[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600934":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":61,"collaborators":65,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":25,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":25,"enrollmentInfo":79,"targetDuration":25,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":94,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"University of Kentucky","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Interocclusal Aligner","ACTIVE_COMPARATOR","Arm 1 (Interocclusal Aligner Group):\n\n\"Morning Interocclusal Aligner to Maintain Occlusion\" Participants in this arm will use a prefabricated thermoplastic device called the AM Aligner each morning immediately after removing their Mandibular Advancement Device (MAD). The aligner will be warmed and then gently bitten into for 2-5 minutes to help reposition the mandible and maintain the original occlusion. This approach is a standard-of-care method aimed at minimizing occlusal changes associated with MAD therapy.",[13],"Device: AM Aligner",{"label":15,"type":10,"description":16,"interventionNames":17},"Daily Jaw Exercises","Participants in this arm will be instructed to perform a standardized set of jaw exercises each morning after removing their MAD. The exercises include side-to-side jaw movements, backward pressure (such as the \"thinker's pose\"), and gentle simulated clenching.",[18],"Behavioral: Exercise",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","AM Aligner","Intervention Name: AM Aligner (Interocclusal Aligner) Type: Device Manufacturer: (AM Aligner; TAP Sleep Care, Texas, USA)\n\nDescription:\n\nThe AM Aligner is a prefabricated, commercially available thermoplastic appliance designed to help patients return their mandible to a normal resting position after nighttime use of a Mandibular Advancement Device (MAD). In this study, the aligner will be used each morning immediately after removing the MAD. The participant will bite into the warmed aligner for 2-5 minutes to promote realignment of the mandible and occlusion. This approach aims to minimize or prevent occlusal changes, including posterior open bite and anterior shift, associated with prolonged MAD therapy.\n\nThis intervention is distinct from the alternative study arm, which uses a set of guided jaw exercises instead of a physical appliance to achieve the same goal.\n\nThe AM Aligner used in this study is a standard-of-care option and is FDA-cleared for this use. It is not investigational.",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"BEHAVIORAL","Exercise","Participants in this arm will perform a standardized set of jaw exercises for 5 minutes each morning immediately after removing their Mandibular Advancement Device (MAD). The exercises are intended to assist in reestablishing the natural occlusal relationship following overnight mandibular advancement.\n\nThis routine includes the following movements:\n\nSide-to-side jaw movements Backward pressure to the chin (similar to a \"thinker's pose\") Gentle simulated clenching\n\nThe exercises are performed once daily and take approximately 2-3 minutes to complete. This approach represents a standard-of-care method for minimizing occlusal changes associated with MAD therapy.",[15],[32],{"name":33,"affiliation":5,"role":34},"Isable Moreno Hay, MS, PhD","STUDY_DIRECTOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Salma Habib, BDS","CONTACT","8593235500","skha265@uky.edu",{"name":42,"role":38,"phone":39,"phoneExt":25,"email":43},"Isabel Moreno Hay, MS, PhD","orofacialpain@uky.edu",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Orofacial Pain Center - University of Kentucky - Kentucky Clinic","RECRUITING","Lexington","Kentucky","40536","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-84.47772,37.98869,{"lat":57,"lon":56},[60],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Isabel Moreno Hay","Associate Professor",[66],{"name":67,"class":68},"American Academy of Orofacial Pain","UNKNOWN","100600934","ioa-preventing-occlusal-changes-with-mad-use-100600934",false,"NCT07103941","IOA Preventing Occlusal Changes With MAD Use","Effectiveness of Interocclusal Aligner (IOA) on Preventing Occlusal Changes in Patients Treated With a Mandibular Advancement Device (MAD): A Preliminary Study","Inclusion Criteria:\n\n* adult participants (≥18 years)\n* diagnosed with SRBD and prescribed Mandibular Advancement Device (MAD) therapy\n* Participants will include patients with well restored natural dentition with all posterior teeth, excluding third molars, one missing premolar secondary to orthodontic treatment.\n\nExclusion Criteria:\n\n* pervious orthognathic surgery\n* anterior cross bite\n* posterior cross bite\n* existing open bite or implant supported restorations\n* tooth mobility\n* significant dental caries or periodontitis\n* severe bruxism\n* planned upcoming dental work including caps, crowns, implants, or braces\n* inadequate mandibular protrusion\n* severe micrognathia\n* large tori\n* significant claustrophobia\n* significant nasal obstruction\n* large oropharyngeal masses or large tonsils",true,"ALL","18 Years",{"count":80,"type":81},30,"ESTIMATED","INTERVENTIONAL",[84],"NA","This study is evaluating two standard-of-care strategies used to prevent bite changes (occlusal changes) in patients treated with a Mandibular Advancement Device (MAD) for sleep-related breathing disorders such as obstructive sleep apnea (OSA). While MAD therapy is effective, it can lead to changes in how the teeth fit together, including the development of a posterior open bite.\n\nParticipants in this study will be randomly assigned to one of two standard-of-care approaches: using an interocclusal aligner each morning after removing the MAD, or performing daily jaw exercises. Both methods aim to reduce the risk of occlusal changes.\n\nThe study will follow participants over a 3-month period and includes dental evaluations, 3D oral scans, and short daily surveys. Findings from this research may help guide best practices for preserving occlusion during MAD therapy.",[87,88,89,90,91,92,93],"Sleep Related Breathing Disorder","Snoring","Obstructive Sleep Apnea (OSA)","Open Bite","Occlusal Changes","Tooth Migration","Posterior Open Bite",[9,95,93,91,96,97,98,99],"Mandibular advancement Device","Dental Changes","Protrusion","Sleep Appliance","Obstructive Sleep Apnea","2026-05-14",{"date":102,"type":103},"2026-05-18","ACTUAL",{"date":105,"type":103},"2025-11-17",{"date":107,"type":81},"2026-12-30",{"name":63,"class":6},1]