Periodontal Regeneration of Chronic Periodontal Disease Patients Receiving Stem Cells Injection Therapy

Songlin Wang

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Periodontal Diseases

Treatments: Other: Placebo; Genetic: DPSC injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02523651

CapitalMedicalU-1

Details and patient eligibility

About

The purpose of this study is to evaluate the safety of clinical injection of allogeneic human dental pulp stem cell(DPSC) in local infected periodontal tissue and determine whether injection of allogeneic DPSC is a effective way in the treatment of chronic periodontal disease.

Full description

This study will involve 40 patients who were diagnosed as chronic periodontitis will receive periodontal scaling and root planing. Patients will randomly be divided at the base line into two groups.In test group, 20 chronic periodontitis patients will be treated using local DPSC injection. Whereas, a control group will contain 20 patients who will be treated using placebo. Clinical examination including Quigley-Hein plaque index (QHI), bleeding on probing (BoP), probing depth (PD), clinical attachment level (CAL), and gingival recession (GR) will be perform in different time points during the study. Radiographic and clinical examination will be carried out during the late healing phase up to 12 months post operation.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of periodontal disease will be based on clinical assessment of:

  • Quigley-Hein index (QHI)
  • Bleeding on Probing (BoP)
  • Pocket Probing Depth (PD)
  • gingival recession (GR)
  • Clinical Attachment Level (CAL)
  • furcation involvement,and
  • radiographical assessment. All patients at the base line of this study should have been received the initial treatment and reached the qualified level of oral hygiene to be included in the next stage.

Exclusion criteria

• Pregnant,
• smokers,
• immunosuppressed or diabetes patients,
• patients exhibit gingival hypertrophy,
• require premedication, and
• who have been taking systemic anti-inflammatory medications, or
• have taken antibiotics or
• received periodontal instrumentation within 6 months prior to the study, will be excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

DPSC injection

Experimental group

Description:

20 patients will receive DPSC injection（1000000 cells/ 0.5ml） at the local periodontal defects immediately after periodontal scaling and root planing.

Treatment:

Genetic: DPSC injection

Placebo control

Placebo Comparator group

Description:

20 patients will receive saline injection at the local periodontal defects immediately after periodontal scaling and root planing.

Treatment:

Other: Placebo