A Phase 1/2 interventional study of DPSC injection and Placebo in Periodontal Diseases, sponsored by Songlin Wang. Status unknown at 1 site in China. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2015-08-14.
Sponsored by Songlin Wang · Phase 1/2, Interventional, and Treatment
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.
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.
855 studies on the registry are indexed under Periodontal Diseases; 189 are open to participants now.
This study's planned enrollment of 40 is below the median of 45 across 546 interventional studies indexed under Periodontal Diseases.
Browse Periodontal Diseases studies →This is the only study on the registry with Songlin Wang as lead sponsor.
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Diagnosis of periodontal disease will be based on clinical assessment of:
Exclusion Criteria:
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
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 containing 1000000 DPSCs were injected at the local periodontal defects immediately after periodontal scaling and root planing.
A 0.5ml saline preparation were injected at the local periodontal defects immediately after periodontal scaling and root planing.
Change from Baseline alveolar bone volume examined by computed tomography(CT) at 1 year
Time frame: Baseline and 1 year after intervention.
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
The record gives a start of Dec 2014, a primary completion of Dec 2015 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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