[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640454":3},{"organization":4,"outcomesModule":7,"designInfo":68,"detailedDescription":67,"studyPopulation":70,"armGroups":71,"interventions":82,"overallOfficials":91,"centralContacts":96,"locations":102,"responsibleParty":112,"collaborators":67,"id":116,"slug":67,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":67,"eligibilityCriteria":121,"healthyVolunteers":122,"sex":123,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":67,"studyType":129,"phases":67,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":135,"whyStopped":67,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Biruni University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":28,"otherOutcomes":67},[9,13,15,18,20,24],{"measure":10,"description":11,"timeFrame":12},"The three-dimensional changes of free gingival graft","An intraoral digital scanner will be used to assess the graft's dimensions alterations.","Baseline",{"measure":10,"description":11,"timeFrame":14},"Postoperative baseline (immediately after surgery)",{"measure":16,"description":11,"timeFrame":17},"The three-dimensional changes of free gingival graft.","1st month",{"measure":16,"description":11,"timeFrame":19},"3rd month",{"measure":21,"description":22,"timeFrame":23},"Histological alterations in free gingival grafts","Histomorphometric and immunohistochemical evaluation of epithelial thickness and Type I and Type III collagen ratios in free gingival graft samples obtained from the palatal donor site.","Baseline (initial graft harvesting procedure)",{"measure":25,"description":26,"timeFrame":27},"Histological alterations in re-harvested free gingival grafts","Histomorphometric and immunohistochemical evaluation of epithelial thickness and Type I and Type III collagen ratios in free gingival graft samples reharvested from the same palatal donor site.","63 days after the initial surgery (re-harvesting procedure)",[29,33,34,35,38,39,40,43,44,48,50,52,56,57,60,63],{"measure":30,"description":31,"timeFrame":32},"Keratinized mucosa width","The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ) Measurements will be made at three points on tooth (mesiobuccal, midbuccal, distobuccal) using a periodontal probe.","Baseline (prior to therapy)",{"measure":30,"description":31,"timeFrame":17},{"measure":30,"description":31,"timeFrame":19},{"measure":36,"description":37,"timeFrame":32},"Gingival Recession Width","The widest horizontal distance between the mesial and distal gingival margins of the recession defect at the level of the cementoenamel junction (CEJ) will be measured using a periodontal probe held horizontally.",{"measure":36,"description":37,"timeFrame":17},{"measure":36,"description":37,"timeFrame":19},{"measure":41,"description":42,"timeFrame":12},"Gingival Thickness","Following local anesthesia, measurements will be performed at the distobuccal, midbuccal, and mesiobuccal aspects of the teeth in the recipient area by inserting a #20 spreader with a silicone stopper perpendicular to the gingival surface, 2 mm apical to the gingival margin. After hard tissue contact is achieved, the distance between the tip of the spreader and the silicone stopper will be measured using a digital caliper. The mean value of the measurements will be recorded.",{"measure":41,"description":42,"timeFrame":19},{"measure":45,"description":46,"timeFrame":47},"Landry Healing Index","Healing at the recipient site will be evaluated according to tissue color, presence of bleeding and granulation tissue, suppuration, and epithelialization. Healing will be scored on a scale ranging from 1 to 5.","7th day",{"measure":45,"description":46,"timeFrame":49},"14th day",{"measure":45,"description":46,"timeFrame":51},"28th day",{"measure":53,"description":54,"timeFrame":55},"Growth factor levels in wound fluid","Wound fluid samples will be collected from the mesiocoronal, distocoronal, mesioapical, and distoapical margins of the surgical recipient site using paper strips (Periopaper®, Oraflow, Plainview, NY, USA). The strips will be gently placed at the relevant sites for 30 seconds while avoiding mechanical trauma. VEGF-A, PDGF, and TGF-β1 levels will be evaluated.","3rd day",{"measure":53,"description":54,"timeFrame":47},{"measure":58,"description":59,"timeFrame":23},"Protein expression levels in free gingival grafts,","Biochemical evaluation of type I collagen, type III collagen, and α-SMA protein expression levels in free gingival graft samples obtained from the donor site.",{"measure":61,"description":62,"timeFrame":27},"Protein expression levels in free gingival grafts","Biochemical evaluation of type I collagen, type III collagen, and α-SMA protein expression levels in free gingival graft samples obtained from the same donor site.",{"measure":64,"description":65,"timeFrame":66},"Patient reported outcomes","After the surgical procedure, patients will be asked to complete a form consisting of 3 items: (1) assessment of the intensity of postoperative pain\u002Fdiscomfort (by Visual Analog Scale), (2) duration of pain (in days) and (3) number of analgesic tablets taken.","10th day",null,{"allocation":67,"interventionModel":67,"interventionModelDescription":67,"primaryPurpose":67,"observationalModel":6,"timePerspective":69,"maskingInfo":67},"PROSPECTIVE","Systemically healthy, non-smoking individuals aged 18-65 years with insufficient keratinized gingiva (\\\u003C2 mm; Lang \\& Löe, 1972) involving the bilateral mandibular canine and\u002For premolar regions will be included in the study.",[72,77],{"label":73,"type":67,"description":74,"interventionNames":75},"First free gingival graft","Recipient sites treated with free gingival grafts harvested from the palatal donor site during the initial surgical