[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"clinical-assessment\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:clinical-assessment":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100607949","clinical-evaluation-of-additive-and-subtractive-onlay-restorations-100607949",false,"NCT07195201","Clinical Evaluation of Additive and Subtractive Onlay Restorations","Prospective Evaluation of Onlay Restorations Produced by Additive and Subtractive Manufacturing in Vital Posterior Teeth: A Split-Mouth","CIP-ONLAY","Inclusion Criteria:\n\nParticipant-Level Criteria\n\n* Adults aged 18-84 years\n* No active periodontal disease (probing depth ≤ 3 mm, no clinical attachment loss)\n* No parafunctional habits such as bruxism, clenching, or foreign object chewing\n* Willingness to attend regular follow-up visits during the study period\n* Adequate oral hygiene status\n* No history of systemic disease or medically stable condition if present\n* No history of similar restorative procedures involving the target teeth Tooth-Level Criteria\n* Vital posterior teeth (premolars or molars) confirmed by thermal or electric pulp testing; teeth requiring endodontic treatment or with necrosis will be excluded\n* Permanent posterior teeth located in functional occlusion (premolar or molar region)\n* Teeth with moderate structural loss suitable for onlay restorations, including mesio-occlusal (MO), disto-occlusal (DO), or mesio-occluso-distal (MOD) cavities with partial crown loss but sufficient remaining tooth structure not requiring full coverage\n* Periodontally healthy teeth with no mobility, no clinical attachment loss, and probing depth ≤ 3 mm\n* Teeth that can be matched in contralateral quadrants to allow split-mouth design (structurally and clinically comparable teeth)\n* Teeth free from cracks, fractures, or internal resorption; supporting tissues without structural defects that may compromise restoration success\n* Teeth with clearly defined preparation margins located in enamel or sound dentin; subgingival margins extending deep into the sulcus will not be included\n* Teeth without previous extensive prosthetic restorations (crowns, inlays\u002Fonlays, or implant-supported restorations)\n* Opposing natural teeth in stable occlusal contact with the restored tooth\n\nExclusion Criteria:\n\n* Teeth with pulp necrosis or a history of endodontic treatment (previous root canal therapy or non-vital teeth)\n* Teeth with excessive tissue loss requiring full crown coverage and unsuitable for onlay restoration\n* Teeth presenting with cracks, fractures, internal or external resorption, or structural defects compromising prognosis\n* Advanced periodontal disease, including clinical attachment loss, furcation involvement, mobility, or probing depth \\> 3 mm\n* Teeth with subgingival cavity margins extending deep into the gingival sulcus, increasing periodontal risk\n* Teeth with a history of fixed prosthetic restorations (previous crowns, inlays\u002Fonlays, or bridge restorations)\n* Teeth lacking proximal contacts due to adjacent tooth absence, leading to compromised contact stability and occlusal load distribution\n* Teeth in regions with orthodontic appliances or fixed retainers that may interfere with restorative procedures or evaluation\n* Opposing teeth absent or lacking stable occlusal contact with the restoration site\n* Patients with systemic diseases contraindicate elective dental treatment (e.g., uncontrolled diabetes, immunocompromised status)\n* Pregnant or breastfeeding women\n* Patients unable or unwilling to attend scheduled follow-up visits \\[baseline (1 week), 6 months, 12 months, and 18 months\\]","ALL","18 Years","84 Years",{"count":21,"type":22},29,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to learn whether onlay restorations produced by additive manufacturing \\[three-dimensional (3D) printing\\] and subtractive manufacturing \\[Computer-Aided Design\u002FComputer-Aided Manufacturing (CAD\u002FCAM) milling\\] perform equally well in vital posterior teeth. The main questions it aims to answer are:\n\n* Do 3D printed onlay restorations show similar marginal adaptation and clinical performance compared to CAD\u002FCAM milled onlays?\n* Are there any differences in biological compatibility, surface properties, or postoperative sensitivity between the two techniques over time? Researchers will compare onlay restorations fabricated with 3D printing and CAD\u002FCAM milling using a split-mouth study design.\n\nParticipants will:\n\n* Receive one onlay restoration produced by 3D printing and another produced by CAD\u002FCAM milling, placed on opposite sides of the mouth\n* Have checkups at baseline (1st week), 6 months, 12 months, and 18 months after treatment\n* Be evaluated using the Fédération Dentaire Internationale (FDI) criteria for marginal adaptation, surface quality, anatomical form, and biological compatibility",[28,29,30,31],"CAD-CAM","Prospective Study","3D Printing","Clinical Assessment",[33,34,35,36,37],"onlay restorations","cad-cam","additive manufacturing","3D printing","FDI criteria","NOT_YET_RECRUITING","2025-09-23",{"date":41,"type":42},"2025-09-26","ACTUAL",{"date":44,"type":22},"2025-11-15",{"date":46,"type":22},"2027-08-31",{"name":48,"class":49},"Ayse Tugba Erturk Avunduk","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":5},"100607887","contactless-optical-monitoring-of-av-access-using-the-patensee-system-in-outpatient-hemodialysis-patients-100607887","NCT07194395","Contactless Optical Monitoring of AV Access Using the PatenSee System in Outpatient Hemodialysis Patients","A Prospective International Multicenter, Non-Interventional, Single Arm, Blinded Feasibility Study to Assess the Contactless Optical Monitoring of AV Access Using the PatenSee System in Dialysis Patients","Inclusion Criteria:\n\n1. Male and female adult patient aged ≥18 years old\n2. Patient has a non-reversible kidney failure that requires long-term hemodialysis\n3. Patient has a functioning AV access (AVF\u002FG) in the upper extremity\n4. Patient is able and willing to provide consent by signing an EC\u002FIRB approved informed consent form\n5. Patient is willing and able to follow the requirements of the study\n\nExclusion Criteria:\n\n1. An active AV access infection\n2. An AV access condition that will likely require revision, e.g., symptomatic steal syndrome\n3. Expected to recover kidney function, receive a kidney transplant, transfer to peritoneal dialysis (PD) or transfer to non-study site during the study period.\n4. Any reason per investigator's discretion for which the patient is not suitable for the study\n5. Any medical or psychiatric illness, which in the opinion of the investigator would compromise the patient's ability to adhere to study requirements\n6. Previous participation in an interventional study within 30 days prior to study enrollment that may interfere with evaluation of the study endpoints\n7. Female patient is pregnant or breastfeeding",{"count":59,"type":22},90,"OBSERVATIONAL","This is a prospective, non-interventional, single arm, international multicenter study in which up to 120 adult participants with kidney failure requiring regular hemodialysis through arteriovenous (AV) access (AV fistula or graft) will be recruited and evaluated using the PatenSee system.\n\nData captured on the PatenSee system will be analyzed and evaluated against standard of care clinical monitoring of AV accesses.",[63,31],"Hemodialysis",[65,66,67,68,69],"Nephrology","AV access","Clinical monitoring of AV access","Fistula","AV graft","RECRUITING","2025-09-18",{"date":41,"type":42},{"date":74,"type":42},"2025-06-06",{"date":76,"type":22},"2027-02-28",{"name":78,"class":79},"PatenSee Ltd.","INDUSTRY"]