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NCT Number: NCT07487272

Single-cell and Spatial Transcriptomic Profiling of Gingival Tissues in Aggressive and Chronic Periodontitis: Deciphering Cellular Heterogeneity and Inflammatory Microenvironment Features

The goal of this observational study is to investigate cellular heterogeneity and inflammatory microenvironment features in gingival tissues from patients with aggressive periodontitis compared to chronic periodontitis and healthy controls, using single-cell and spatial transcriptomics combined with whole-genome sequencing.

The main question(s) it aims to answer are:

What are the differences in cellular composition, mesenchymal stem cell subpopulations, and gene expression profiles between aggressive periodontitis, chronic periodontitis, and healthy gingival tissues? Which key molecular markers, signaling pathways, and spatially resolved microenvironment patterns distinguish aggressive periodontitis from the more common chronic form? Are there disease-specific genetic variants associated with aggressive periodontitis identified through whole-genome sequencing of peripheral blood DNA?

Participants (already scheduled for tooth extraction or periodontal surgery as part of routine clinical care) will undergo:

Standard clinical periodontal examination and CBCT imaging Collection of a small gingival tissue sample (~1×3×1 mm) during the planned extraction/surgery under local anesthesia Collection of 5 mL peripheral blood for DNA extraction No additional intervention, treatment, or follow-up visit is required beyond routine dental care.

Last updated: December 23, 2025

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

Location status: Recruiting

Location contact

Li Li Zhou, doctor

CONTACT

[email protected]

18329193003

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Aggressive Periodontitis Patients:

  • Aged 20-35 years
  • Radiographic evidence of at least 30% vertical bone loss at ≥2 tooth sites
  • Can be classified as Stage III/IV, Grade C periodontitis according to the 2018 new classification of periodontitis
  • With or without family history of periodontitis
  • No significant local contributing factors (e.g., calculus, occlusal trauma, etc.)

Chronic Periodontitis Patients:

  • Aged 30-40 years
  • ≥3 sites with probing depth ≥5 mm
  • Can be classified as Stage I/II, Grade A/B periodontitis according to the 2018 new classification of periodontitis
  • No significant family history
  • Disease predominantly driven by local factors (dental plaque, calculus, etc.)

Healthy Controls:

  • Aged 20-40 years
  • Radiographic examination shows no significant alveolar bone loss
  • Clinically cannot be diagnosed with gingivitis or periodontitis

Exclusion criteria

  • Use of antibiotics within the past 3 months
  • Smoking >10 cigarettes per day
  • Uncontrolled severe diabetes (HbA1c level ≥6.7%)
  • Planning pregnancy, currently pregnant, or breastfeeding
  • Alcohol or drug addiction
  • Long-term use of immunosuppressive agents
  • Infectious diseases such as hepatitis or AIDS/HIV
  • History of malignant tumor, radiotherapy, or chemotherapy within the past 5 years

Treatment and study plan

Primary outcomes

  1. Landscape of Cellular Heterogeneity in Periodontal Tissues

    Time frame: 1 year

    Single-cell RNA sequencing (scRNA-seq) will be used to evaluate the cellular heterogeneity of gingival tissues from patients with aggressive periodontitis (AP group), chronic periodontitis (CP group), and healthy controls, with a particular focus on mesenchymal stem cells. This includes identification of cell subpopulations and quantification of these subpopulations based on gene expression profiles.

  2. Identification of Key Molecular Markers and Signaling Pathways

    Time frame: 1 year

    To discover differentially expressed molecular markers and signaling pathways between the AP group, CP group, and healthy group. By integrating single-cell RNA sequencing and spatial transcriptomics data, the analysis will identify potential therapeutic targets.

Secondary outcomes

  1. Spatial Transcriptomic Expression Profiles

    Time frame: 1 year

    Evaluation of the spatial distribution patterns of gene expression in gingival tissues from the aggressive periodontitis (AP) group, chronic periodontitis (CP) group, and healthy controls, as well as treatment-induced spatial changes. Spatial transcriptomics technology will be used to map cell-cell interactions and differences in the microenvironment.

  2. Genetic Variants Identified by Whole-Genome Sequencing

    Time frame: 1 year

    Through whole-genome resequencing (WGS) of peripheral blood DNA, identification of genetic susceptibility variants associated with aggressive periodontitis and chronic periodontitis, with a particular focus on variants related to familial aggregation, genetic predisposition, disease progression, and treatment response.

Study contacts

Contact information is provided by the study sponsor or research team.

Li-li Zhou

CONTACT

[email protected]

+86 18329193003

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 23, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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