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A Randomized, Open-Lable, Controlled Clinical Study 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, Open-Lable, Controlled Clinical Study 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
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051466
Enrollment
Unknown
Registered
2021-09-24
Start date
2020-05-22
Completion date
Unknown
Last updated
2022-06-20

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

Conditions

Chronic Periodontitis

Interventions

Normal saline control group:Immediately after the basic periodontal treatment is completed, a bilateral multi-point injection of 0.6ml of normal saline is performed on a single tooth of the patient
Stem Cell Therapy Group:Immediately after the completion of basic periodontal treatment, bilateral multi-point injections were given to a single tooth of the subject, and the treatment dose was 1×10^7
Stem cell secondary administration group:Immediately after basic periodontal treatment is completed, the subject will be given bilateral multi-point injections to a single tooth. The treatment dose is

Sponsors

Beijing Stomatological Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-65 years; (2) Volunteer to participate in this clinical study and sign the "Informed Consent"; (3) Radiological examination of periodontal defect site showed wedge-shaped bone defect; (4) The probing depth (PD) of the periodontal defect site is 4-8mm.

Exclusion criteria

Exclusion criteria: (1) Blood pressure of subjects with hypertension within 1 month before surgery: systolic blood pressure >= 180mmHg or diastolic blood pressure >= 110mmHg; (2) Patients with systemic system diseases (malignant tumor subjects or those with positive tumor tests during the screening process, diabetes subjects, heart disease causing heart failure, myocardial infarction within six months; angina symptoms within six months; congenital heart sick.); (3) Those who have used non-steroidal anti-inflammatory drugs, steroid (steroid) hormone therapy, and/or long-term use of hormones, and those who have used bisphosphonates within 3 months before surgery; (4) Systemic infection; (5) Those who have received surgical treatment at the site of periodontal defect and adjacent periodontal tissue; (6) Those who are known to be allergic to any materials used during surgery; (allergic, have a history of allergies to blood products;) (7) Patients with severe periodontal disease (alveolar bone resorption exceeds two-thirds of the root length); (8) Patients with severe liver and kidney dysfunction; (9) People with bleeding tendency or coagulation dysfunction (WBC count WBC 10 cigarettes/day); (15) Those whose expected survival period is less than 12 months; (16) Other situations where the researcher thinks it is inappropriate to participate.

Design outcomes

Primary

MeasureTime frame
Periodontal attachment level;

Secondary

MeasureTime frame
Changes in the height of the periodontal defect;Change in average density of alveolar ridge;Periodontal probing depth;Exploratory bleeding index;

Countries

China

Contacts

Public ContactYi Liu

Beijing Stomatological Hospital, Capital Medical University

lililiuyi@163.com+86 10-57099449

Outcome results

None listed

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