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

Primary Purpose

Periodontal Diseases

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
DPSC injection
Placebo
Sponsored by
Songlin Wang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring Periodontal Diseases, Bone Regeneration, Dental Pulp Stem Cell

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Capital Medical University School of StomatologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DPSC injection

Placebo control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from Baseline alveolar bone volume examined by computed tomography(CT) at 1 year

Secondary Outcome Measures

Quigley-Hein plaque index (QHI)
Change from Baseline Bleeding on probing (BoP) at 1 year
Change from Baseline Probing depth (PD) at 1 year
Change from Baseline Clinical attachment level (CAL) at 1 year

Full Information

First Posted
June 10, 2015
Last Updated
August 13, 2015
Sponsor
Songlin Wang
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1. Study Identification

Unique Protocol Identification Number
NCT02523651
Brief Title
Periodontal Regeneration of Chronic Periodontal Disease Patients Receiving Stem Cells Injection Therapy
Official Title
Study of Local Periodontal Regeneration of Chronic Periodontal Disease Patients Receiving Allogeneic Human Dental Pulp Stem Cells Injection Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Songlin Wang

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
Keywords
Periodontal Diseases, Bone Regeneration, Dental Pulp Stem Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DPSC injection
Arm Type
Experimental
Arm Description
20 patients will receive DPSC injection（1000000 cells/ 0.5ml） at the local periodontal defects immediately after periodontal scaling and root planing.
Arm Title
Placebo control
Arm Type
Placebo Comparator
Arm Description
20 patients will receive saline injection at the local periodontal defects immediately after periodontal scaling and root planing.
Intervention Type
Genetic
Intervention Name(s)
DPSC injection
Intervention Description
A 0.5ml saline preparation containing 1000000 DPSCs were injected at the local periodontal defects immediately after periodontal scaling and root planing.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
A 0.5ml saline preparation were injected at the local periodontal defects immediately after periodontal scaling and root planing.
Primary Outcome Measure Information:
Title
Change from Baseline alveolar bone volume examined by computed tomography(CT) at 1 year
Time Frame
Baseline and 1 year after intervention.
Secondary Outcome Measure Information:
Title
Quigley-Hein plaque index (QHI)
Time Frame
Baseline
Title
Change from Baseline Bleeding on probing (BoP) at 1 year
Time Frame
Baseline and 1 year after intervention.
Title
Change from Baseline Probing depth (PD) at 1 year
Time Frame
Baseline and 1 year after intervention.
Title
Change from Baseline Clinical attachment level (CAL) at 1 year
Time Frame
Baseline and 1 year after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Songlin Wang, Ph.D
Phone
+86 13601324511
Email
slwang@ccmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Songlin Wang, Ph.D
Organizational Affiliation
Beijing Key Laboratory of Tooth Regeneration and Function Reconstruction， Capital Medical University School of Stomatology
Official's Role
Study Director
Facility Information:
Facility Name
Capital Medical University School of Stomatology
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingchao Hu, Ph.D
Phone
+86 13716607107
Email
hujingchao117@hotmail.com

12. IPD Sharing Statement

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

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