[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650514":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":42,"centralContacts":54,"locations":61,"responsibleParty":76,"collaborators":33,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":33,"enrollmentInfo":88,"targetDuration":33,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":100,"overallStatus":109,"whyStopped":33,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"University of Bern","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Fixed ovate pontic provisional","EXPERIMENTAL","Following minimally traumatic, flapless tooth extraction, the alveolar socket is grafted with Bio-Oss Collagen. Socket sealing is achieved by a fixed, 3D-printed provisional restoration incorporating an ovate pontic design that extends approximately 2 mm apical to the mucosal margin, providing active soft tissue support to maintain interproximal papilla height and facial soft tissue contour during healing. The provisional is retained by adhesive bonding or temporary cementation on the adjacent teeth. No additional collagen matrix or sutures are placed.",[13,14],"Device: Bio-Oss Collagen","Procedure: Fixed 3D-printed ovate pontic provisional restoration",{"label":16,"type":17,"description":18,"interventionNames":19},"Removable Essix provisional with collagen matrix seal","ACTIVE_COMPARATOR","Following minimally traumatic, flapless tooth extraction, the alveolar socket is grafted with Bio-Oss Collagen. The socket is sealed with a porcine-derived collagen matrix (Mucograft Seal) secured with four to six single interrupted sutures, without primary closure. A removable Essix-type provisional restoration with an integrated artificial tooth is delivered; the pontic is positioned above the mucosal level without intentional soft tissue contact.",[13,20,21],"Device: Mucograft Seal","Procedure: Removable Essix provisional restoration",[23,29,34,38],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","Bio-Oss Collagen","Deproteinized bovine bone mineral with 10% collagen (Geistlich Pharma AG, Wolhusen, Switzerland). Used for alveolar ridge preservation by socket grafting after tooth extraction. CE-marked and used within the approved indication.",[9,16],[9,16],{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Mucograft Seal","Patient-specific 3D-printed provisional restoration (PMMA or comparable clinically approved dental provisional material) incorporating an ovate pontic design. Retained by adhesive bonding or temporary cementation on the adjacent teeth. The convex, highly polished pontic extends approximately 2 mm apical to the mucosal margin and above the level of the bone graft, providing active soft tissue support.",[16],null,{"type":35,"name":36,"description":31,"armGroupLabels":37,"otherNames":33},"PROCEDURE","Fixed 3D-printed ovate pontic provisional restoration",[9],{"type":35,"name":39,"description":40,"armGroupLabels":41,"otherNames":33},"Removable Essix provisional restoration","Patient-specific removable thermoplastic Essix-type appliance with an integrated artificial tooth. The pontic is positioned above the mucosal level without intentional soft tissue contact. Delivered at the surgical visit after socket sealing with the collagen matrix.",[16],[43,47,50],{"name":44,"affiliation":45,"role":46},"Nicole Schenk, Dr. med. dent.","University of Bern, Department of Reconstructive Dentistry and Gerodontology","PRINCIPAL_INVESTIGATOR",{"name":48,"affiliation":45,"role":49},"Martin Schimmel, Prof. Dr. med. dent.","STUDY_CHAIR",{"name":51,"affiliation":52,"role":53},"Emilio Couso-Queiruga, PD Dr. med. dent.","University of Bern, Department of Oral Surgery and Stomatology","STUDY_DIRECTOR",[55,59],{"name":44,"role":56,"phone":57,"phoneExt":33,"email":58},"CONTACT","+41 31 684 06 35","nicole.schenk@unibe.ch",{"name":48,"role":56,"phone":57,"phoneExt":33,"email":60},"martin.schimmel@unibe.ch",[62],{"facility":45,"status":33,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Bern","Canton of Bern","3010","Switzerland","CH",{"type":69,"coordinates":70},"Point",[71,72],7.44744,46.94809,{"lat":72,"lon":71},[75],{"name":44,"role":56,"phone":57,"phoneExt":33,"email":58},{"type":77,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100650514","ovate-pontic-versus-essix-provisional-after-tooth-extraction-and-alveolar-ridge-preservation-pontic-essix-100650514",false,"NCT07748871","Ovate Pontic Versus Essix Provisional After Tooth Extraction and Alveolar Ridge Preservation (Pontic-Essix)","Socket Sealing With a Fixed Ovate Pontic Provisional Versus a Removable Provisional Following Tooth Extraction and Alveolar Ridge Preservation: A Randomized Controlled Trial","Pontic-Essix","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* ASA physical status I or II\n* Requiring a single non-molar tooth extraction (incisor, canine, or premolar) in the maxilla or mandible, with planned tooth replacement\n* Extraction site bounded by natural, periodontally stable adjacent teeth\n* Intact alveolar socket upon extraction, or no more than one bony wall (facial, palatal, or lingual) presenting a dehiscence extending less than 50% of the total bony wall height\n* Willingness and ability to comply with the follow-up protocol\n* Ability to give informed consent, as documented by signature\n\nExclusion Criteria:\n\n* Current smokers, or former smokers who quit less than 6 months before extraction\n* Uncontrolled diabetes mellitus (HbA1c \\> 7.0%)\n* Clinical attachment loss ≥ 2 mm at the extraction site\n* Active or recent chemotherapy, or history of head and neck radiotherapy\n* Current or previous bisphosphonate therapy within the past 10 years\n* Immunosuppressive medication\n* Active oral or systemic acute infection\n* Severe hematologic disorder, hepatic or renal failure, or any clinically relevant bleeding disorder or anticoagulant medication that cannot be safely managed for the planned surgical procedure\n* Pregnancy or lactation\n* Known allergy or hypersensitivity to any of the study materials, including bovine-derived bone substitute, porcine-derived collagen matrix, or collagen-containing biomaterials\n* Any other disease or medication that may compromise normal wound healing\n* Inability to follow the study procedures (e.g., insufficient language comprehension, cognitive impairment, psychological disorder, or dementia)\n* Known or suspected non-compliance\n* Participation in another clinical trial that may interfere with the present study","ALL","18 Years",{"count":89,"type":90},40,"ESTIMATED","INTERVENTIONAL",[93],"NA","This randomized controlled trial compares two provisional socket-sealing concepts following single non-molar tooth extraction and alveolar ridge preservation: a fixed, tooth-supported, 3D-printed ovate pontic provisional restoration providing active soft tissue support (test) versus a removable Essix-type provisional restoration without intentional soft tissue contact combined with a porcine collagen matrix seal (control). Both groups receive alveolar ridge preservation using a deproteinized bovine bone mineral with 10% collagen. The primary endpoint is interproximal soft tissue height at 5 months, adjusted for baseline, assessed by digital superimposition of intraoral surface scans. Up to 40 participants will be enrolled at the University of Bern School of Dental Medicine.",[96,97,98,99],"Tooth Loss \u002F Rehabilitation","Tooth Extraction","Alveolar Bone Loss","Alveolar Ridge Augmentation",[101,102,103,104,105,106,107,108],"alveolar ridge preservation","ovate pontic","socket sealing","provisional restoration","interproximal soft tissue","papilla","digital superimposition","randomized controlled trial","NOT_YET_RECRUITING","2026-07-31",{"date":112,"type":113},"2026-08-06","ACTUAL",{"date":115,"type":90},"2026-10",{"date":117,"type":90},"2029-02",{"name":5,"class":6},1]