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

NCT07279090 | Not Yet Recruiting

• 1 other identifier: 20250829
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peri-implant Soft Tissue Healing

Keywords

Peri-implant soft tissue healing; scRNA-seq

Outcome Measures

Primary Outcomes (5)

• 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 \< 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

  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

  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

  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

  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 Outcomes (4)

• 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.

Study Arms (1)

Healing Abutment Gingival Healing Post-Implantation

EXPERIMENTAL

Procedure: Healing Abutment Gingival Healing Post-Implantation

Interventions

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.

Healing Abutment Gingival Healing Post-Implantation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stomatological Hospital Affiliated with Fujian Medical University: lead

Study Sites (1)

School and Hospital of Stomatology, Fujian Medical University

Fuzhou, Fujian, 350004, China

Location

Central Study Contacts

Hui Cheng

CONTACT

+86 18960883888; ch_fujian@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Prosthodontics

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: December 12, 2025
• Study Start: December 20, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

CN (1)