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

Periodontal Diseases Clinical Trial

Official title:

Study of Local Periodontal Regeneration of Chronic Periodontal Disease Patients Receiving Allogeneic Human Dental Pulp Stem Cells Injection Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02523651
• Other study ID #: CapitalMedicalU-1
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: June 10, 2015
• Last updated: August 13, 2015
• Start date: December 2014
• Est. completion date: December 2016

Study information

• Verified date: August 2015
• Source: Capital Medical University
• Contact: Songlin Wang, Ph.D
• Phone: +86 13601324511
• Email: slwang[@]ccmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Gingival Diseases
• 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.

Locations

Country	Name	City	State
China	Capital Medical University School of Stomatology	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Songlin Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline alveolar bone volume examined by computed tomography(CT) at 1 year		Baseline and 1 year after intervention.	Yes
Secondary	Quigley-Hein plaque index (QHI)		Baseline	No
Secondary	Change from Baseline Bleeding on probing (BoP) at 1 year		Baseline and 1 year after intervention.	Yes
Secondary	Change from Baseline Probing depth (PD) at 1 year		Baseline and 1 year after intervention.	Yes
Secondary	Change from Baseline Clinical attachment level (CAL) at 1 year		Baseline and 1 year after intervention	Yes