Superimposition of Intra-oral Scans in MAD Therapy for OSA

NCT06612008 | Not Yet Recruiting

• 1 other identifier: 202401
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

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. 1.To track dental and jaw changes in OSA patients using 3D scans.
2. 2.To assess the impact of MAD on quality of life and cognitive function.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea; Obstructive Sleep Apnea Syndrome; Oral Appliance Therapy; Mandibular Advancement Device

Outcome Measures

Primary Outcomes (3)

• Dental occlusal measurements

  * Overbite (mm): the vertical overlap of the upper and lower teeth. * Overjet (mm): the horizontal overlap of the upper and lower teeth. * Maximal protrusion (mm): the most protrusive position of the mandible, independent of tooth contact. * Maximal retrusion (mm): the most retrusive position of the mandible, independent of tooth contact. * Protrusive range (mm): the distance between the most protrusive and most retrusive position of the mandible. * Maximal mouth opening (mm): the maximum distance between the upper and lower incisors when the mouth is fully opened.

  Baseline; Year 1; Year 2; Year 3

• Molar and canine relationships

  * Molar relationships (in premolar width equivalents): the relative position of the upper and lower molars. * Canine relationships (in premolar width equivalents): the relative position of the upper and lower canines.

  Baseline; Year 1; Year 2; Year 3

• History of orthodontic treatment

  • Previous orthodontic treatment (braces/ premolar extractions)

  Baseline; Year 1; Year 2; Year 3

Secondary Outcomes (3)

• Cephalometric dentofacial measurements

  Baseline; Year 1; Year 2; Year 3

• Cephalometric facial and mandibular measurements

  Baseline; Year 1; Year 2; Year 3

• Cephalometric ratios and divergence

  Baseline; Year 1; Year 2; Year 3

Other Outcomes (3)

• Quality of Life (QoL)

  Baseline; Year 1; Year 2; Year 3

• Cognitive Function

  Baseline; Year 1; Year 2; Year 3

• Sleep Quality

  Baseline; Year 1; Year 2; Year 3

Study Arms (2)

Stepwise titration

Patients will receive a MAD with an individualized stepwise titration protocol. Initially, the device is set at 60% advancement of the maximum protrusion. Over the first 3 months, the advancement is adjusted incrementally (to 75% or 90%) based on subjective improvement in OSA symptoms and side effects. If side effects occur, the advancement is decreased.

Device: Mandibular Advancement Device

Personalized titration

Patients will receive a MAD set to baseline settings. Instead of following a standard titration process, personalized titration will use both objective data and subjective patient feedback to determine the optimal advancement. This approach takes into account individual factors such as the patient's oral anatomy, sleep study results, and specific symptoms. The goal is to achieve a personalized, optimal setting that maximizes symptom improvement and comfort.

Device: Mandibular Advancement Device

Interventions

Mandibular Advancement Device 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.

Personalized titration; Stepwise titration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Academic Centre for Dentistry in Amsterdam: collaborator

Related Publications (1)

• 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.

  PMID: 32162278 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• J. de Lange, Prof. Dr.

  Amsterdam University Medical Center

  PRINCIPAL INVESTIGATOR

• J.P.T.F. Ho, Dr.

  Amsterdam University Medical Center

  PRINCIPAL INVESTIGATOR

• N.C.W. van der Kaaij, Dr.

  Amsterdam University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

A. el Khalfioui, Bsc

CONTACT

0684900593; a.elkhalfioui@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 25, 2024
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share