Spatiotemporal Single-cell Atlas of Peri-implant Soft Tissue Healing
NCT ID: NCT07279090
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
5 participants
INTERVENTIONAL
2025-12-20
2026-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Healing Abutment Gingival Healing Post-Implantation
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Stomatological Hospital Affiliated with Fujian Medical University
OTHER
Responsible Party
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Cheng Hui
Professor of Prosthodontics
Locations
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School and Hospital of Stomatology, Fujian Medical University
Fuzhou, Fujian, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20250829
Identifier Type: -
Identifier Source: org_study_id