Human Dental Pulp Mesenchymal Stem Cells for the Treatment of Chronic Periodontitis Patients

Launched by PEKING UNIVERSITY THIRD HOSPITAL · Jun 20, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for chronic periodontitis, which is a serious gum disease that affects many people. The study aims to find out how effective and safe different ways of giving human dental pulp mesenchymal stem cells are in helping patients with this condition. Stem cells are special cells that can develop into different types of cells in the body and may help repair damaged tissue in the gums.

To be eligible for this trial, participants need to be between 18 and 65 years old and have specific signs of gum disease, like a certain level of gum pocket depth. They should also be willing to attend all scheduled visits and follow the treatment plan. Participants can expect to receive treatment and undergo regular check-ups to monitor their progress. It's important to note that people with more severe gum disease, certain health issues, or those who have recently undergone specific treatments may not qualify for this study. Overall, this trial offers hope for improving treatment options for those suffering from chronic periodontitis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Participants are eligible to be included in the study only if all of the following criteria apply:
• • 1)18 to 65 years old (including threshold), unlimited gender; 2)Radiological examination of the periodontal defect site shows angular bone defect; 3)The probing depth (PD) at the periodontal defect site is 4 to 8 mm at baseline; 4)Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures; 5)Voluntarily participate in the clinical study, understand and sign the informed consent;
• Exclusion Criteria:
• * Participants are excluded from the study if any of the following criteria apply:
• • 1. Participants with severe periodontal diseases (alveolar bone resorption exceeds two-thirds of the tooth root length) which affect the investigator's judgment;
• • 2. The grade of studied tooth looseness ≥ grade 3 at baseline (only buccolingual movement is defined as grade 1; buccolingual and mesiodistal movement is grade 2; vertical loosening is grade 3);
• • 3. The studied tooth with occlusal trauma which affect the investigator's judgment;
• • 4. Participants with surgical treatment of previous periodontal defect sites and adjacent periodontal tissues;
• • 5. Participants with non-steroid anti-inflammatory drug, steroid hormone therapy, and/or other hormone (except topical hormones) treatment within past 3 months of the screening visit, and/or previous use of bisphosphonates;
• • 6. Participants with severe systemic infection within past 3 months of the screening visit, or antibiotics treatment within past 72h of the screening visit;
• • 7. Participants with uncontrolled hypertension within 1 month before screening (defined as sitting systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg after receiving the optimal antihypertensive therapy);
• • 8. Participants with severe or uncontrolled diseases in any system (cardiac, hepatic, renal, respiratory, hematologic, endocrine, nervous, or psychiatric);
• • 9. Participants are known to be allergic to any materials that may be used during surgery (allergy-prone constitution or history of allergy to blood products);
• • 10. Any of the following abnormalities in clinical laboratory tests at screening: ALT \> 3 ULN, total bilirubin \> 1.5 ULN, serum creatinine \> 1.5 ULN, international normalized ratio (INR) ≥ 1.5 ULN or activated partial thromboplastin time (APTT) ≥ 1.5 ULN (except for patients receiving anticoagulation therapy), Hb \< 80 g/L, or PLT \< 75.0×109/L;
• • 11. Positive result for any of the following tests at screening: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (TP-Ab);
• • 12. Females who are pregnant or breastfeeding;
• • 13. Participants and their partners who plan to conceive or do not agree to use the effective non-pharmacological method of contraceptive during the trial from screening visit to 6 months after the end of the trial;
• • 14. Participants participated in other clinical studies within past 3 months of the screening visit;
• • 15. Participants with a history of smoking addiction within past 12 months of the screening visit (the number of cigarettes smoked per day ≥ 10); Other circumstances deemed inappropriate by the investigator.