[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648220":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":42,"responsibleParty":58,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":25,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":84,"overallStatus":87,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequence B","EXPERIMENTAL","Participants receive a CAD\u002FCAM occlusal splint fabricated using a virtual increase of the vertical dimension (without a wax bite registration) for 3 weeks, followed by a CAD\u002FCAM occlusal splint fabricated using a conventional wax bite registration for 3 weeks.",[13,14],"Device: Occlusal splint fabricated using a virtual increase of the vertical dimension","Device: Occlusal splint fabricated using a conventional wax bite registration",{"label":16,"type":10,"description":17,"interventionNames":18},"Sequence A","Participants receive a CAD\u002FCAM occlusal splint fabricated using a conventional wax bite registration for 3 weeks, followed by a CAD\u002FCAM occlusal splint fabricated using a virtual increase of the vertical dimension (without a wax bite registration) for 3 weeks.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Occlusal splint fabricated using a virtual increase of the vertical dimension","Intervention 1: CAD\u002FCAM occlusal splint fabricated using a virtual increase of the vertical dimension CAD\u002FCAM-milled occlusal splint fabricated from PMMA using a fully digital workflow. The splint is designed by virtually increasing the vertical dimension based on the participant's maximal intercuspation, without the use of a conventional wax bite registration. Participants will wear the splint overnight for 3 weeks (minimum 6 hours per night).",[16,9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Occlusal splint fabricated using a conventional wax bite registration","Intervention 2: CAD\u002FCAM occlusal splint fabricated using a conventional wax bite registration CAD\u002FCAM-milled occlusal splint fabricated from the same PMMA material using a conventional wax bite registration to determine the vertical dimension and occlusal relationship during the digital design process. Participants will wear the splint overnight for 3 weeks (minimum 6 hours per night).",[16,9],[31],{"name":32,"affiliation":5,"role":33},"Sabine Mechelse, MSc","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","0031648136263","sabine.mechelse@radboudumc.nl",{"name":40,"role":36,"phone":25,"phoneExt":25,"email":41},"Stanimira Kalaykova-Sparreboom, dr.","stanimira.kalaykova@radboudumc.nl",[43],{"facility":44,"status":25,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RadboudUMC","Nijmegen","Gelderland","6525EX","Netherlands","NL",{"type":51,"coordinates":52},"Point",[53,54],5.85278,51.8425,{"lat":54,"lon":53},[57],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},{"type":59,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100648220","clinical-performance-of-cadcam-occlusal-splints-fabricated-with-or-without-a-wax-bite-registration-in-healthy-adults-100648220",false,"NCT07720453","Clinical Performance of CAD\u002FCAM Occlusal Splints Fabricated With or Without a Wax Bite Registration in Healthy Adults","Clinical Performance of CAD\u002FCAM Occlusal Splints Fabricated With or Without Wax Bite Registration: A Randomized Crossover Clinical Trial","Splint","Inclusion criteria:\n\n* Subjects aged 18-45 years\n* Subjects with an ASA physical status classification of I-III.\n* Subjects with healthy complete dentitions (except for congenitally missing teeth (agenesis), extractions of wisdom teeth, or tooth extractions for the purpose of orthodontic treatment in the past)\n* Subjects willing and able to participate in the study\n* Subjects willing to provide written informed consent for their participation in the study\n\nExclusion Criteria:\n\n* Subjects presenting with active dental disease, extensive restorations affecting the occlusion, or other oral conditions that may interfere with the assessment of the occlusal splints\n* Subjects with a history of autoimmune disorders\n* Subjects with known allergies to acrylic materials\n* Subjects with severe allergies manifested by a history of anaphylaxis or those with severe, chronic allergies (e.g., asthma) and subjects with an active infection of any kind at the time of enrollment\n* Subjects who are pregnant or lactating\n* Subjects enrolled in another investigational clinical trial",true,"ALL","18 Years","45 Years",{"count":73,"type":74},30,"ESTIMATED","INTERVENTIONAL",[77],"NA","Occlusal splints are commonly used to manage sleep bruxism, temporomandibular disorders, and tooth wear. Traditionally, a wax bite registration is used during the fabrication of CAD\u002FCAM occlusal splints to determine the vertical dimension and occlusal relationship. New digital techniques allow the splint to be designed without a wax bite registration by virtually increasing the vertical dimension based on maximal intercuspation.\n\nThis randomized crossover study compares these two fabrication workflows in healthy volunteers. Participants will wear both splints in random order. The study will evaluate patient-reported comfort and clinical performance, including occlusal contacts, force distribution, splint stability, and the occlusal adjustments required during insertion",[80,81,82,83],"Occlusion","Occlusal Splints","Occlusal Analysis","Comfort",[85,86],"Milled splints","Prospective clinical randomized crossover study","NOT_YET_RECRUITING","2026-07-24",{"date":90,"type":91},"2026-07-27","ACTUAL",{"date":93,"type":74},"2026-09-01",{"date":95,"type":74},"2027-01-31",{"name":5,"class":6},1]