[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614399":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":40,"studyPopulation":40,"armGroups":47,"interventions":53,"overallOfficials":40,"centralContacts":58,"locations":64,"responsibleParty":80,"collaborators":40,"id":84,"slug":40,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":40,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":40,"studyType":96,"phases":97,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":104,"whyStopped":40,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Stomatological Hospital Affiliated with Fujian Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":27,"otherOutcomes":40},[9,13,17,21,24],{"measure":10,"description":11,"timeFrame":12},"Primary Outcome 1: Differentially Expressed Genes (DEGs) in Peri-implant Soft Tissues","Number of genes significantly differentially expressed between experimental groups, determined by single-cell RNA sequencing (scRNA-seq) analysis (FDR \\\u003C 0.05).\n\nUnit of Measure: Number of genes.","Day 4, Week 2, Week 4 and Week 8-10 post-implantation.",{"measure":14,"description":15,"timeFrame":16},"Cell Type Composition in Peri-implant Soft Tissues","Proportion (%) of each annotated cell type identified by scRNA-seq based on canonical marker expression.\n\nUnit of Measure: Percentage of total cells (%)","Day 4, Week 2, Week 4, and Week 8-10 post-implantation.",{"measure":18,"description":19,"timeFrame":20},"Enriched Biological Pathways","Number of significantly enriched Gene Ontology (GO) terms and KEGG pathways identified from DEGs (FDR \\\u003C 0.05).\n\nUnit of Measure: Number of enriched terms\u002Fpathways","Day 4, Week 2, Week 4, and Week 8-10 post-implantation",{"measure":22,"description":23,"timeFrame":20},"Ligand-Receptor Interaction Strength","Mean interaction score of ligand-receptor pairs identified among annotated cell types using CellPhoneDB (or equivalent computational tool).\n\nUnit of Measure: Interaction score (arbitrary units)",{"measure":25,"description":26,"timeFrame":12},"Spatial Gene Expression Patterns","Localization and expression intensity of selected DEGs across tissue regions determined by the 10x Genomics Visium platform.",[28,31,34,37],{"measure":29,"description":30,"timeFrame":12},"Histological Tissue Morphology","Assessment of epithelial continuity, connective tissue organization, and inflammatory cell infiltration in peri-implant soft tissues by hematoxylin and eosin (H\\&E) staining. Each parameter will be semi-quantitatively scored on a standardized histological scale (0-3), where 0 = none, 1 = mild, 2 = moderate, and 3 = severe.",{"measure":32,"description":33,"timeFrame":12},"Immune and Stromal Cell Quantification","Quantification of immune cells (e.g., CD68⁺ macrophages, CD3⁺ T lymphocytes) and stromal cells (e.g., fibroblast-related markers) by immunohistochemistry (IHC). Mean positive cell count per high-power field (HPF) will be calculated from representative sections.",{"measure":35,"description":36,"timeFrame":16},"Junctional Epithelium Length","Measurement of junctional epithelium length along the implant surface using histological sections and digital image analysis software.\n\nUnit of Measure: Length (µm)",{"measure":38,"description":39,"timeFrame":16},"Basement Membrane Protein Expression","Immunohistochemical detection of Laminin-332 and related basement membrane proteins indicating epithelial attachment integrity. The percentage of positive staining area will be quantified using image analysis software.\n\nUnit of Measure: Percentage of positive area (%)",null,{"allocation":42,"interventionModel":43,"interventionModelDescription":40,"primaryPurpose":44,"observationalModel":40,"timePerspective":40,"maskingInfo":45},"NA","SINGLE_GROUP","BASIC_SCIENCE",{"masking":46,"maskingDescription":40,"whoMasked":40},"NONE",[48],{"label":49,"type":50,"description":40,"interventionNames":51},"Healing Abutment Gingival Healing Post-Implantation","EXPERIMENTAL",[52],"Procedure: Healing Abutment Gingival Healing Post-Implantation",[54],{"type":55,"name":49,"description":56,"armGroupLabels":57,"otherNames":40},"PROCEDURE","The healing process of peri-implant soft tissues will be studied using a micro healing abutment (2 mm), which will be placed at least three months after implant Stage I surgery. Gingival tissue samples will then be collected at Day 4, Week 2, Week 4, and Week 8-10. At each time point, a circular incision around the micro abutment will be made using a circular punch, and the gingival tissue together with the abutment will be retrieved under local anesthesia. After sampling, the micro abutment will be replaced with a formal healing abutment to maintain healing. Samples will undergo single-cell RNA sequencing (scRNA-seq) to characterize cell types, gene expression changes, and regulatory pathways involved in soft tissue repair. Additional tissues will be used for spatial transcriptomics (ST) and histological staining.",[49],[59],{"name":60,"role":61,"phone":62,"phoneExt":40,"email":63},"Hui Cheng","CONTACT","+86 18960883888","ch_fujian@163.com",[65],{"facility":66,"status":40,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"School and Hospital of Stomatology, Fujian Medical University","Fuzhou","Fujian","350004","China","CN",{"type":73,"coordinates":74},"Point",[75,76],119.30611,26.06139,{"lat":76,"lon":75},[79],{"name":60,"role":61,"phone":62,"phoneExt":40,"email":63},{"type":81,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"PRINCIPAL_INVESTIGATOR","Cheng Hui","Professor of Prosthodontics","100614399",false,"NCT07279090","Spatiotemporal Single-cell Atlas of Peri-implant Soft Tissue Healing","Inclusion Criteria:\n\n* Age: 18-65 years\n* Healthy individuals without chronic medical conditions or severe systemic diseases\n* Able to comply with study requirements (e.g., follow-up visits)\n* No history of periodontal disease or active infection\n* Already completed four or more implant placements in the posterior tooth region\n* Adequate gingival thickness to allow for sampling and proper healing\n\nExclusion Criteria:\n\n* Individuals with systemic conditions that affect wound healing (e.g., diabetes, immunosuppressive therapy)\n* Smoking or alcohol abuse\n* Pregnant or breastfeeding women\n* History of severe allergic reactions to implant materials\n* Participation in another clinical study at the same time",true,"ALL","18 Years","65 Years",{"count":94,"type":95},5,"ESTIMATED","INTERVENTIONAL",[42],"This study aims to explore the dynamic changes in different cell types and their molecular regulatory mechanisms during the healing process of peri-implant soft tissues, using single-cell RNA sequencing (scRNA-seq) and spatial transcriptomics (ST).\n\nThe research will focus specifically on the healing of soft tissues around dental implants in human subjects with the use of a healing abutment. Participants in the healing abutment group will have a micro healing abutment placed immediately after implant placement.\n\nTissue samples will be collected at various time points (Day 4, Day 14, and Day 70) to construct a detailed single-cell map of the healing process.\n\nSpatial transcriptomics will be integrated to preserve tissue architecture, enabling the identification of the spatial distribution of different cell types and their interactions within the peri-implant microenvironment.\n\nThis combined approach will allow for a comprehensive characterization of cellular interactions, spatial gene expression patterns, and regulatory networks specific to healing abutments.\n\nThe goal is to identify key regulatory factors that could improve peri-implant soft tissue healing and help prevent peri-implantitis.",[100],"Peri-implant Soft Tissue Healing",[102,103],"Peri-implant soft tissue healing","scRNA-seq","NOT_YET_RECRUITING","2025-12-13",{"date":107,"type":108},"2025-12-16","ACTUAL",{"date":110,"type":95},"2025-12-20",{"date":112,"type":95},"2026-12-31",{"name":5,"class":6},1]