Clinical Trial: Periodontal Regeneration of Chronic Periodontal Disease Patients Receiving Stem Cells Injection Therapy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Summary: 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.
Sponsor: Songlin Wang

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Capital Medical University

Dates:
Date Received: June 10, 2015
Date Started: December 2014
Date Completion: December 2016
Last Updated: August 13, 2015
Last Verified: August 2015