Allogeneic Dental Pulp Stem Cells for the Treatment of Periodontitis

ConditionPeriodontitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe First Affiliated Hospital of Xinxiang Medical College

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Allogeneic Dental Pulp Stem Cells for the Treatment of Periodontitis

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Allogeneic Dental Pulp Stem CellsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 12 month

Secondary outcomes

1

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.

Time frame
Up to 12 month

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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