Allogeneic Dental Pulp Stem Cells for the Treatment of Periodontitis (NCT07574840) | Clinical Trial Compass
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Allogeneic Dental Pulp Stem Cells for the Treatment of Periodontitis
30 participantsStarted 2026-04-15
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* 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).
* Age and General Condition: Typically aged 18-70 years, in good general health, and able to complete the 12-month follow-up.
* Oral Hygiene Awareness: Subjects are willing to receive conventional periodontal basic treatment (SRP) and demonstrate a good willingness to maintain oral hygiene (e.g., plaque index controlled at a low level).
Exclusion Criteria:
* 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 loca…
What they're measuring
1
Change in Probing Pocket Depth (PPD)
Timeframe: Up to 12 month
Trial details
NCT IDNCT07574840
SponsorThe First Affiliated Hospital of Xinxiang Medical College