Spatiotemporal Single-cell Atlas of Peri-implant Soft Tissue Healing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Primary Outcome 1: Differentially Expressed Genes (DEGs) in Peri-implant Soft Tissues
研究概览
简要总结
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).
The 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.
Tissue 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.
Spatial 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.
This combined approach will allow for a comprehensive characterization of cellular interactions, spatial gene expression patterns, and regulatory networks specific to healing abutments.
The goal is to identify key regulatory factors that could improve peri-implant soft tissue healing and help prevent peri-implantitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-65 years
- •Healthy individuals without chronic medical conditions or severe systemic diseases
- •Able to comply with study requirements (e.g., follow-up visits)
- •No history of periodontal disease or active infection
- •Already completed four or more implant placements in the posterior tooth region
- •Adequate gingival thickness to allow for sampling and proper healing
排除标准
- •Individuals with systemic conditions that affect wound healing (e.g., diabetes, immunosuppressive therapy)
- •Smoking or alcohol abuse
- •Pregnant or breastfeeding women
- •History of severe allergic reactions to implant materials
- •Participation in another clinical study at the same time
结局指标
主要结局
Primary Outcome 1: Differentially Expressed Genes (DEGs) in Peri-implant Soft Tissues
时间窗: Day 4, Week 2, Week 4 and Week 8-10 post-implantation.
Number of genes significantly differentially expressed between experimental groups, determined by single-cell RNA sequencing (scRNA-seq) analysis (FDR \< 0.05). Unit of Measure: Number of genes.
Cell Type Composition in Peri-implant Soft Tissues
时间窗: Day 4, Week 2, Week 4, and Week 8-10 post-implantation.
Proportion (%) of each annotated cell type identified by scRNA-seq based on canonical marker expression. Unit of Measure: Percentage of total cells (%)
Enriched Biological Pathways
时间窗: Day 4, Week 2, Week 4, and Week 8-10 post-implantation
Number of significantly enriched Gene Ontology (GO) terms and KEGG pathways identified from DEGs (FDR \< 0.05). Unit of Measure: Number of enriched terms/pathways
Ligand-Receptor Interaction Strength
时间窗: Day 4, Week 2, Week 4, and Week 8-10 post-implantation
Mean interaction score of ligand-receptor pairs identified among annotated cell types using CellPhoneDB (or equivalent computational tool). Unit of Measure: Interaction score (arbitrary units)
Spatial Gene Expression Patterns
时间窗: Day 4, Week 2, Week 4 and Week 8-10 post-implantation.
Localization and expression intensity of selected DEGs across tissue regions determined by the 10x Genomics Visium platform.
次要结局
- Histological Tissue Morphology(Day 4, Week 2, Week 4 and Week 8-10 post-implantation.)
- Immune and Stromal Cell Quantification(Day 4, Week 2, Week 4 and Week 8-10 post-implantation.)
- Junctional Epithelium Length(Day 4, Week 2, Week 4, and Week 8-10 post-implantation.)
- Basement Membrane Protein Expression(Day 4, Week 2, Week 4, and Week 8-10 post-implantation.)
研究者
Cheng Hui
Professor of Prosthodontics
Stomatological Hospital Affiliated with Fujian Medical University