[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06636097":3,"trial-entities:NCT06636097":109,"trial-summary:NCT06636097":113},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":29,"interventions":32,"primary_outcomes":39,"secondary_outcomes":44,"sex":63,"minimum_age":64,"maximum_age":27,"healthy_volunteers":65,"eligibility_criteria":66,"std_ages":81,"locations":84,"central_contacts":94,"overall_officials":95,"references":100,"see_also_links":108},"NCT06636097","STUDY23100028","Intaglio Surface of Full-arch Implant Supported Prosthesis","Effect of the Intaglio Surface of Full-arch Implant-supported on Marginal Bone Level: A Cross-sectional Study","ENROLLING_BY_INVITATION","2027-12","2025-10","2025-10-10","2024-06-11","University of Pittsburgh","OTHER",false,"The purpose of the study is to determine if there is an association between the intaglio shape of full-arch implant-supported prosthesis and marginal bone level around implants. The intaglio shape can be present as concave or convex and, depending on that, it can lead to more plaque accumulation on the fitting surface of the prosthesis.\n\nNull Hypothesis (H0): Full-arch implant supported prosthesis with an increased depth of the intaglio shape demonstrate similar marginal bone levels as prosthesis with a reduced depth of the intaglio surface.\n\nAlternative Hypothesis (H1): Full-arch implant supported prosthesis with an increased depth of the intaglio shape demonstrate increased\u002Freduced marginal bone levels compared to prosthesis with a reduced depth of the intaglio surface.","The investigators will review dental records from the university and call eligible individuals for an appointment. During the research visit, the investigators will take new x-rays for marginal bone level assessment and a digital scan of the prosthesis to assess the shape of the intaglio. Also, remove the prosthesis, perform clinical measurements and collect plaque samples from the prosthesis and the implant sulcus. then, implants and prosthesis will be cleaned and placed in position.\n\nThe study will have only one appointment where every measurement will be assessed in this visit.",[19],"Peri-Implantitis",[21,22,23,24,25],"Peri-implantitis","Marginal Bone Level","Dental Implants","Full-arch Prosthesis","Hybrid prosthesis","OBSERVATIONAL",null,[],{"count":30,"type":31},50,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DEVICE","Full arch","design",[38],"Patients Rehabilitated with full-arch implant-supported prosthesis",[40],{"measure":41,"description":42,"timeFrame":43},"Evaluation of the depth of the shape of the intaglio surface of full-arch and its association with increased marginal bone level.","After the prosthesis is scanned, and evaluation of the 3D file of the prosthesis will occur. A virtual line will be traced between the Buccal to the Palatal\u002FLingual flange of the prosthesis. In the middle point of this line, a perpendicular line will be traced in direction of the fitting surface of the prosthesis, intaglio, and this distance will be measured in mm.","The measurements will be assessed during the unique visit of the patient in the study.",[45,48,51,54,57,60],{"measure":46,"description":47,"timeFrame":43},"Probing Depth of the implants","Using a periodontal probe we will register Probing Depth in 6 sites per implant. All measures will be in mm.",{"measure":49,"description":50,"timeFrame":43},"Bleeding on Probing of the implants","Using a periodontal probe we will register Bleeding in 6 sites using the bleeding indexes modified for dental implants.",{"measure":52,"description":53,"timeFrame":43},"Modified Plaque Index","Plaque accumulation will be evaluated using the modified plaque index adapted for dental implants.",{"measure":55,"description":56,"timeFrame":43},"Marginal Recession","The distance, in mm, between the implant platform and the mucosal margin.",{"measure":58,"description":59,"timeFrame":43},"Suppuration","Assessed by the presence\u002Fabsence of suppuration after gentle probing of the implants.",{"measure":61,"description":62,"timeFrame":43},"Keratinized mucosa width","Measured from the mucosal marginal level of the implants to the mucogingival junction. The band of keratinized mucosa will be characterized as narrow \\\u003C 2mm and wide \\> 2mm.","ALL","18 Years",true,{"inclusion":67,"exclusion":71,"raw_text":80},[68,69,70],"≥ 18 years old;","Rehabilitated with a full-arch screw-retained supported prosthesis in the maxilla, in function for at least 1 year;","Good overall health (ASA I or ASA II).",[72,73,74,75,76,77,78,79],"Individuals with motricity problems who cannot clean the prosthesis;","Patients treated or maintained in centers outside the University of Pittsburgh;","Incomplete dental records;","Misfit at the prosthesis-implant interface;","Cemented prosthesis;","Individuals rehabilitated with over dentures;","Individuals with uncontrolled chronic diseases or immunocompromised;","Pregnant Patients.","Inclusion Criteria:\n\n* ≥ 18 years old;\n* Rehabilitated with a full-arch screw-retained supported prosthesis in the maxilla, in function for at least 1 year;\n* Good overall health (ASA I or ASA II).\n\nExclusion Criteria:\n\n* Individuals with motricity problems who cannot clean the prosthesis;\n* Patients treated or maintained in centers outside the University of Pittsburgh;\n* Incomplete dental records;\n* Misfit at the prosthesis-implant interface;\n* Cemented prosthesis;\n* Individuals rehabilitated with over dentures;\n* Individuals with uncontrolled chronic diseases or immunocompromised;\n* Pregnant Patients.",[82,83],"ADULT","OLDER_ADULT",[85],{"facility":86,"city":87,"state":88,"zip":89,"country":90,"geoPoint":91},"University of Pittsburgh, School of Dental Medicine","Pittsburgh","Pennsylvania","15213","United States",{"lat":92,"lon":93},40.44062,-79.99589,[],[96],{"name":97,"affiliation":98,"role":99},"Andrea Ravida, DDS, MS, PhD","Program Director of the Periodontics and Implant Dentistry Department","PRINCIPAL_INVESTIGATOR",[101,105],{"pmid":102,"type":103,"citation":104},"3507627","RESULT","Mombelli A, van Oosten MA, Schurch E Jr, Land NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol. 1987 Dec;2(4):145-51. doi: 10.1111\u002Fj.1399-302x.1987.tb00298.x. No abstract available.",{"pmid":106,"type":103,"citation":107},"29926949","Araujo MG, Lindhe J. Peri-implant health. J Periodontol. 2018 Jun;89 Suppl 1:S249-S256. doi: 10.1002\u002FJPER.16-0424.",[],{"nct_id":4,"conditions":110,"biomarkers":112},[23,111],"Dental peri-implantitis",[],{"nct_id":4,"found":15,"summary":27,"prompt_version":27}]