Skip to content

A Randomized, Double-Blind, Blank Controlled, Dose-Escalation Clinical Trial to Evaluate the Safety and Tolerability of Initial periodontal therapy Combined with Human Dental Pulp Stem Cell Injection in the Treatment of Chronic Periodontitis

A Randomized, Double-Blind, Blank Controlled, Dose-Escalation Clinical Trial to Evaluate the Safety and Tolerability of Initial periodontal therapy Combined with Human Dental Pulp Stem Cell Injection in the Treatment of Chronic Periodontitis

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049178
Enrollment
Unknown
Registered
2021-07-24
Start date
2021-07-28
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

Chronic Periodontitis

Interventions

Experimental group1:Based on initial periodontal therapy (supragingival cleansing, subgingival scaling and root planning), 1×10^6 human dental pulp stem cells injection will be given for a single loc
Experimental group2:Based on initial periodontal therapy (supragingival cleansing, subgingival scaling and root planning), 5×10^6 human dental pulp stem cells injection will be given for a single loca
Experimental group3:Based on initial periodontal therapy (supragingival cleansing, subgingival scaling and root planning), 1×10^7 human dental pulp stem cells injection will be given for a single loca
Experimental group4:Based on initial periodontal therapy (supragingival cleansing, subgingival scaling and root planning), 1×10^7 human dental pulp stem cells injection will be given for a single loca
Experimental group5:Based on initial periodontal therapy (supragingival cleansing, subgingival scaling and root planning), 1×10^7 human dental pulp stem cells injection will be given for a single loca

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 to 65 years(including critical value), gender is not limited; 2. Thed radiological detection of the periodontal defect site showed a vertical bone defect, and the probing depth (PD) of the periodontal defect site was 4-8 mm; 3. Voluntarily participate in this clinical study, understand and sign the informed consent form, and voluntarily abide by the relevant regulations of this study during the study period and within 18 months after the end of the study.

Exclusion criteria

Exclusion criteria: 1. Subjects with severe periodontal disease (alveolar bone resorption generally exceeds two-thirds of the root length) and affects the judgment of research teeth 2. The degree of loosening of the study teeth is >=2 degrees (the dental forceps clamping method only has a buccolingual movement of 1 degree; buccolingual and mesiodistal movements are 2 degrees; if there is vertical loosening, it is 3 degrees) ; 3. Those who have received surgical treatment on the site of periodontal bone defect and adjacent periodontal tissue in the past; 4. Those who used non-steroidal anti-inflammatory drugs, steroid (steroid) hormone therapy within 3 months before screening, and/or those who used hormones (except topical hormones) within 3 months before screening, 3 months before screening Internal use of bisphosphonates; 5. Patients with severe systemic infection within 3 months before screening; or those who used antibiotics within 72 hours before screening; Co-morbidities/history: 6. Uncontrolled hypertension within 1 month before screening (definition: after receiving the best antihypertensive treatment regimen, the subject's systolic blood pressure >=160mmHg or diastolic blood pressure >=95mmHg when sitting); 7. Patients with systemic diseases (including but not limited to: patients with malignant tumors or those with positive tumor test during screening, diabetic patients, patients with heart failure caused by heart disease, patients with myocardial infarction within six months before screening, and angina pectoris within six months before screening Symptoms and congenital heart disease patients, etc.); Allergy history: 8. Those who are known to be allergic to any materials used in the course of treatment; 9. Allergic constitution, past history of allergy to blood products; 10. Laboratory tests (any item is met): abnormal liver function: ALT>80U/L or AST>70U/L, abnormal renal function: serum creatinine (picric acid method)>97umol/L; 11. Those with bleeding tendency or coagulation dysfunction (international normalized ratio (INR) >= 1.5 times ULN, or activated partial thromboplastin time (APTT) >= 1.5 times ULN (except for patients receiving anticoagulant therapy)) or severe Hematological diseases (such as grade 3 or higher anemia (Hb= 10 cigarettes); 17. Subjects with mental or consciousness disorders; 18. Subjects who have participated in other clinical studies within 3 months before screening; 19. Other circumstances that the researcher considers inappropriate to participate.

Design outcomes

Primary

MeasureTime frame
Vital signs;Blood routine;Liver and kidney function;Immunological examination;Urine and stool routine;electrocardiogram;Inflammatory markers;Incidence of Treatment-Emergent Adverse Event;

Secondary

MeasureTime frame
probing pocket depth;clinical attachment loss;bleeding index;gingival recession;Tooth Mobility;Periodontal bone defect height;

Countries

China

Contacts

Public ContactWang Xiao

Peking University Third Hospital

bysywangxiao@163.com+86 10 82266334

Outcome results

None listed

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