[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624806":3},{"organization":4,"outcomesModule":7,"designInfo":65,"detailedDescription":64,"studyPopulation":64,"armGroups":74,"interventions":87,"overallOfficials":97,"centralContacts":107,"locations":113,"responsibleParty":133,"collaborators":64,"id":136,"slug":64,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":64,"eligibilityCriteria":141,"healthyVolunteers":137,"sex":142,"minAge":143,"maxAge":144,"enrollmentInfo":145,"targetDuration":64,"studyType":148,"phases":149,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":156,"whyStopped":64,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"University of Belgrade","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":33,"otherOutcomes":46},[9,13,17,21,25,28,30],{"measure":10,"description":11,"timeFrame":12},"nasal airflow","measured by respiratory poligraphy (ml\u002Fmin)","prior to treatment and 3 months after the treatment initiation",{"measure":14,"description":15,"timeFrame":16},"oxygen saturation","measured by respiratory poligraphy in the range 0-100%","prior to treatment and 3 months after start of the treatment",{"measure":18,"description":19,"timeFrame":20},"heart rate","measured by respiratory poligraphy in the range 30 - 250 bpm","prior to treatment and 3 months after treatment initiation",{"measure":22,"description":23,"timeFrame":24},"nasal air pressure","measured by respiratory poligraphy","prior to the treatment and 3 months after the treatment initiation",{"measure":26,"description":23,"timeFrame":27},"toracal and abdominal strain","prior to the treatment and 3 months after treatment initiation",{"measure":29,"description":23,"timeFrame":27},"audio recording of breathing and snoring",{"measure":31,"description":32,"timeFrame":24},"body posture and activity","measured by pulmonary poligraphy",[34,37,40,43],{"measure":35,"description":36,"timeFrame":24},"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)",{"measure":38,"description":39,"timeFrame":24},"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",{"measure":41,"description":42,"timeFrame":24},"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)",{"measure":44,"description":45,"timeFrame":24},"presence of hypertension and\u002For obesity","measured by Berlin Questionnaire (History of high blood pressure (\\>140\u002F90) or Body Mass Index (BMI) \\>30 kg\u002Fm2 - question 10)",[47,50,53,56,59,62],{"measure":48,"description":49,"timeFrame":24},"jaw functional limitation skill","monitoring the movement range of the lower jaw",{"measure":51,"description":52,"timeFrame":24},"masticatory muscles sensitivity","by the method of the palpation",{"measure":54,"description":55,"timeFrame":24},"gingival index","according to the Lou-Silness",{"measure":57,"description":58,"timeFrame":24},"plaque index","according to Silness-Lou",{"measure":60,"description":61,"timeFrame":24},"bleeding on probing","based on the number of bleeding spots around each tooth",{"measure":63,"description":64,"timeFrame":24},"probing pocket depth",null,{"allocation":66,"interventionModel":67,"interventionModelDescription":64,"primaryPurpose":68,"observationalModel":64,"timePerspective":64,"maskingInfo":69},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":70,"maskingDescription":64,"whoMasked":71},"DOUBLE",[72,73],"PARTICIPANT","OUTCOMES_ASSESSOR",[75,81],{"label":76,"type":77,"description":78,"interventionNames":79},"test group","EXPERIMENTAL","patients treated with dynamic oral appliance",[80],"Device: dynamic propulsion oral appliance treatment (DPOA)",{"label":82,"type":83,"description":84,"interventionNames":85},"control","ACTIVE_COMPARATOR","patients treated with Elastic Mandibular Advancement (EMA) appliance",[86],"Device: elastic mandibular advancement appliance treatment",[88,93],{"type":89,"name":90,"description":91,"armGroupLabels":92,"otherNames":64},"DEVICE","dynamic propulsion oral appliance treatment (DPOA)","application of dynamic propulsion oral appliance for the treatment of obstructive sleep apnea during the sleeping phase",[76],{"type":89,"name":94,"description":95,"armGroupLabels":96,"otherNames":64},"elastic mandibular advancement appliance treatment","treatment of obstructive sleep apnea with elastic mandibular advancement appliance during the sleeping phase",[82],[98,102,105],{"name":99,"affiliation":100,"role":101},"Aleksandra Čairović, DDS PhD","University of Belgrade School of Dental Medicine","PRINCIPAL_INVESTIGATOR",{"name":103,"affiliation":104,"role":101},"Luka Župac, DDS, PhD student","University of Belgrade School of dental Medicine",{"name":106,"affiliation":100,"role":101},"Marija S Milic, DDS PhD",[108],{"name":109,"role":110,"phone":111,"phoneExt":64,"email":112},"Vojkan Lazić, DDS PhD, full professor","CONTACT","+381112685288","stomfak@afrodita.rcub.bg.ac.rs",[114],{"facility":100,"status":64,"city":115,"state":64,"zip":116,"country":117,"countryCode":118,"cosmosGeoPoint":119,"geoPoint":124,"contacts":125},"Belgrade","11000","Serbia","RS",{"type":120,"coordinates":121},"Point",[122,123],20.46513,44.80401,{"lat":123,"lon":122},[126,128,130,132],{"name":127,"role":110,"phone":111,"phoneExt":64,"email":112},"Vojkan Lazic",{"name":129,"role":101,"phone":64,"phoneExt":64,"email":64},"Aleksandra Čairović",{"name":131,"role":101,"phone":64,"phoneExt":64,"email":64},"Luka Župac",{"name":106,"role":101,"phone":64,"phoneExt":64,"email":64},{"type":101,"investigatorFullName":134,"investigatorTitle":135,"investigatorAffiliation":5,"oldNameTitle":64,"oldOrganization":64},"Marija S. Milic","DDS PhD, Assistant Professor","100624806",false,"NCT07414420","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","Inclusion Criteria:\n\n* age between 20 and 65 years\n* clinically confirmed diagnosis of mild or moderate obstructive sleep apnea (Apnea hypopnea index 15-30 episodes\u002Fhour)\n* sufficient number of periodontally healthy teeth to support the oral appliance\n* written informed consent of conformance with the study protocol\n\nExclusion Criteria:\n\n* age bellow 20 and over 65 years\n* patients not able or not willing to follow the study protocol\n* patients with severe OSA (Apnea hypopnea index \\> 30 episodes\u002Fhour) and\u002For some other breathing disturbances\n* patients with psychiatric, neurological or psychosomatic disorders\n* patients with Body Mass Index \\> 29kg\u002Fsqm\n* pregnancy\n* presence of the anatomical obstruction in the airways\n* severe periodontal disease (III and IV grade)\n* pathological changes in the structures of TMJ, muscles or ligaments\n* mandibular protrusion less than 3mm\n* orthodontic anomalies, malocclusions, II and III skeletal class, and orthodontic appliances","ALL","20 Years","65 Years",{"count":146,"type":147},40,"ESTIMATED","INTERVENTIONAL",[150],"NA","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.\n\nThe 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.",[153],"Obstructive Sleep Apnea (OSA)",[155],"obstructive sleep apnea, oral apparatus","NOT_YET_RECRUITING","2026-02-13",{"date":159,"type":160},"2026-02-18","ACTUAL",{"date":162,"type":147},"2026-03",{"date":164,"type":147},"2027-09",{"name":5,"class":6},1]