PeriodontisNCT07487272
Single-cell and Spatial Transcriptomic Profiling of Gingival Tissues in Aggressive and Chronic Periodontitis: Deciphering Cellular Heterogeneity and Inflammatory Microenvironment Features
An observational study of Periodontis and Aggressive Periodontitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontis, Aggressive Periodontitis
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2025to 30 Dec 2026
- Phase
- Observational
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This cross-sectional observational study will recruit 9 adults (n=3 per group) from the Department of Periodontology, Second Affiliated Hospital, Zhejiang University School of Medicine. All participants are already scheduled for routine tooth extraction or periodontal surgery, allowing incidental collection of a small gingival tissue sample (~1×3×1 mm) and 5 mL peripheral blood during standard care. No extra procedures are added. Aggressive Periodontitis (AP) Group (n=3) Age 20-35 years * 30% vertical bone loss at ≥2 sites on radiographs Stage III/IV, Grade C (2018 classification) With or without family history Minimal local factors (negligible calculus/trauma) Chronic Periodontitis (CP) Group (n=3) Age 30-40 years * 3 sites with probing depth ≥5 mm Stage I/II, Grade A/B (2018 classification) No family history Disease driven by plaque/calculus Healthy Controls (n=3) Age 20-40 years No significant bone loss on radiographs Clinically healthy periodontium (no gingivitis/periodontitis)
Who may be able to join
- 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.)
Show all 16Show fewer
- 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
Who cannot join
- 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
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, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang
Li Li Zhou, doctor, 18329193003, sophiazhou04@163.com
About this study
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:
Read more
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
- Conditions
- Periodontis, Aggressive Periodontitis
- Medical subject headings
- Aggressive Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| aggressive periodontitis group | Not described | |
| chronic periodontitis group | Not described | |
| control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Landscape of Cellular Heterogeneity in Periodontal Tissues
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.
Measured: 1 year
Identification of Key Molecular Markers and Signaling Pathways
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.
Measured: 1 year
Secondary outcomes (2)
Spatial Transcriptomic Expression Profiles
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.
Measured: 1 year
Genetic Variants Identified by Whole-Genome Sequencing
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start26 Dec 2025
- Primary completion26 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487272
- Sponsor's protocol ID
- 2025-1735
- Status last verified
- Dec 2025
- First submitted
- 17 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-cell and Spatial Transcriptomic Profiling of Gingival Tissues in Aggressive and Chronic Periodontitis: Deciphering Cellular Heterogeneity and Inflammatory Microenvironment Features
- ClinicalTrials.gov ID
- NCT07487272
- Acronym / sponsor ID
- 2025-1735
- Conditions
- Periodontis, Aggressive Periodontitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 26 Dec 2025 (actual)
- Primary completion
- 26 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 23 Mar 2026 (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.
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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| aggressive periodontitis group | – | – |
| chronic periodontitis group | – | – |
| control group | – | – |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This cross-sectional observational study will recruit 9 adults (n=3 per group) from the Department of Periodontology, Second Affiliated Hospital, Zhejiang University School of Medicine. All participants are already scheduled for routine tooth extraction or periodontal surgery, allowing incidental collection of a small gingival tissue sample (~1×3×1 mm) and 5 mL peripheral blood during standard care. No extra procedures are added. Aggressive Periodontitis (AP) Group (n=3) Age 20-35 years * 30% vertical bone loss at ≥2 sites on radiographs Stage III/IV, Grade C (2018 classification) With or without family history Minimal local factors (negligible calculus/trauma) Chronic Periodontitis (CP) Group (n=3) Age 30-40 years * 3 sites with probing depth ≥5 mm Stage I/II, Grade A/B (2018 classification) No family history Disease driven by plaque/calculus Healthy Controls (n=3) Age 20-40 years No significant bone loss on radiographs Clinically healthy periodontium (no gingivitis/periodontitis)
Key inclusion criteria (16 listed)
- 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.)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
2 secondary outcomes
Spatial Transcriptomic Expression Profiles
Time frame: 1 year
Genetic Variants Identified by Whole-Genome Sequencing
Time frame: 1 year
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 23 Mar 2026.
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Periodontis, Atherosclerosis Cardiovascular Disease
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?
An observational study of Periodontis and Aggressive Periodontitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 16 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 23 Mar 2026. 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 Li-li Zhou (+86 18329193003, sophiazhou04@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Landscape of Cellular Heterogeneity in Periodontal Tissues (time frame: 1 year). The study lists 2 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 23 Mar 2026.