[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647871":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":56,"collaborators":18,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":18,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":18,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":83,"whyStopped":18,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"The University of Texas Health Science Center at San Antonio","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Test Group Porcine Collagen Matrix","ACTIVE_COMPARATOR","The recipient site to which the Zderm™ material will be placed will be prepared with a standard of care split thickness tissue flap at the site which needs augmentation of the KT.",[13],"Device: Zderm",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group - Palatal Graft","NO_INTERVENTION","The recipient site to which the palatal autogenous donor tissue will be placed will be prepared with a standard of care split thickness tissue flap at the site which needs augmentation of the KT. The harvested tissue will be trimmed to the required size and shape with surgical scissors as indicated by the number of tooth\u002Fimplant sites to be augmented",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Zderm","The material used at the graft recipient site is xenograft collagen soft tissue matrix derived from porcine Achilles tendon (ZdermTM)",[9],[26],{"name":27,"affiliation":5,"role":28},"Brian L Mealey, DDS, MS","PRINCIPAL_INVESTIGATOR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","210-567-3589","mealey@uthscsa.edu",{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},"Angela Palaiologou-Gallis, DDS","210-567-3567","palaiologouA@uthscsa.edu",[39],{"facility":40,"status":18,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"University of Texas Health Science Center at San Antonio School of Dentistry","San Antonio","Texas","78229","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-98.49363,29.42412,{"lat":50,"lon":49},[53,55],{"name":27,"role":31,"phone":54,"phoneExt":18,"email":33},"210-567-3318",{"name":35,"role":31,"phone":32,"phoneExt":18,"email":37},{"type":28,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Brian L Mealey","Clinical Professor","100647871","free-soft-tissue-grafts-fstg-using-autograft-palatal-donor-tissue-vs-xenograft-collagen-matrix-zderm-100647871",false,"NCT07713199","Free Soft Tissue Grafts FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)","Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Soft Tissue Matrix From Porcine Achilles Tendon (Zderm™)","Inclusion Criteria:\n\n* Male or female patient aged 18 to 89\n* One or more teeth\u002Fdental implants, excluding 3rd molars, that have been identified by dental faculty as requiring augmentation of KT\n* A FSTG is indicated and treatment planned to augment the KT. Coverage of exposed root surfaces is not indicated or intended. Patients needing root coverage surgical procedures re not eligible for enrollment (similar to our past studies, see references 11,12)\n* Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non-pregnant women of child-bearing potential as eligible.\n* Patients who are nonsmokers or former smokers are eligible. Current smokers may also be included if they smoke \\\u003C10 cigarettes per day (less than or equal to 10 cigarettes per day).\n\nExclusion Criteria:\n\n* Patients with a known allergy to collagen of animal origins.\n* Patients who will not cooperate with the follow-up schedule.\n* Patients will not be entered who are mentally incompetent, prisoners, or pregnant.\n* Patients who require soft tissue grafting specifically to treat exposed root coverage (gingival recession)\n* Pregnant women or women intending to become pregnant during the study period (as confirmed verbally; an over-the-counter pregnancy test will be provided if pregnancy status is unknown or suspected).\n* Patients who become pregnant during the study will be withdrawn and standard care will be delivered.\n* Patients with active or systemic infections other than periodontitis; a disease entity, condition or therapeutic regimen which decreases probability of soft tissue healing, e.g., poorly controlled diabetes, autoimmune diseases, long-term steroid therapy.\n* Smokers who smoke \\>10 cigarettes per day (more than 10 cigarettes per day)","ALL","18 Years","89 Years",{"count":70,"type":71},68,"ESTIMATED","INTERVENTIONAL",[74],"NA","Participant in this study are asked to participate because they have teeth or dental implants that were identified as having very little gum tissue and would benefit from gum tissue graft surgery. This study has 2 treatment groups that differ only in the material that will be used at the graft site:\n\n* Gum tissue taken from the patient's own palate\n* Commercially available collagen matrix derived from porcine (pig) Achilles tendon (FDA-approved for the surgery done in this study).\n\nBoth materials have been in use in dental practices for many years, but no studies have directly compared the outcomes between palatal tissue and the porcine collagen matrix we will use in this study.\n\nParticipants will be randomized into one of the 2 groups using sealed envelopes (the process is like flipping a coin). All the study visits will take place during regular dental appointments that would be scheduled even if not participating in this research.",[77,78],"Gingival Recession Localized Moderate","Dental Implant",[80,81,82],"Tissue graft surgery","Receding gums","Keratinized tissue","NOT_YET_RECRUITING","2026-07-14",{"date":86,"type":87},"2026-07-20","ACTUAL",{"date":89,"type":71},"2026-09-15",{"date":91,"type":71},"2029-01-31",{"name":5,"class":6},1]