure: History of orthodontic treatment
timeFrame: Baseline; Year 1; Year 2; Year 3
Secondary outcomes:
measure: Cephalometric dentofacial measurements
timeFrame: Baseline; Year 1; Year 2; Year 3
measure: Cephalometric facial and mandibular measurements
timeFrame: Baseline; Year 1; Year 2; Year 3
measure: Cephalometric ratios and divergence
timeFrame: Baseline; Year 1; Year 2; Year 3
Other outcomes:
measure: Quality of Life (QoL)
timeFrame: Baseline; Year 1; Year 2; Year 3
measure: Cognitive Function
timeFrame: Baseline; Year 1; Year 2; Year 3
measure: Sleep Quality
timeFrame: Baseline; Year 1; Year 2; Year 3
Locations:
Study officials:
affiliation: Amsterdam University Medical Center
name: J. de Lange, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam University Medical Center
name: J.P.T.F. Ho, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam University Medical Center
name: N.C.W. van der Kaaij, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Ruiter MHT, Aarab G, de Vries N, Lobbezoo F, de Lange J. A stepwise titration protocol for oral appliance therapy in positional obstructive sleep apnea patients: proof of concept. Sleep Breath. 2020 Sep;24(3):1229-1236. doi: 10.1007/s11325-020-02045-w. Epub 2020 Mar 11.