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

Study of Local Periodontal Regeneration of Chronic Periodontal Disease Patients Receiving Allogeneic Human Dental Pulp Stem Cells Injection Therapy

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.

Study Overview

• Status: Unknown
• Conditions: Periodontal Diseases
• Intervention / Treatment: Genetic: DPSC injection; Other: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Songlin Wang, Ph.D; Phone Number: +86 13601324511; Email: slwang@ccmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Capital Medical University School of Stomatology
      • Contact: Jingchao Hu, Ph.D; Phone Number: +86 13716607107; Email: hujingchao117@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DPSC injection; 20 patients will receive DPSC injection（1000000 cells/ 0.5ml） at the local periodontal defects immediately after periodontal scaling and root planing.	Genetic: DPSC injection; A 0.5ml saline preparation containing 1000000 DPSCs were injected at the local periodontal defects immediately after periodontal scaling and root planing.
Placebo Comparator: Placebo control; 20 patients will receive saline injection at the local periodontal defects immediately after periodontal scaling and root planing.	Other: Placebo; A 0.5ml saline preparation were injected at the local periodontal defects immediately after periodontal scaling and root planing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline alveolar bone volume examined by computed tomography(CT) at 1 year	Baseline and 1 year after intervention.

Secondary Outcome Measures

Outcome Measure	Time Frame
Quigley-Hein plaque index (QHI)	Baseline
Change from Baseline Bleeding on probing (BoP) at 1 year	Baseline and 1 year after intervention.
Change from Baseline Probing depth (PD) at 1 year	Baseline and 1 year after intervention.
Change from Baseline Clinical attachment level (CAL) at 1 year	Baseline and 1 year after intervention

Collaborators and Investigators

• Sponsor: Songlin Wang
• Investigators: Study Director: Songlin Wang, Ph.D, Beijing Key Laboratory of Tooth Regeneration and Function Reconstruction， Capital Medical University School of Stomatology

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: June 10, 2015
• First Submitted That Met QC Criteria: August 13, 2015
• First Posted (Estimate): August 14, 2015

Study Record Updates

• Last Update Posted (Estimate): August 14, 2015
• Last Update Submitted That Met QC Criteria: August 13, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Bone Regeneration; Dental Pulp Stem Cell; Periodontal Diseases
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontitis; Periodontal Diseases; Chronic Periodontitis
• Other Study ID Numbers: CapitalMedicalU-1