[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07713199":3,"trial-entities:NCT07713199":126,"trial-summary:NCT07713199":130},{"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":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":39,"secondary_outcomes":44,"sex":74,"minimum_age":75,"maximum_age":76,"healthy_volunteers":15,"eligibility_criteria":77,"std_ages":94,"locations":97,"central_contacts":117,"overall_officials":121,"references":124,"see_also_links":125},"NCT07713199","STUDY00002814","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™)","NOT_YET_RECRUITING","2029-01-31","2026-07","2026-07-20","2026-09-15","The University of Texas Health Science Center at San Antonio","OTHER",false,"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.","The investigators are examining the amount of gingiva gained when using 2 different types of donor tissue to do the graft surgery: either gum tissue from the patient's palate or commercially available tissue called a \"collagen matrix\" that comes from an animal source (the Achilles tendon of pigs). Palatal tissue has been used for over 70 years for this purpose, while animal sources have been used for about 15 years. So far, no studies have been done to see if there are any differences in the amount of new gum tissue we see when we use the palatal tissue approach versus the animal tissue approach. The purpose of this study is to compare the 2 approaches during a period of 6 months after graft surgery to determine if the change in gingiva is similar or different between the 2 approaches.\n\nTeeth are surrounded by soft tissue called gingiva (gums). Sometimes, the amount of gingiva is very small, which can lead to problems such as receding gums, pain on toothbrushing\u002Fflossing, and an increased risk for gum diseases. In such instances, dentists commonly perform surgery procedures to increase the amount of gum tissue around teeth or dental implants. \"Gum grafting\" involves taking a small piece of tissue from one location (called the donor site and donor tissue) and transplanting it to the area where the amount of gingiva is inadequate (called the recipient site because this location will receive the donor tissue).",[19,20],"Gingival Recession Localized Moderate","Dental Implant",[22,23,24],"Tissue graft surgery","Receding gums","Keratinized tissue","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},68,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DEVICE","Zderm","The material used at the graft recipient site is xenograft collagen soft tissue matrix derived from porcine Achilles tendon (ZdermTM)",[38],"Test Group Porcine Collagen Matrix",[40],{"measure":41,"description":42,"timeFrame":43},"Change in width of Keratinized Tissue","The change in vertical distance from the gingival margin to the keratinized base of the grafted site measured on digital scans, and from the fixed reference point on the customized measurement stent to the keratinized base of the grafted site measured intra-orally.","Baseline to 6 months",[45,48,51,54,58,62,66,70],{"measure":46,"description":47,"timeFrame":43},"Graft dimension width change","Dimensional change (\"shrinkage\") of the grafted area during healing will be assessed by measuring graft width (vertical dimension)",{"measure":49,"description":50,"timeFrame":43},"Graft Length Change","Dimensional change (\"shrinkage\") of the grafted area during healing will be assessed by measuring graft length (horizontal dimension).",{"measure":52,"description":53,"timeFrame":43},"Dimensional area change","Dimensional change of the grafted area during healing will be assessed by endpoints of graft width (vertical dimension), graft length (horizontal dimension) to measure graft area.",{"measure":55,"description":56,"timeFrame":57},"Length of surgery in minutes","The length of surgery in minutes will be assessed by use of a standard timer. The timer will start when the first incision is made. The timer will stop 3 minutes after the final suture is placed and pressure has been applied at the recipient surgery site.","Time to complete surgery (approximately 2-3 hours)",{"measure":59,"description":60,"timeFrame":61},"Numerical rating score for color match","A 21-point numerical rating scale (NRS-21) with which patients and clinicians can assess color match of the grafted area to the surrounding soft tissue. The NRS-21 scale allows scores ranging from 0 (worst color match) to 10 (best color match) in increments