Spatiotemporal Single-cell Atlas of Peri-implant Soft Tissue Healing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Healing Abutment Gingival Healing Post-Implantation.
- Who it may be relevant to
- Registry conditions: Peri-implant Soft Tissue Healing. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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 wil
Primary outcome measures
- 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.]
- Cell Type Composition in Peri-implant Soft Tissues [Time frame: 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]
- Ligand-Receptor Interaction Strength [Time frame: 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.]
Secondary outcome measures (4)
- Histological Tissue Morphology [Time frame: 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.]
- Junctional Epithelium Length [Time frame: 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
China · 1 center
- School and Hospital of Stomatology, Fujian Medical University — Fuzhou
Identifiers
NCT: NCT07279090 · 20250829