[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541881":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":34,"responsibleParty":53,"collaborators":12,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":12,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":12,"enrollmentInfo":64,"targetDuration":12,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":12,"overallStatus":36,"whyStopped":12,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"University of Bern","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: Connective Tissue Graft (CTG)","NO_INTERVENTION","Volumetric changes between groups will be compared by matching intraoral scans before and after surgery (including follow-ups after 5 years) using the engineering software Geo-Magic®.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Group B: Volume Collagen Matrix Xenograft (VCMX) Geistlich Fibro-Gide®","EXPERIMENTAL","The CTG (Group A) is the gold-standard for soft tissue augmentation, therefore it is considered the control group in this investigation.",[18],"Device: Geistlich Fibro-Gide®",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DEVICE","Geistlich Fibro-Gide®","Geistlich Fibro-Gide® is intended to be used as an implantable device for regeneration and augmentation of soft tissue in oral and maxillofacial surgery.",[14],[26],{"name":27,"affiliation":5,"role":28},"Manrique Fonseca, DDS","PRINCIPAL_INVESTIGATOR",[30],{"name":27,"role":31,"phone":32,"phoneExt":12,"email":33},"CONTACT","+41316840630","manrique.fonseca@unibe.ch",[35],{"facility":5,"status":36,"city":37,"state":12,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Bern","3010","Switzerland","CH",{"type":42,"coordinates":43},"Point",[44,45],7.44744,46.94809,{"lat":45,"lon":44},[48,51],{"name":49,"role":31,"phone":32,"phoneExt":12,"email":50},"Martin Schimmel, Prof.","martin.schimmel@unibe.ch",{"name":52,"role":28,"phone":12,"phoneExt":12,"email":12},"Manrique Fonseca, Dr. med. dent.",{"type":54,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100541881","volumetric-dimensional-changes-after-surgical-pontic-site-development-procedures-with-connective-tissue-graft-or-collagen-matrix-100541881",false,"NCT06335628","Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix","Inclusion Criteria:\n\n* Informed Consent signed by the subject\n* Age ≥ 18 years\n* Willingness to sign informed consent and to participate in the study\n* Single tooth gap or extended edentulous space in the lower or posterior jaw including a pontic site with a soft tissue deficiency.\n* Tooth gap of ≥ 8 mm.\n* Presence of natural or artificial opposing dentition\n* Sufficient vertical interocclusal space of an implant restoration (7mm)\n* Bounded by natural and periodontally stable teeth\n* Treatment plan must include tooth replacement with an implant or tooth-supported fixed dental prosthesis.\n\nExclusion Criteria:\n\n* Any physical or mental disorder that would interfere with the ability to perform adequate oral hygiene or the capability of providing written informed consent and compliance with the protocol\n* Severe bruxism, clenching habits, or presence of oro-facial pain\n* Uncontrolled diabetes mellitus (HbA1c \\>7.0)\n* Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)\n* Any active oral or systemic acute infections\n* Currently receiving chemo- or radiotherapy or a history of radiotherapy in the head and neck area\n* Severe hematologic disorders\n* Any other diseases or medications that may compromise normal wound healing\n* Pregnancy or nursing mother\n* Contraindications and limitations of the MD as described in the instructions for use: during pregnancy or lactation, children, presence of acute infection in the surgical area, patients with known sensitivity to porcine material or collagen allergies.\n* Vulnerable subjects\n* Known or suspected non-compliance\n* Drug or alcohol abuse\n* Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc.\n* Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation,\n* Enrolment of the PI, his\u002Fher family members, employees and other dependent persons",true,"ALL","18 Years",{"count":65,"type":66},38,"ESTIMATED","INTERVENTIONAL",[69],"NA","The aim of this research project is to compare two surgical procedures to improve soft tissue volume. Both procedures have already been validated, but despite their great clinical relevance, little data exists in the literature. With this study, the investigators aim to evaluate volumetric changes of connective tissue graft versus biomaterial (membrane). In addition, further clinical measurements will be taken and patient satisfaction will be assessed.",[72,73],"Connective Tissue Graft","Volume Collagen Matrix Xenograft","2026-05-26",{"date":76,"type":77},"2026-05-27","ACTUAL",{"date":79,"type":77},"2024-08-28",{"date":81,"type":66},"2030-04",{"name":5,"class":6},1]