of 0.5.","One month to 6 months",{"measure":63,"description":64,"timeFrame":65},"San Antonio Texture index (SaTi)","A 4-point texture index score for clinicians to assess the tissue texture match of the grafted area to the surrounding soft tissue. The SATi is a four-point rating scale as follows:\n\n1. Major variation in texture compared to adjacent gingiva\n2. Moderate variation in texture compared to adjacent gingiva\n3. Minor variation in texture compared to adjacent gingiva\n4. Identical to adjacent gingiva","One month to six months",{"measure":67,"description":68,"timeFrame":69},"Pain Score on Numeric Rating Scale (NRS)","Pain associated with the surgery will be assessed by patients using NRS-21 that ranges from 0 to 10 in 0.5 increments, with 0 indicating no pain and 10 indicating intolerable pain. Patients will record NRS-21 scores on paper forms","24 to 168 hours after surgery",{"measure":71,"description":72,"timeFrame":73},"Analgesic consumption","Participants will count and document number of analgesics (ibuprofen and acetaminophen) taken after surgery","24 to 168 hours","ALL","18 Years","89 Years",{"inclusion":78,"exclusion":84,"raw_text":93},[79,80,81,82,83],"Male or female patient aged 18 to 89","One or more teeth\u002Fdental implants, excluding 3rd molars, that have been identified by dental faculty as requiring augmentation of KT","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)","Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non-pregnant women of child-bearing potential as eligible.","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).",[85,86,87,88,89,90,91,92],"Patients with a known allergy to collagen of animal origins.","Patients who will not cooperate with the follow-up schedule.","Patients will not be entered who are mentally incompetent, prisoners, or pregnant.","Patients who require soft tissue grafting specifically to treat exposed root coverage (gingival recession)","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).","Patients who become pregnant during the study will be withdrawn and standard care will be delivered.","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.","Smokers who smoke \\>10 cigarettes per day (more than 10 cigarettes per day)","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)",[95,96],"ADULT","OLDER_ADULT",[98],{"facility":99,"city":100,"state":101,"zip":102,"country":103,"contacts":104,"geoPoint":114},"University of Texas Health Science Center at San Antonio School of Dentistry","San Antonio","Texas","78229","United States",[105,110],{"name":106,"role":107,"phone":108,"email":109},"Brian L Mealey, DDS, MS","CONTACT","210-567-3318","mealey@uthscsa.edu",{"name":111,"role":107,"phone":112,"email":113},"Angela Palaiologou-Gallis, DDS","210-567-3589","palaiologouA@uthscsa.edu",{"lat":115,"lon":116},29.42412,-98.49363,[118,119],{"name":106,"role":107,"phone":112,"email":109},{"name":111,"role":107,"phone":120,"email":113},"210-567-3567",[122],{"name":106,"affiliation":13,"role":123},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":127,"biomarkers":129},[20,128],"Gingival Recession",[],{"nct_id":4,"found":131,"summary":132,"prompt_version":142},true,{"design":133,"status":134,"heading":135,"summary":136,"follow_up":137,"word_count":138,"commitments":139,"compensation":140,"drugs_mentioned":141},"This study plans to enroll 68 participants to compare two different graft materials. It is an interventional study, meaning participants will receive one of the two treatments.","completed","Comparing Gum Tissue Grafts: Palate Tissue vs. Zderm™","This study is for people with little gum tissue around their teeth or dental implants who need a gum graft. We are comparing two ways to do this surgery: using gum tissue from your own palate, or using a material called Zderm™ (a collagen matrix from pig Achilles tendon). Both methods have been used for many years, but we don't know if one works better than the other. This study will help us understand if there's a difference in how much new gum tissue grows with each approach over 6 months. You can join if you are between 18 and 89 years old and your dentist has recommended a gum tissue graft.","Participants will be followed for 6 months after the graft surgery to measure the width of keratinized tissue.",112,"Participants will have gum graft surgery and will be followed for 6 months after the surgery to measure changes in gum tissue.","Not stated in the trial record.",[35],"v2"]