Actively Recruiting
Human Dental Pulp Mesenchymal Stem Cells for the Treatment of Chronic Periodontitis Patients
Led by Peking University Third Hospital · Updated on 2024-05-29
204
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
Sponsors
P
Peking University Third Hospital
Lead Sponsor
C
Capital Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary objective:To evaluate the efficacy of different administration protocols of human dental pulp mesenchymal stem cells for the treatment of chronic periodontitis patients. The secondary objective:To evaluate the safety of different administration protocols of human dental pulp mesenchymal stem cells for the treatment of chronic periodontitis patients. The exploratory objective:To investigate the effects of human dental pulp mesenchymal stem cells on biomarkers in gingival crevicular fluid in chronic periodontitis patients.
CONDITIONS
Official Title
Human Dental Pulp Mesenchymal Stem Cells for the Treatment of Chronic Periodontitis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years, any gender
- Radiological evidence of angular bone defect at the periodontal defect site
- Probing depth of 4 to 8 mm at the periodontal defect site at baseline
- Willingness and ability to comply with all scheduled visits, treatments, lab tests, and study procedures
- Voluntary participation with understanding and signing of informed consent
You will not qualify if you...
- Severe periodontal disease with alveolar bone loss exceeding two-thirds of the tooth root length
- Tooth looseness grade 3 or higher at baseline
- Occlusal trauma affecting the studied tooth
- Prior surgical treatment of periodontal defect sites and adjacent tissues
- Use of non-steroidal anti-inflammatory drugs, steroid hormones, or other hormones (except topical) within 3 months before screening, or previous bisphosphonate use
- Severe systemic infection within 3 months before screening or antibiotic use within 72 hours before screening
- Uncontrolled hypertension within 1 month before screening (systolic ≥160 mmHg or diastolic ≥100 mmHg despite treatment)
- Severe or uncontrolled diseases of cardiac, liver, kidney, respiratory, blood, endocrine, nervous, or psychiatric systems
- Known allergies to materials used during surgery or blood products
- Abnormal lab tests at screening including elevated ALT, bilirubin, creatinine, INR, APTT, low hemoglobin, or low platelets
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis antibodies at screening
- Pregnant or breastfeeding females
- Participants or partners planning pregnancy or not agreeing to use effective contraception during the study and for 6 months after
- Participation in other clinical studies within 3 months before screening
- History of smoking addiction (≥10 cigarettes/day) within 12 months before screening
- Other conditions deemed inappropriate by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijng, China, 100191
Actively Recruiting
Research Team
X
Xiao Wang, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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