Chronic Periodontitis
Conditions
Interventions
Single dose group:On the first day,based on initial periodontal therapy (supragingival cleansing, subgingival scaling and root planning), 1×10^7 human dental pulp stem cells injection will be given fo
Secondary dose group (low dose):On the first day,based on the initial periodontal treatment (supragingival cleaning, subgingival scraping, and root planning), 1×10 ^6 human pulp stem cells were inject
Secondary dose group (high dose):On the first day,based on the initial periodontal treatment (supragingival cleaning, subgingival scraping, and root planning), 1×10 ^7 human pulp stem cells were inje
Placebo control group:On the first day,based on the initial periodontal treatment (supragingival cleaning, subgingival scraping, and root planning), 0.6ml / dose of normal saline were injected locally
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-65 years old (including the boundary value), no gender limit; 2. Radiological detection of the periodontal defect site showed an angular bone defect; 3. The depth of exploration (PD) of the periodontal defect site was 4~8mm; 4. Good compliance, able to understand and cooperate with the corresponding inspection operation, willing to take drugs according to the requirements of the program and receive follow-up examination on time; 5. Volunteer to participate in the trial, understand, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with severe periodontal disease (alveolar bone resorption is more than two-thirds of the root length) and affecting the investigator's judgment; 2. For patients with baseline study, tooth loosening is 3 degrees (dental forceps holding method: only cheek and tongue motion is 1 degree; both cheek and tongue direction and near and far medium motion is 2 degrees; if vertical loosening is 3 degrees); 3. There of occlusal trauma in study teeth and affecting the investigator's judgment; 4. Previous surgery of periodontal defect sites and adjacent periodontal tissues; 5. Those who have been treated with non-steroidal anti-inflammatory drugs, steroids (steroid) hormones or other hormones (except local topical hormones) within 3 months prior to screening, and / or those who have previously used bisphosphonates; 6. Severe systemic infection within 3 months before screening; or using antibiotics within 72h before screening; 7. Uncontrollable hypertension within 1 month prior to screening (definition: systolic BP 160mmHg or diastolic BP 100mmHg while sitting after receiving the best antihypertensive treatment regimen); 8. Serious or uncontrollable diseases of various systems (heart, liver, kidney, respiratory, blood, endocrine, nervous, mental system); 9. People known to be allergic to any material used during the procedure (allergy, history of allergy to blood products); 10. Presence of any of the following laboratory findings at screening: ALT> 3 times ULN or serum total bilirubin> 1.5 times ULN; blood creatinine> 1.5 times ULN; international standardized ratio (INR) 1.5 times ULN or activated partial thromboplastin time (APTT) 1.5 times ULN (except for patients on anticoagulation) or Hb <80g /; PLT <75.0109 / L; 11. Positive tests at screening for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), and treponema pallidum antibody (TP-Ab); 12. Women in pregnancy and lactation; 13. Participants and their partners had a birth plan within 6 months from screening to the end of the trial or did not agree to use effective non-pharmacological contraception during the trial; 14. Subjects participating in any other clinical trial within 3 months prior to screening; 15. Those with a history of smoking addiction within 12 months before screening (10 cigarettes per day); 16 The Investigator considers the subject otherwise inappropriate to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Periodontal bone defect height;Incidence of Treatment-Emergent Adverse Event; | — |
Secondary
| Measure | Time frame |
|---|---|
| probing pocket depth;clinical attachment loss;bleeding index;gingival recession;Tooth Mobility; | — |
Countries
China
Contacts
Public ContactWang Xiao
Peking University Third Hospital
Outcome results
None listed