[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648842":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":41,"locations":51,"responsibleParty":82,"collaborators":85,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":45,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":118,"overallStatus":125,"whyStopped":45,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"University of Illinois at Chicago","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AHA Group","EXPERIMENTAL","Participants assigned to the experimental group will receive a prefabricated anatomical healing abutment (AHA) following immediate implant placement after tooth extraction. The AHA is a healing component designed to better reproduce the natural emergence profile of the extracted tooth and provide anatomical support to the surrounding peri-implant soft tissues during the healing period. After placement of the dental implant, the anatomical prefabricated healing abutment will be connected to the implant and maintained throughout the initial healing phase until the definitive implant-supported restoration is provided according to standard clinical procedures.\n\nThe intervention is intended to evaluate whether maintaining a more natural tissue contour during healing improves preservation of peri-implant soft tissue volume and stability compared with a conventional healing abutment. Participants will undergo routine clinical follow-up evaluations to measure changes in the soft tissues.",[13],"Device: scannable anatomical healing abutment",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Healing Abutment Group","ACTIVE_COMPARATOR","Participants assigned to the control group will receive a conventional healing abutment following immediate implant placement after tooth extraction. The conventional healing abutment represents the standard approach commonly used during the implant healing phase and is designed to allow the surrounding soft tissues to heal and form an appropriate contour around the implant site before placement of the definitive implant-supported restoration.\n\nFollowing implant placement, the conventional healing abutment will be connected to the implant and maintained during the initial healing period according to standard clinical protocols. Participants will undergo the same follow-up schedule and evaluations as the experimental group. Data collected during the 12-month follow-up period will be used to compare changes in peri-implant soft tissue contour, tissue volume preservation, bone remodeling, implant stability, and other clinical outcomes between the control and test groups.",[19],"Device: Standard Healing Abutment for Dental Implants",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","scannable anatomical healing abutment","The anatomical prefabricated healing abutment (AHA) is a dental implant healing component specifically designed to reproduce the natural emergence profile of the extracted tooth and provide anatomical support to the peri-implant soft tissues during the healing phase following immediate implant placement. Unlike conventional healing abutments, which typically have a standardized cylindrical shape, the AHA is designed with an anatomical contour intended to better maintain the 3D shape and volume of the soft tissues surrounding the implant. The intervention consists of placement of the AHA immediately after implant insertion and its use throughout the healing period until delivery of the definitive implant-supported restoration. The effectiveness of the AHA will be evaluated by comparing three-dimensional soft tissue volume changes, tissue contour preservation, bone remodeling, implant positioning outcomes, and clinical parameters with those observed using a conventional healing abutment.",[9],[27],"AHA",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Standard Healing Abutment for Dental Implants","The conventional healing abutment is a standard prefabricated healing component used during the healing phase following dental implant placement. Unlike the anatomical prefabricated healing abutment evaluated in the experimental group, it has a standardized, generally cylindrical contour and is not specifically designed to replicate the natural emergence profile of the extracted tooth. After implant placement, it is connected to the implant to allow the surrounding soft tissues to heal and establish an appropriate peri-implant tissue contour before placement of the definitive implant-supported restoration. The intervention consists of the placement and maintenance of the conventional healing abutment during the healing period according to standard clinical practice. Outcomes will be compared with the anatomical prefabricated healing abutment group to evaluate differences in soft tissue volume preservation, tissue contour changes, bone remodeling, and other clinical parameters.",[15],[33],"Titanium Prefabricated Healing Abutment",[35,38],{"name":36,"affiliation":5,"role":37},"Luis Mezzomo, PhD","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":40,"role":37},"Waldemar Polido, PhD","Indiana University",[42,47],{"name":36,"role":43,"phone":44,"phoneExt":45,"email":46},"CONTACT","312-996-3535",null,"lmezzomo@uic.edu",{"name":48,"role":43,"phone":49,"phoneExt":45,"email":50},"Megan Dietrich, Research Coordinator","312-996-7226","meghand4@uic.edu",[52,68],{"facility":53,"status":45,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"University of Illinois Chicago College of Dentistry","Chicago","Illinois","60612","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-87.65005,41.85003,{"lat":63,"lon":62},[66],{"name":67,"role":43,"phone":49,"phoneExt":45,"email":50},"Megan Dietrich, Clinical Research