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

December 13, 2025 updated by: Cheng Hui, Stomatological Hospital Affiliated with Fujian Medical University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350004
        • School and Hospital of Stomatology, Fujian Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healing Abutment Gingival Healing Post-Implantation
Procedure: Healing Abutment Gingival Healing Post-Implantation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 4, Week 2, Week 4 and Week 8-10 post-implantation.
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 (%)
Day 4, Week 2, Week 4, and Week 8-10 post-implantation.
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
Day 4, Week 2, Week 4, and Week 8-10 post-implantation
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)
Day 4, Week 2, Week 4, and Week 8-10 post-implantation
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.
Day 4, Week 2, Week 4 and Week 8-10 post-implantation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 4, Week 2, Week 4 and Week 8-10 post-implantation.
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.
Day 4, Week 2, Week 4 and Week 8-10 post-implantation.
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)
Day 4, Week 2, Week 4, and Week 8-10 post-implantation.
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 (%)
Day 4, Week 2, Week 4, and Week 8-10 post-implantation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stomatological Hospital Affiliated with Fujian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 20, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 16, 2025

First Submitted That Met QC Criteria

November 30, 2025

First Posted (Estimated)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 13, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20250829

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Taking into account factors such as the needs of subsequent research, the final decision has not yet been made.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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