Peri-implant Soft Tissue HealingNCT07279090
Spatiotemporal Single-cell Atlas of Peri-implant Soft Tissue Healing
A study testing Healing Abutment Gingival Healing Post-Implantation in people with Peri-implant Soft Tissue Healing, run by Stomatological Hospital Affiliated with Fujian Medical University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Soft Tissue Healing
- What is being tested?
- Healing Abutment Gingival Healing Post-Implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
School and Hospital of Stomatology, Fujian Medical University
Fuzhou, Fujian, 350004
Hui Cheng, +86 18960883888, ch_fujian@163.com
About this study
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.
Read more
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
- Being tested
- Healing Abutment Gingival Healing Post-Implantation
- Keywords
- Peri-implant soft tissue healing, scRNA-seq
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healing Abutment Gingival Healing Post-ImplantationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Healing Abutment Gingival Healing Post-Implantation | Experimental | Not described Receives: Procedure: Healing Abutment Gingival Healing Post-Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (%)
Measured: 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
Measured: 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)
Measured: 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.
Measured: Day 4, Week 2, Week 4 and Week 8-10 post-implantation.
Secondary outcomes (4)
Histological Tissue Morphology
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.
Measured: Day 4, Week 2, Week 4 and Week 8-10 post-implantation.
Immune and Stromal Cell Quantification
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.
Measured: Day 4, Week 2, Week 4 and Week 8-10 post-implantation.
Junctional Epithelium Length
Measurement of junctional epithelium length along the implant surface using histological sections and digital image analysis software.
Unit of Measure: Length (µm)
Measured: Day 4, Week 2, Week 4, and Week 8-10 post-implantation.
Basement Membrane Protein Expression
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 (%)
Measured: Day 4, Week 2, Week 4, and Week 8-10 post-implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start20 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant Soft Tissue HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stomatological Hospital Affiliated with Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Hui, Stomatological Hospital Affiliated with Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279090
- Sponsor's protocol ID
- 20250829
- Status last verified
- Dec 2025
- First submitted
- 16 Sep 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Taking into account factors such as the needs of subsequent research, the final decision has not yet been made.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatiotemporal Single-cell Atlas of Peri-implant Soft Tissue Healing
- ClinicalTrials.gov ID
- NCT07279090
- Acronym / sponsor ID
- 20250829
- Conditions
- Peri-implant Soft Tissue Healing
- Keywords
- Peri-implant soft tissue healing, scRNA-seq
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Stomatological Hospital Affiliated with Fujian Medical UniversityUniversity, hospital or other
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healing Abutment Gingival Healing Post-Implantation | Experimental | Procedure: Healing Abutment Gingival Healing Post-Implantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healing Abutment Gingival Healing Post-ImplantationThe 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. | Procedure or surgery | Healing Abutment Gingival Healing Post-Implantation |
Primary outcome
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.
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 (%)
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
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)
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.
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: Undecided. Taking into account factors such as the needs of subsequent research, the final decision has not yet been made.
Related trials for Peri-implant Soft Tissue Healing
Not yet recruiting
Effect of Customized Versus Stock Healing Abutments on Peri-Implant Soft Tissue
Peri-Implantitis
Active, not recruiting
Healing Outcomes of Peri-implant Soft Tissues With Different Healing Abutments
Implant
Active, not recruiting
Clinical Assessment of UV Photofunctionalization on Stability and Osseointegration of Early Loaded Implants
Evaluating the Clinical Efficacy of Applying Ultraviolet Photofunctionalization (UV phF) to Standard Titanium Implants Immediately Before Surgery, Monitoring Early Implant Stability and Osseointegration During the Critical Initial Healing Phase
RecruitingObservational study
Immediate Molar Implants With Customized Healing Abutments in Different Post-Extraction Socket Classes
Tooth Loss, Alveolar Bone Loss
Recruiting
Soft Tissue Augmentation Around Dental Implants Using Connective Tissue Graft, Submerged Tenting Abutment, or Sub-crestal Implant Placement
Peri-implant Soft Tissue Deficiency, Partial Edentulism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healing Abutment Gingival Healing Post-Implantation in people with Peri-implant Soft Tissue Healing, run by Stomatological Hospital Affiliated with Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui Cheng (+86 18960883888, ch_fujian@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.