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

Phase 1

• Conditions: Periodontal Diseases
• Interventions: Genetic: DPSC injection; Other: Placebo

• Registration Number: NCT02523651
• Lead Sponsor: Songlin Wang

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 Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-06-10
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-13
• Last Update Submitted: 2015-08-13
• Study First Posted: 2015-08-14
• Last Update Posted: 2015-08-14
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DPSC injection	DPSC injection	20 patients will receive DPSC injection（1000000 cells/ 0.5ml） at the local periodontal defects immediately after periodontal scaling and root planing.
Placebo control	Placebo	20 patients will receive saline injection at the local periodontal defects immediately after periodontal scaling and root planing.

Primary Outcome Measures

Name	Time	Method
Change from Baseline alveolar bone volume examined by computed tomography(CT) at 1 year	Baseline and 1 year after intervention.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Capital Medical University School of Stomatology; 🇨🇳 Beijing, Beijing, China