Coordinator",{"facility":69,"status":45,"city":70,"state":71,"zip":72,"country":57,"countryCode":58,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Indiana University School of Dentistry","Indianapolis","Indiana","46202",{"type":60,"coordinates":74},[75,76],-86.15804,39.76838,{"lat":76,"lon":75},[79],{"name":39,"role":43,"phone":80,"phoneExt":45,"email":81},"317-922-5835","wdpolido@iu.edu",{"type":37,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"Luis Mezzomo","Clinical Associate Professor",[86,87,89],{"name":40,"class":6},{"name":88,"class":6},"ITI International Team for Implantology, Switzerland",{"name":90,"class":91},"Institut Straumann AG","INDUSTRY","100648842","tissue-preservation-in-immediate-1c-implants-using-an-anatomical-prefabricated-healing-abutment-100648842",false,"NCT07727980","Tissue Preservation in Immediate 1C Implants Using an Anatomical Prefabricated Healing Abutment","Aharct","Inclusion Criteria:\n\n* Willing to sign an IRB-approved informed consent and HIPAA authorization form prior to participation.\n* Between the ages of 20 and 75 years old.\n* ASA Classification I and II.\n* Hopeless maxillary or mandibular posterior teeth, eligible for immediate implantation, and with intact\u002Fsuccessfully restored adjacent teeth.\n* Willing to perform tasks associated with the study and to attend all study visits.\n\nExclusion Criteria:\n\n* HbA1c \\>6.5%) as per a chairside test (Siemens Bayer DCA 2000+);\n* smoker (any status);\n* immunodeficiency;\n* history of head and neck radiotherapy;\n* intake of bone anti-resorptive drugs;\n* cysts or tumors in the area;\n* self-reported pregnancy;\n* poor oral hygiene;\n* active periodontal disease;\n* acute endodontic infection and pus discharge on the site itself and adjacent areas;\n* lack of mutually protected occlusion;\n* insufficient inter-occlusal clearance (\\\u003C15 mm);\n* sites with an existing midfacial mucogingival recession\u002Fdeficiency (scar tissue);\n* sites with a high-scalloped, thin biotype.\n\nThose who appear to qualify will have a CBCT scan taken with an open bite and proper retractions of the cheek, lips, and tongue (standard of care), and the following inclusion criteria, based on the CBCT results, must be present in order for the subject to be fully enrolled in the study:\n\n* Sites with an intact or minimally damaged facial bone plate measuring greater than 1 mm in thickness;\n* Sites with at least 5 mm of healthy bone between the socket apex and the relevant anatomical structure (e.g., the maxillary sinus floor in the maxilla or the inferior alveolar nerve, submandibular\u002Fsublingual fossa, mental foramen, or anterior loop of the inferior alveolar nerve in the mandible);\n* In multirooted molar sockets, the presence of a short root trunk and an interradicular septum with a minimum height of 5 mm and a thickness of 3 mm.","ALL","20 Years","75 Years",{"count":103,"type":104},30,"ESTIMATED","INTERVENTIONAL",[107],"NA","The goal of this clinical trial is to evaluate whether an anatomical prefabricated healing abutment (AHA) improves tissue preservation and clinical outcomes following immediate implant placement after tooth extraction in adults. Although immediate implant placement is a well-established treatment for replacing missing teeth, healing can result in changes to the surrounding bone and soft tissues that may affect the esthetic appearance, function, and long-term stability of the implant-supported restoration. This study will compare an anatomical healing abutment, designed to mimic the natural tooth emergence profile and support peri-implant tissues during healing, with a conventional healing abutment. The primary objectives are to determine whether the AHA better preserves soft tissue contours and alveolar bone, improves implant positioning accuracy and tissue stability during healing, and differs from a conventional healing abutment in complications or adverse events. Eligible participants will be adults requiring extraction of a hopeless tooth in the posterior maxilla or mandible who are suitable candidates for immediate implant placement. Following tooth extraction and implant placement, participants will receive either an anatomical prefabricated healing abutment or a conventional healing abutment and will return for scheduled follow-up visits over approximately 12 months to assess healing, implant stability, and changes in the surrounding hard and soft tissues. Researchers will collect clinical measurements, digital intraoral scans, photographs, and radiographic images throughout the study. Additional research imaging will be used to generate three-dimensional models to measure tissue volume changes and implant position accuracy. Specialized software will compare changes between the two groups over time. Safety will be evaluated by monitoring participants for complications, discomfort, inflammation, implant-related problems, and other adverse events throughout follow-up. All procedures will be performed by trained dental professionals using established clinical protocols. The results may improve understanding of how healing abutment design influences tissue preservation after immediate implant placement and help optimize future implant therapy by supporting better functional, esthetic, and long-term outcomes.",[110,111,112,113,114,115,116,117],"Tooth Loss","Dental Implant","Clinical Trials","Randomized Controlled Trial","Immediate Dental Implant Placement","Molar Extraction Socket","Maxilla","MANDIBLE",[119,120,121,122,123,124],"3-dimensional imaging","wound healing","healing abutments","immediate implant placement","soft tissue dimensional alterations","implant position accuracy","NOT_YET_RECRUITING","2026-07-24",{"date":128,"type":129},"2026-07-27","ACTUAL",{"date":131,"type":104},"2026-09",{"date":133,"type":104},"2028-09",{"name":5,"class":6},2]