procedure.",[76],"Procedure: Free gingival graft",{"label":78,"type":67,"description":79,"interventionNames":80},"Re-harvested free gingival graft","Recipient sites treated with free gingival grafts re-harvested from the same palatal donor site 63 days after the initial surgery.",[81],"Procedure: Re-harvested free gingival graft",[83,88],{"type":84,"name":85,"description":86,"armGroupLabels":87,"otherNames":67},"PROCEDURE","Free gingival graft","Following adequate local anesthesia, a horizontal incision will be made at the level of the mucogingival junction to prepare the recipient bed. A split-thickness flap will be elevated without disturbing the periosteum. A free gingival graft will be harvested from the palatal donor site during the initial surgical procedure. The harvested graft will then be transferred to the recipient site, shaped to the desired dimensions, and stabilized with sutures.",[73],{"type":84,"name":78,"description":89,"armGroupLabels":90,"otherNames":67},"Following adequate local anesthesia, a horizontal incision will be made at the level of the mucogingival junction to prepare the recipient bed. A split-thickness flap will be elevated without disturbing the periosteum. A free gingival graft will be reharvested from the same palatal donor site 63 days after the initial surgery. The harvested graft will then be transferred to the recipient site, shaped to the desired dimensions, and stabilized with sutures.",[78],[92],{"name":93,"affiliation":94,"role":95},"Ayşe Ege Selman","Biruni University, Faculty of Dentistry, Department of Periodontology","STUDY_CHAIR",[97],{"name":98,"role":99,"phone":100,"phoneExt":67,"email":101},"Ebru Dilmen","CONTACT","+905435673736","231115001@st.biruni.edu.tr",[103],{"facility":5,"status":67,"city":104,"state":67,"zip":67,"country":105,"countryCode":67,"cosmosGeoPoint":106,"geoPoint":111,"contacts":67},"Istanbul","Turkey (Türkiye)",{"type":107,"coordinates":108},"Point",[109,110],28.94966,41.01384,{"lat":110,"lon":109},{"type":113,"investigatorFullName":114,"investigatorTitle":115,"investigatorAffiliation":5,"oldNameTitle":67,"oldOrganization":67},"PRINCIPAL_INVESTIGATOR","Ayse Ege SELMAN","Asst. Prof.","100640454",false,"NCT07617987","Reharvested Free Gingival Grafts: 3D Shrinkage and Histological Changes","Three-Dimensional Assessment of Graft Shrinkage in Relation to Histological Alterations in Reharvested Free Gingival Grafts From the Same Palatal Donor Site","Inclusion Criteria:\n\n* Individuals aged between 18 and 65 years,\n* Absence of any systemic disease that may adversely affect periodontal health and wound healing,\n* Non-smokers,\n* Periodontally healthy individuals,\n* Mean plaque index (PI) score \\\u003C1 following non-surgical periodontal therapy (NSPT),\n* No use of antibiotics or anti-inflammatory drugs within the last 3 months,\n* Not being pregnant or breastfeeding,\n* Willingness to participate in the study by signing the informed consent form.\n\nExclusion Criteria:\n\n* Presence of any systemic disease contraindicating surgical procedures,\n* Use of medications or supplements affecting bleeding or wound healing,\n* Presence of uncontrolled diabetes mellitus (HbA1c \\>7),\n* Pregnancy or breastfeeding,\n* History of chemotherapy or radiotherapy within the last 6 months,\n* History of antibiotic use within the last 3 months,\n* Palatal mucosal thickness \\\u003C3 mm or presence of palatal torus,\n* Presence of deep and narrow (U-shaped) or shallow palatal vaults interfering with palatal measurements,\n* Non-compliance with treatment or follow-up protocols.",true,"ALL","18 Years","65 Years",{"count":127,"type":128},20,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to evaluate the dimensional stability of free gingival grafts (FGG) and to investigate the relationship between graft shrinkage (GS) and the histological and biochemical characteristics of grafts reharvested from the same palatal donor site. The primary objective is to investigate the relationship between histological alterations in grafts reharvested from the same donor site and graft shrinkage at the recipient site.\n\nThis study is designed as a split-mouth study in which FGGs are applied to contralateral recipient sites within the same patient. Each participant will receive two grafts: an initial graft harvested from the palatal donor site and a second graft reharvested from the same donor site 63 days after the initial procedure.\n\nGraft dimensional changes will be evaluated using three-dimensional digital measurements. Intraoral digital scans will be obtained at baseline, immediately after surgery, and at 1 and 3 months postoperatively. GS will be assessed through superimposition of digital models.\n\nIn addition, histological, histomorphometric, and immunohistochemical analyses will be performed on tissue samples obtained from the donor site to evaluate collagen characteristics and epithelial structure. Furthermore, protein expression levels of specific markers, including collagen type I, collagen type III, and alpha-smooth muscle actin (α-SMA), will be assessed. Early wound healing at the recipient site will be evaluated using the Landry healing index at postoperative days 7, 14, and 28. In addition, biological mediators, including transforming growth factor beta 1 (TGF-β1), vascular endothelial growth factor A (VEGF-A), and platelet-derived growth factor (PDGF), will be analyzed in wound exudate samples obtained from the recipient site to biochemically assess the early healing process.",[132],"Insufficient Keratinized Gingiva",[134],"free gingival graft","NOT_YET_RECRUITING","2026-05-25",{"date":138,"type":139},"2026-06-01","ACTUAL",{"date":141,"type":128},"2026-06-15",{"date":143,"type":128},"2027-09-15",{"name":5,"class":6},1]