Oral Dynamic Propulsion Appliance in Treatment of Patients With Obstructive Sleeping Apnea
Key facts
- Who runs it
- University of Belgrade
- Where
- Belgrade, SerbiaSee the site
- Trial code
- Status
- Not yet recruiting
- People taking part
- 40 people, planned
- Started
- Mar 2026
- Expected to end
- Sept 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- dynamic propulsion oral appliance treatment (DPOA)
- elastic mandibular advancement appliance treatment
- Record updated
- 18 February 2026
Who can take part
- Age
- 20 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- age between 20 and 65 years
- clinically confirmed diagnosis of mild or moderate obstructive sleep apnea (Apnea hypopnea index 15-30 episodes/hour)
- sufficient number of periodontally healthy teeth to support the oral appliance
- written informed consent of conformance with the study protocol
Who cannot take part
- patients with psychiatric, neurological or psychosomatic disorders
- severe periodontal disease (III and IV grade)
- age bellow 20 and over 65 years
- patients not able or not willing to follow the study protocol
- patients with severe OSA (Apnea hypopnea index > 30 episodes/hour) and/or some other breathing disturbances
- patients with Body Mass Index > 29kg/sqm
- pregnancy
- presence of the anatomical obstruction in the airways
- pathological changes in the structures of TMJ, muscles or ligaments
- mandibular protrusion less than 3mm
- orthodontic anomalies, malocclusions, II and III skeletal class, and orthodontic appliances
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 65 years old?
Where in Serbia
- University of Belgrade School of Dental MedicineBelgrade, SerbiaContact: Vojkan LazicNo longer taking part
About the trial
What the trial wants to find out
Obstructive Sleep Apnea (OSA) is one of the most prevalent sleep disorders, affecting nearly one billion people worldwide. It is characterized by repeated episodes of complete (apnea) or partial (hypopnea) obstruction of the upper airway during sleep, leading to snoring, excessive daytime sleepiness, insomnia, morning headaches, nocturia, behavioral changes, reduced concentration, and serious cardiovascular and metabolic complications such as insulin resistance, type II diabetes, and metabolic syndrome. During the night, patients may experience up to a hundred apnea or hypopnea events lasting from 10 to 120 seconds. Therapy for OSA depends on its severity, defined by five or more obstructive events per hour of sleep. Over the past decade and a half, oral appliances (OAs) have become the treatment of choice for mild to moderate forms of OSA due to their efficacy and comfort. For this purpose, the DYNAMIC PROPULSION ORAL APPLIANCE (DPOA) has been designed with a mechanism that provides controlled, gentle, gradual and automatic mandible movement in propulsion during sleep. Unlike conventional OAs that fix the mandible in only one propulsive position, causing stress to orofacial complex and upper airway structures such as masticatory muscles and the temporomandibular joints, the DPOA provides gradual, automatic mandibular movement to the previously determined propulsive position. This gradual adaptation minimizes stress, reduces side effects, and enhances treatment success. In that way, the DPOA enables complete functional adaptation of the orofacial system and upper airway structures, leading to improved patient comfort and better therapeutic outcome.
Read full original descriptionShow less
The primary objective of the study is to determine the effectiveness of OSA therapy in patients with skeletal Class I (eugnathic jaw relationship) using a DYNAMIC PROPULSION ORAL APPLIANCE (DPOA) with a mechanism that provides controlled, gentle, gradual and automatic mandible movement in propulsion during sleep.
The 2 groups in the trial
- test groupTreatment being tested
patients treated with dynamic oral appliance
Treatment: dynamic propulsion oral appliance treatment (DPOA)
- controlExisting treatment, for comparison
patients treated with Elastic Mandibular Advancement (EMA) appliance
Treatment: elastic mandibular advancement appliance treatment
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Treatment Effects of Oral Dynamic Propulsion Appliance During the Sleeping Phase in Patients With Obstructive Sleeping Apnea
- Fit questions
- Built from NCT07414420, who can take part
- Record updated
- 18 February 2026