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The clinical translation study of using periodontal tissue-specific ECM to expand hPDLSCs in vitro for the treatment of periodontal intrabony defect

The clinical translation study of using periodontal tissue-specific ECM to expand hPDLSCs in vitro for the treatment of periodontal intrabony defect - ECM expand hPDLSCs to treat periodontal intrabony defect

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102767
Enrollment
Unknown
Registered
2025-05-20
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intrabony pocket periodontal defects

Interventions

Experimental group:implant bone powder and hPDLSCs/ECM composite in periodontal intrabony defect and cover with a biological membrane
Control group:implant bone powder in periodontal intrabony defect and cover with a biological membrane

Sponsors

The Third Affiliated Hospital of Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. The participant must sign an informed consent form, indicating that they have been fully briefed on the nature of the study and agree to participate. 2. Participants must be between 18 and 65 years old. 3. Participants must have at least one tooth site with a two-wall or three-wall bone defect caused by periodontitis (intrabony pocket greater than 3mm). 4. As determined by the researchers, the participant's condition should be suitable for flap surgery plus bone grafting, with no more than five tooth sites requiring bone grafting. 5. Researchers must assess that the affected teeth can be preserved for at least 3 to 5 years following treatment.

Exclusion criteria

Exclusion criteria: 1. Individuals whom the researchers judge to be unlikely to adhere to the study procedures. 2. Presence of uncontrollable pathological processes within the oral cavity. 3. Known or suspected malignant tumors. 4. History of radiation therapy to the head and neck area. 5. History of chemotherapy within 5 years prior to the surgery. 6. Any systemic or local diseases, as determined by the researchers, that may affect post-operative healing. 7. Diagnosed with uncontrolled diabetes mellitus. 8. Use of steroids or other medications that could potentially impact post-operative healing. 9. Smoking more than 10 cigarettes per day. 10. Alcohol abuse or drug use. 11. Participation in other clinical studies simultaneously or within a few weeks prior to enrollment. 12. Pregnant women or those planning to become pregnant during the study period. 13. Ineligibility for Bone Grafting: Patients who do not meet the clinical conditions necessary for bone grafting. 14. Patients with severe periodontitis requiring bone grafting in more than five tooth sites.

Design outcomes

Primary

MeasureTime frame
bone-defect depth;

Secondary

MeasureTime frame
clinical attachment level;probing depth;bleeding on probing;

Countries

China

Contacts

Public ContactJunjie Wu

The Third Affiliated Hospital of Air Force Medical University

fmmuwu@fmmu.edu.cn+86 151 2906 2108

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026