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

August 13, 2015 updated by: Songlin Wang

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Capital Medical University School of Stomatology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Baseline and 1 year after intervention.
Baseline and 1 year after intervention.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CapitalMedicalU-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Periodontal Diseases

Clinical Trials on DPSC injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe