Effectiveness of a Novel One visit 3D printing titratable Interlocking Mandibular Advancement Device for Mild to Moderate Obstructive Sleep Apnea

Effectiveness of a Novel One visit 3D printing titratable Interlocking Mandibular Advancement Device for Mild to Moderate Obstructive Sleep Apnea - Digital MAD for OSA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000056614

Enrollment

Registered

2025-01-02

Start date

2024-03-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild to moderate obstructive sleep apnea

Interventions

Novel fully digital designed MAD

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: New patient diagnosed with mild to moderate OSA (AHI 5-30 per hour), At least 8 sound teeth per arch, Maximum protrusion at least 5 mm., Position-related OSA, No previous surgical treatment of OSA, Withdrawing from CPAP treatment for a minimum of 14 days

Exclusion criteria

Exclusion criteria: History of allergy to polymer-based resin/polymer, Unstable health condition e.g. pregnant, regular use of narcotics, sedative, psychiatric disorders, Other sleep related breathing disorders e.g. central sleep apnea, sleep-related hypoventilation, and sleep-related hypoxemia disorder, Acute or chronic painful TMD, Craniofacial anomaly, Heavy sleep bruxism, Refuse to follow a study protocol

Design outcomes

Primary

Measure	Time frame
The newly designed digital interlocking MAD presents a promising alternative for managing mild to moderate OSA treatment.	—

Secondary

Measure	Time frame
The newly designed digital interlocking MAD offers acceptable effectiveness, reduced waiting times and lower costs.	—

Countries

Asia(except Japan)

Contacts

Public ContactAsst. Prof. Dr. Supanigar Ruangsri

Faculty of Dentistry, Khon Kaen University, Thailand Division of oral biology

suprua@kku.ac.th66894224845

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026