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

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

Tracking Information

• First Submitted Date: June 10, 2015
• First Posted Date: August 14, 2015
• Last Update Posted Date: August 14, 2015
• Study Start Date: December 2014
• Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 13, 2015): Change from Baseline alveolar bone volume examined by computed tomography(CT) at 1 year [ Time Frame: Baseline and 1 year after intervention. ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 13, 2015)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Periodontal Diseases

Intervention

• 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.
• Other: Placebo
  A 0.5ml saline preparation were injected at the local periodontal defects immediately after periodontal scaling and root planing.

Study Arms

• 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.
  Intervention: Genetic: DPSC injection
• Placebo Comparator: Placebo control
  20 patients will receive saline injection at the local periodontal defects immediately after periodontal scaling and root planing.
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 13, 2015): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2016
• Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02523651
• Other Study ID Numbers: CapitalMedicalU-1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Songlin Wang, Capital Medical University
• Original Responsible Party: Same as current
• Current Study Sponsor: Songlin Wang
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Capital Medical University
• Verification Date: August 2015