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NCT Number: NCT07279090

Spatiotemporal Single-cell Atlas of Peri-implant Soft Tissue Healing

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.

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Key information

Conditions

Peri-implant Soft Tissue Healing

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Healing Abutment Gingival Healing Post-Implantation

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.

Primary outcomes

  1. Primary Outcome 1: Differentially Expressed Genes (DEGs) in Peri-implant Soft Tissues

    Time frame: 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.

  2. Cell Type Composition in Peri-implant Soft Tissues

    Time frame: 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 (%)

  3. Enriched Biological Pathways

    Time frame: 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

  4. Ligand-Receptor Interaction Strength

    Time frame: 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)

  5. Spatial Gene Expression Patterns

    Time frame: 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.

Secondary outcomes

  1. Histological Tissue Morphology

    Time frame: Day 4, Week 2, Week 4 and Week 8-10 post-implantation.

    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.

  2. Immune and Stromal Cell Quantification

    Time frame: Day 4, Week 2, Week 4 and Week 8-10 post-implantation.

    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.

  3. Junctional Epithelium Length

    Time frame: Day 4, Week 2, Week 4, and Week 8-10 post-implantation.

    Measurement of junctional epithelium length along the implant surface using histological sections and digital image analysis software.

    Unit of Measure: Length (µm)

  4. Basement Membrane Protein Expression

    Time frame: Day 4, Week 2, Week 4, and Week 8-10 post-implantation.

    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.

    Unit of Measure: Percentage of positive area (%)

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Cheng

CONTACT

[email protected]

+86 18960883888

Sponsors and collaborators

Lead sponsor

Stomatological Hospital Affiliated with Fujian Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 12, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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