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Trial record 1 of 1 for:    NCT02523651
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Periodontal Regeneration of Chronic Periodontal Disease Patients Receiving Stem Cells Injection Therapy

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ClinicalTrials.gov Identifier: NCT02523651
Recruitment Status : Unknown
Verified August 2015 by Songlin Wang, Capital Medical University.
Recruitment status was:  Recruiting
First Posted : August 14, 2015
Last Update Posted : August 14, 2015
Sponsor:
Information provided by (Responsible Party):
Songlin Wang, Capital Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Periodontal Diseases Genetic: DPSC injection Other: Placebo Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Local Periodontal Regeneration of Chronic Periodontal Disease Patients Receiving Allogeneic Human Dental Pulp Stem Cells Injection Therapy
Study Start Date : December 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline alveolar bone volume examined by computed tomography(CT) at 1 year [ Time Frame: Baseline and 1 year after intervention. ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02523651


Contacts
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Contact: Songlin Wang, Ph.D +86 13601324511 slwang@ccmu.edu.cn

Locations
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China, Beijing
Capital Medical University School of Stomatology Recruiting
Beijing, Beijing, China, 100050
Contact: Jingchao Hu, Ph.D    +86 13716607107    hujingchao117@hotmail.com   
Sponsors and Collaborators
Songlin Wang
Investigators
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Study Director: Songlin Wang, Ph.D Beijing Key Laboratory of Tooth Regeneration and Function Reconstruction， Capital Medical University School of Stomatology
More Information
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Responsible Party: Songlin Wang, Professor and Vice President of Capital Medical University, Capital Medical University
ClinicalTrials.gov Identifier: NCT02523651    
Other Study ID Numbers: CapitalMedicalU-1
First Posted: August 14, 2015    Key Record Dates
Last Update Posted: August 14, 2015
Last Verified: August 2015
Keywords provided by Songlin Wang, Capital Medical University:
Periodontal Diseases
Bone Regeneration
Dental Pulp Stem Cell
Additional relevant MeSH terms:
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Periodontal Diseases
Chronic Periodontitis
Mouth Diseases
Stomatognathic Diseases
 Periodontitis
Chronic Disease
Disease Attributes
Pathologic Processes