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Treatment of periodontitis with dental follicle stem cells

Evaluation of the safety and efficacy of allogeneic dental follicle stem cells in the treatment of periodontal bone defects: a parallel group, prospective, randomized controlled human multi-center clinical study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054134
Enrollment
Unknown
Registered
2021-12-09
Start date
2021-12-09
Completion date
Unknown
Last updated
2022-11-07

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

Conditions

Periodontal disease

Interventions

treatment group:100ul dental follicle stem cells are implanted in the periodontal pocket
control group:100ul normal saline is injected into the periodontal pocket

Sponsors

Chengdu Shiliankangjian Biotechnology Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Adults in the age range of 30 to 45 years old; 2. The subjects' clinical probing and imaging examinations found that there were two- or three-wall subosseous pockets with PD>=5mm, or I/II degree bifurcation lesions; 3. The looseness of the affected tooth in the subject's operation area is <= II degree, and the width of the attached gingiva is sufficient; 4. The subjects gave informed consent, understood the purpose of the trial, and were able to cooperate with the completion of the trial and at least 1-year postoperative routine follow-up as required; 5. Subjects were able to achieve good self-plaque control, including correct brushing and flossing.

Exclusion criteria

Exclusion criteria: 1. Failure to maintain proper oral hygiene during the introduction period; 2. Pregnant women, lactating women, and women planning to become pregnant during this study; 3. A history of oral cancer or HIV; 4. The study teeth have a history of periodontal surgery; 5. Clinical or radiological findings of untreated acute infection, apical lesions, root fractures, severe root deformities, unremovable cementum/enamel protrusions, cementoenamel junctions, or root surfaces at the surgical site Untreated caries, metal restorations or restorations subgingival and/or restoration margins at or below the cementoenamel junction; 6. In the past 6 months, chewing smokeless tobacco, smoking >=1 times a week, or smoking >=10 cigarettes per day; 7. Suffering from mental cognitive impairment; 8. Patients with malignant tumor or a history of malignant tumor; 9. Suffering from diabetes or glycated hemoglobin >= 6.5%; 10. Take calcium antagonists within four weeks before surgery; 11. Use of adrenal corticosteroids within four weeks before surgery; 12. Taking medicines not specified for observation during the observation period of the subjects; 13. Have allergies or are allergic to biologically active products or drugs; 14. Within 30 days of surgery, the patient received treatment from other studies; 15. Members of the research team and their families; 16. Patients with immune system abnormalities (such as autoimmune diseases); 17. Patients with systemic diseases (such as liver, kidney, blood system diseases, Sjogren's syndrome, Behcet's disease, etc.) that may cause or aggravate oral problems; 18. Any other factors that may cause trial bias.

Design outcomes

Primary

MeasureTime frame
bone defect depth;bone defect depth;bone defect depth and width;

Secondary

MeasureTime frame
clinical attachment level;probing depth;recession of gingiva;

Countries

China

Contacts

Public ContactTian Weidong

West China Hospital of Stomatology, Sichuan University

drtwd@sina.com+86 13608053216

Outcome results

None listed

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