[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626291":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":28,"studyPopulation":18,"armGroups":29,"interventions":42,"overallOfficials":56,"centralContacts":61,"locations":66,"responsibleParty":80,"collaborators":18,"id":84,"slug":18,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":18,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":68,"whyStopped":18,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Baskent University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Splint wear (volumetric material loss)","Volumetric material loss of the occlusal splint (mm³) over 3 months. Each splint will be 3D scanned at baseline (after delivery) and at the 3-month follow-up. Baseline and follow-up scans will be aligned using a standardized superimposition procedure, and the volume difference will be calculated to quantify wear.","3 months",[14],{"measure":15,"description":16,"timeFrame":17},"Patient-reported satisfaction and oral health-related quality of life (OHIP-derived questionnaire)","Patient-reported outcomes will be assessed using an OHIP-derived questionnaire. The questionnaire will be completed at baseline and at the 3-month follow-up; the change in total score (and\u002For domain scores, if applicable) will be analyzed to compare groups.","Baseline and 3 months",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":24,"maskingDescription":25,"whoMasked":26},"SINGLE","Participants and treating clinicians are not blinded due to the nature of the interventions. Volumetric wear analysis based on 3D scans is performed by an outcome assessor blinded to group allocation.",[27],"OUTCOMES_ASSESSOR","Occlusal splints are commonly used to manage symptoms associated with bruxism. With the growing adoption of digital workflows, 3D-printed splints have become an alternative to conventional acrylic splints; however, evidence comparing patient-centered outcomes and clinical durability between these approaches remains limited. This study is designed to compare a 3D-printed photopolymer-based occlusal splint (Voco V-Print) with a conventionally fabricated acrylic occlusal splint in adults diagnosed with bruxism.\n\nIn this randomized clinical study, eligible participants will be assigned to one of two splint fabrication approaches. All participants will receive a custom-made occlusal splint delivered according to standardized clinical procedures and will be instructed to wear the splint during sleep for approximately three months, following standardized use and care instructions. Follow-up assessments will be performed at the end of the study period to capture patient-reported outcomes and clinical performance.\n\nPatient-reported satisfaction and oral health-related quality of life will be evaluated using an OHIP-derived questionnaire administered at the follow-up visit. Clinical durability will be assessed by quantifying splint wear as volumetric material loss. For this purpose, each splint will be digitized by 3D scanning at baseline (after fabrication\u002Fdelivery) and again at follow-up. The two scans will be aligned using a standardized superimposition procedure, and volumetric loss (mm³) will be calculated to quantify wear. The study will provide comparative data on whether 3D-printed splints offer similar patient experience and material performance to conventional acrylic splints over a short-term clinical use period.",[30,37],{"label":31,"type":32,"description":33,"interventionNames":34},"3D-Printed Occlusal Splint (Voco V-Print)","EXPERIMENTAL","Participants will receive a custom-made occlusal splint fabricated by 3D printing using a photopolymer resin (Voco V-Print) following a standardized clinical workflow. The splint will be delivered and adjusted as needed and worn during sleep for 3 months.",[35,36],"Device: 3D-Printed Occlusal Splint (Voco V-Print)","Device: Conventional Acrylic Occlusal Splint",{"label":38,"type":39,"description":40,"interventionNames":41},"Conventional Acrylic Occlusal Splint","ACTIVE_COMPARATOR","Participants will receive a custom-made conventional occlusal splint fabricated from acrylic resin using standard laboratory techniques. The splint will be delivered and adjusted as needed and worn during sleep for 3 months.",[35,36],[43,51],{"type":44,"name":31,"description":45,"armGroupLabels":46,"otherNames":47},"DEVICE","Custom-made occlusal splint manufactured by 3D printing using a photopolymer resin (Voco V-Print) and delivered with standardized instructions for use and care. Worn during sleep for 3 months.",[31,38],[48,49,50],"Occlusal Splint","Stabilization Splint","Michigan Splint",{"type":44,"name":38,"description":52,"armGroupLabels":53,"otherNames":54},"Custom-made conventional acrylic occlusal splint fabricated using standard techniques and delivered with standardized instructions for use and care. Worn during sleep for 3 months.",[31,38],[55,50],"Stabilization splint",[57],{"name":58,"affiliation":59,"role":60},"Hale Arıkan Kalaycı, Assistant Professor","Başkent University, Faculty of Dentistry","STUDY_DIRECTOR",[62],{"name":58,"role":63,"phone":64,"phoneExt":18,"email":65},"CONTACT","+903122466666","halearikan@baskent.edu.tr",[67],{"facility":59,"status":68,"city":69,"state":18,"zip":70,"country":71,"countryCode":18,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"RECRUITING","Ankara","06490","Turkey (Türkiye)",{"type":73,"coordinates":74},"Point",[75,76],32.85427,39.91987,{"lat":76,"lon":75},[79],{"name":58,"role":63,"phone":64,"phoneExt":18,"email":65},{"type":81,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Hale Arıkan Kalaycı","Assistant Professor","100626291",false,"NCT07433725","3D-Printed vs Conventional Acrylic Stabilization Splints in Young Adults With Bruxism and Temporomandibular Disorders: A Randomized Trial","Clinical Performance of Stabilization Splints Produced With a 3D Printer in the Treatment of Bruxism and Temporomandibular Disorders","3D PRINTED","Inclusion Criteria:\n\n* Adults (≥18 years) diagnosed with bruxism (sleep and\u002For awake bruxism) based on clinical assessment and patient report.\n\nIndication for an occlusal splint and willingness to wear the splint during sleep for 3 months.\n\nAbility to provide written informed consent and to attend scheduled follow-up visits.\n\nExclusion Criteria:\n\n* Current or recent use of an occlusal splint within the last 6 months.\n\nOngoing orthodontic treatment or planned major dental treatment during the study period that could affect occlusion.\n\nSevere temporomandibular disorder requiring active treatment (e.g., acute pain, limited mouth opening) or other conditions that could contraindicate splint use.\n\nExtensive untreated dental disease requiring immediate care (e.g., severe periodontal disease, multiple untreated caries).\n\nSystemic\u002Fneurologic conditions or medications that may significantly affect bruxism or neuromuscular function (as judged by the investigator).","ALL","18 Years","25 Years",{"count":95,"type":96},44,"ESTIMATED","INTERVENTIONAL",[99],"NA","This randomized clinical study will compare two occlusal splint (night guard) fabrication methods in adults with bruxism (teeth grinding\u002Fclenching). Forty-four participants will be randomly allocated to receive either (1) a 3D-printed splint manufactured from a photopolymer resin (Voco V-Print) or (2) a conventional acrylic splint fabricated using standard techniques. Participants will wear the splint during sleep for 3 months and will follow standardized instructions for use and care. At the 3-month follow-up, patient-reported satisfaction and oral health-related quality of life will be assessed using an OHIP-derived questionnaire, and splint wear will be quantified as volumetric material loss (mm³) by 3D scanning and superimposition. The results will help determine whether 3D-printed splints provide comparable patient-centered outcomes and clinical durability to conventional acrylic splints.",[102],"Bruxism, Sleep",[104],"occlusal splint","2026-02-19",{"date":107,"type":108},"2026-02-25","ACTUAL",{"date":110,"type":108},"2026-01-12",{"date":112,"type":96},"2026-08",{"name":5,"class":6},1]