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NCT Number: NCT07414420

Oral Dynamic Propulsion Appliance in Treatment of 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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Belgrade School of Dental Medicine

Belgrade, 11000, Serbia

Location contact

Aleksandra Čairović

PRINCIPAL_INVESTIGATOR

Luka Župac

PRINCIPAL_INVESTIGATOR

Marija S Milic, DDS PhD

PRINCIPAL_INVESTIGATOR

Vojkan Lazic

CONTACT

[email protected]

+381112685288

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dynamic propulsion oral appliance treatment (DPOA)

Device

application of dynamic propulsion oral appliance for the treatment of obstructive sleep apnea during the sleeping phase

elastic mandibular advancement appliance treatment

Device

treatment of obstructive sleep apnea with elastic mandibular advancement appliance during the sleeping phase

Primary outcomes

  1. nasal airflow

    Time frame: prior to treatment and 3 months after the treatment initiation

    measured by respiratory poligraphy (ml/min)

  2. oxygen saturation

    Time frame: prior to treatment and 3 months after start of the treatment

    measured by respiratory poligraphy in the range 0-100%

  3. heart rate

    Time frame: prior to treatment and 3 months after treatment initiation

    measured by respiratory poligraphy in the range 30 - 250 bpm

  4. nasal air pressure

    Time frame: prior to the treatment and 3 months after the treatment initiation

    measured by respiratory poligraphy

  5. toracal and abdominal strain

    Time frame: prior to the treatment and 3 months after treatment initiation

    measured by respiratory poligraphy

  6. audio recording of breathing and snoring

    Time frame: prior to the treatment and 3 months after treatment initiation

    measured by respiratory poligraphy

  7. body posture and activity

    Time frame: prior to the treatment and 3 months after the treatment initiation

    measured by pulmonary poligraphy

Secondary outcomes

  1. sleepness monitoring

    Time frame: prior to the treatment and 3 months after the treatment initiation

    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)

  2. snoring and breathing disruption during the sleep

    Time frame: prior to the treatment and 3 months after the treatment initiation

    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

  3. daily sleepiness monitoring

    Time frame: prior to the treatment and 3 months after the treatment initiation

    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)

  4. presence of hypertension and/or obesity

    Time frame: prior to the treatment and 3 months after the treatment initiation

    measured by Berlin Questionnaire (History of high blood pressure (>140/90) or Body Mass Index (BMI) >30 kg/m2 - question 10)

Other outcomes

  1. jaw functional limitation skill

    Time frame: prior to the treatment and 3 months after the treatment initiation

    monitoring the movement range of the lower jaw

  2. masticatory muscles sensitivity

    Time frame: prior to the treatment and 3 months after the treatment initiation

    by the method of the palpation

  3. gingival index

    Time frame: prior to the treatment and 3 months after the treatment initiation

    according to the Lou-Silness

  4. plaque index

    Time frame: prior to the treatment and 3 months after the treatment initiation

    according to Silness-Lou

  5. bleeding on probing

    Time frame: prior to the treatment and 3 months after the treatment initiation

    based on the number of bleeding spots around each tooth

  6. probing pocket depth

    Time frame: prior to the treatment and 3 months after the treatment initiation

Study contacts

Contact information is provided by the study sponsor or research team.

Vojkan Lazić, DDS PhD, full professor

CONTACT

[email protected]

+381112685288

Sponsors and collaborators

Lead sponsor

University of Belgrade

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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