Oral Dynamic Propulsion Appliance in Treatment of Patients With Obstructive Sleeping Apnea

Treatment Effects of Oral Dynamic Propulsion Appliance During the Sleeping Phase in Patients With Obstructive Sleeping Apnea

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Sleep Apnea (OSA)
• Intervention / Treatment: Device: dynamic propulsion oral appliance treatment (DPOA); Device: elastic mandibular advancement appliance treatment

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vojkan Lazić, DDS PhD, full professor; Phone Number: +381112685288; Email: stomfak@afrodita.rcub.bg.ac.rs

Study Locations

• Serbia
  • Belgrade, Serbia, 11000
    • University of Belgrade School of Dental Medicine
    • Principal Investigator: Marija S Milic, DDS PhD
    • Contact: Vojkan Lazic; Phone Number: +381112685288; Email: stomfak@afrodita.rcub.bg.ac.rs
    • Principal Investigator: Aleksandra Čairović
    • Principal Investigator: Luka Župac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 psychiatric, neurological or psychosomatic disorders
• patients with Body Mass Index > 29kg/sqm
• pregnancy
• presence of the anatomical obstruction in the airways
• severe periodontal disease (III and IV grade)
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: test group; patients treated with dynamic oral appliance	Device: dynamic propulsion oral appliance treatment (DPOA); application of dynamic propulsion oral appliance for the treatment of obstructive sleep apnea during the sleeping phase
Active Comparator: control; patients treated with Elastic Mandibular Advancement (EMA) appliance	Device: elastic mandibular advancement appliance treatment; treatment of obstructive sleep apnea with elastic mandibular advancement appliance during the sleeping phase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nasal airflow	measured by respiratory poligraphy (ml/min)	prior to treatment and 3 months after the treatment initiation
oxygen saturation	measured by respiratory poligraphy in the range 0-100%	prior to treatment and 3 months after start of the treatment
heart rate	measured by respiratory poligraphy in the range 30 - 250 bpm	prior to treatment and 3 months after treatment initiation
nasal air pressure	measured by respiratory poligraphy	prior to the treatment and 3 months after the treatment initiation
toracal and abdominal strain	measured by respiratory poligraphy	prior to the treatment and 3 months after treatment initiation
audio recording of breathing and snoring	measured by respiratory poligraphy	prior to the treatment and 3 months after treatment initiation
body posture and activity	measured by pulmonary poligraphy	prior to the treatment and 3 months after the treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sleepness monitoring	measured by Epworth Sleepness Scale (a self-administered, 8-question survey measuring daytime sleepiness by rating the likelihood of dozing in common, sedentary situations; scores range from 0-24, with higher numbers indicating excessive daytime sleepiness)	prior to the treatment and 3 months after the treatment initiation
snoring and breathing disruption during the sleep	measured by Berlin Questionnaire (snoring intensity, frequency, and witnessed apnea - questions Nr. 1 to Nr. 5, a positive score indicates a high risk of OSA	prior to the treatment and 3 months after the treatment initiation
daily sleepiness monitoring	measured by Berlin Questionnaire (daytime sleepiness, fatigue, or nodding off while driving - questions Nr. 6 to Nr. 9, positive score indicates high risk of OSA)	prior to the treatment and 3 months after the treatment initiation
presence of hypertension and/or obesity	measured by Berlin Questionnaire (History of high blood pressure (>140/90) or Body Mass Index (BMI) >30 kg/m2 - question 10)	prior to the treatment and 3 months after the treatment initiation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
jaw functional limitation skill	monitoring the movement range of the lower jaw	prior to the treatment and 3 months after the treatment initiation
masticatory muscles sensitivity	by the method of the palpation	prior to the treatment and 3 months after the treatment initiation
gingival index	according to the Lou-Silness	prior to the treatment and 3 months after the treatment initiation
plaque index	according to Silness-Lou	prior to the treatment and 3 months after the treatment initiation
bleeding on probing	based on the number of bleeding spots around each tooth	prior to the treatment and 3 months after the treatment initiation
probing pocket depth		prior to the treatment and 3 months after the treatment initiation

Collaborators and Investigators

• Sponsor: University of Belgrade
• Investigators: Principal Investigator: Marija S Milic, DDS PhD, University of Belgrade School of Dental Medicine; Principal Investigator: Aleksandra Čairović, DDS PhD, University of Belgrade School of Dental Medicine; Principal Investigator: Luka Župac, DDS, PhD student, University of Belgrade School of Dental Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: obstructive sleep apnea, oral apparatus
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 36/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study database with anonymised patient data is planned to be shared on the Zenodo or Figshare website

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No