About this trial
The overall objective of this study is to evaluate the safety and efficacy of allogeneic human dental pulp stem cells (DPSCs) injected for the treatment of chronic periodontitis in humans. It aims to develop a stem cell injection therapy that promotes the regeneration of periodontal soft and hard tissues through a non-invasive (minimally invasive) procedure, thereby replacing traditional traumatic periodontal surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Disease Diagnosis: Clinically diagnosed with chronic periodontitis (typically Stage III or IV according to the latest periodontal disease classification).
Target Tooth Requirements: At least two non-adjacent periodontal pockets with a Probing Pocket Depth (PPD) ≥5 mm.
Clinical Attachment Level (CAL) loss ≥3 mm.
Evidence of significant alveolar bone resorption on X-ray or CBCT (bone loss exceeding one-third of the root length).
Disqualifiers
Systemic Diseases: Presence of severe, uncontrolled systemic diseases (e.g., diabetes with HbA1c >7%, active hepatitis, tuberculosis). History of malignancy or immunodeficiency diseases (due to the proliferative potential of stem cells, cancer risk must be strictly excluded).
Local Interfering Factors: Target teeth with severe mobility (Grade III mobility) or non-restorable residual crowns/roots. Received periodontal surgical treatment or systemic antibiotics within the past 3 months.
Special Populations and Habits: Heavy smokers (typically defined as smoking >10 cigarettes per day), as smoking significantly inhibits the regenerative effect of stem cells and local blood supply. Pregnant or breastfeeding women. Individuals allergic to any components of the study preparation (e.g., specific biological carriers).
Trial design
Single group
Treatments tested in this trial
Allogeneic Dental Pulp Stem Cells for the Treatment of Periodontitis
Other interventionThe overall objective of this study is to evaluate the safety and efficacy of allogeneic human dental pulp stem cells (DPSCs) injected for the treatment of chronic periodontitis in humans. It aims to develop a stem cell injection therapy that promotes the regeneration of periodontal soft and hard tissues through a non-invasive (minimally invasive) procedure, thereby replacing traditional traumatic periodontal surgery.
Treatment groups
Trial outcomes
Primary outcomes
Change in Probing Pocket Depth (PPD)
The distance from the bottom of the periodontal pocket to the gingival margin is measured using a standardized periodontal probe.
Secondary outcomes
Alveolar Bone Regeneration Height (Alveolar Bone Level):
Cone beam computed tomography (CBCT) scanning is used to quantitatively calculate the increase in bone height and changes in bone density in the vertical bone resorption area.
Locations
Sponsors and contacts
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