NCT07574840

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
32mo left

Started Apr 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Apr 2026Dec 2028

First Submitted

Initial submission to the registry

April 9, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

1.7 years

First QC Date

April 9, 2026

Last Update Submit

May 3, 2026

Conditions

Periodontitis

Keywords

PeriodontitisDental pulp stem cells

Outcome Measures

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.

    Up to 12 month

Secondary Outcomes (1)

  • Alveolar Bone Regeneration Height (Alveolar Bone Level):

    Up to 12 month

Study Arms (1)

Allogeneic Dental Pulp Stem Cells

EXPERIMENTAL
Other: Allogeneic Dental Pulp Stem Cells for the Treatment of Periodontitis

Interventions

Allogeneic Dental Pulp Stem Cells for the Treatment of PeriodontitisOTHER

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.

Allogeneic Dental Pulp Stem Cells

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Wenjie Ren

    The First Affiliated Hospital of Xinxiang Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjie Ren

CONTACT

861393735407513937354075@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2026

First Posted

May 8, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

May 8, 2026

Record last verified: 2026-05