The Safety and Tolerability of Initial Periodontal Therapy Combined With Human Dental Pulp Stem Cell Injection in the Treatment of Chronic Periodontitis
NCT04983225 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2023-05-31
Summary
The principal objective of this trial is to investigate the safety and tolerability of human dental pulp stem cells injection in the treatment of chronic periodontitis. The secondary objective is to provide the basis for dosage regimen for further clinical trials and to evaluate the preliminary efficacy.
Conditions
- Periodontitis
Interventions
- DRUG
-
Human Dental Pulp Stem Cells
Investigational drugs: based on initial periodontal therapy (supragingival cleansing, subgingival scaling and root planning), human dental pulp stem cell injection will be given for a single local injection;
- OTHER
-
Saline solution
Blank control: initial Basal periodontal therapy (supragingival cleansing, subgingival scaling and root planning) followed by a single local injection of normal saline.
Sponsors & Collaborators
-
Capital Medical University
collaborator OTHER -
Peking University Third Hospital
lead OTHER
Principal Investigators
-
Xiao Wang, Master · Department of Stomatology, Peking University Third Hospital, Beijing, China.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-07-31
- Primary Completion
- 2024-07-31
- Completion
- 2024-08-31
Countries
- China
Study Locations
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