Back to results

Gingiva Mesenchymal Stem Cells Treatment of Chronic Periodontitis

Primary Purpose

Periodontitis

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

GMSCs and collagen scaffolds

Collagen scaffolds

Open flap debridement

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Periodontitis, Gingiva mesenchymal stem cells

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with adult periodontitis .
The age is from 35 to 60 years old.
The bleeding and coagulation function is normal.
The liver function is normal.
Patients who are suitable for routine treatment of periodontal curettage and other early treatments.
Pathological lesion is stable after the routine treatments.
Patients with the probing depth ≥6 mm and attachment loss level≥ 3 mm.
X ray plates show no significant root furcation lesion appears in the diseased teeth and the infrabony pocket is not less than 4mm deep.
Patients with good oral hygiene and/or in whom the plaque control is maintained excellently under the instruction of oral hygiene.
Patients who show good compliance.
Patients with tooth mobility of degreeⅡor less and the width of attached gingiva is considered appropriate for the existing Guided Tissue Regeneration (GTR) .
Patients who have understand the purposes of this clinical trial and can make an independent decision to comply with trial requirements.

Exclusion Criteria:

Patients with disease of the kidney, liver, blood and/or circulatory system.
Patients with diabetes (the fasting plasma glucose level≥7.0mmol/l).
Patients who are receiving treatment of hypertension and/or epilepsy.
Patients with malignant tumour or the history of this.
Patients with the genetic background of the periodontitis.
Patients with bone metabolic diseases.
Patients in need of administration of adrenal cortical steroid within 4 weeks.
Patients with alcoholics.
Patients who smoke more than 10 pieces of cigarettes.
Patients who suffer from drug induced gingival hyperplasia.
Patients with acute symptom of periodontitis.
The bone destruction is larger than 2/3 of the root length or the mobility tooth is investigated of more than degree Ⅱ.
Patients who are either pregnant, possibly pregnant or breast-feeding, or who hope to become pregnant during the period of the trial.
Patients who are participating in in other research team of clinical trial.
Patients with mental or consciousness disorder.
Patients with a previous history of hypersensitivity to any biological active drugs.
Patients who have undergo periodontal treatment within six months.

Sites / Locations

the First Hospital of Hebei Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Arm Label

Group A: GMSCs and collagen scaffolds

Group B: collagen scaffolds

Group C: comparator

Arm Description

Patients in group A will receive GMSCs seeded into collagen scaffolds at the local periodontal defects immediately after open flap debridement.

Patients in group B will receive collagen scaffolds implantation at the local periodontal defects immediately after open flap debridement.

Patients in comparator group will only undergo an open flap debridement.

Outcomes

Primary Outcome Measures

The evaluation of alveolar bone regeneration

A increase in the height of alveolar bone in mm examined by computed tomography (CT)

Secondary Outcome Measures

Probing pocket depth (PPD)

A reduced distance in mm between the gingival margin and the bottom was measured by a manual periodontal probe.

Attachment level (AL)

A reduced distance in mm from the bottom of the periodontal pocket to the dentinocemental junction was examined by a manual probe.

Gingival index (GI)

A decreased degree of GI measured by a manual periodontal probe which was divided into 4 grades: 0, 1, 2 and 3.

Tooth mobility degree (TMD)

A decrease of periotest value was measured by periotest to evaluate the tooth mobility changes.

Full Information

NCT ID

NCT03137979

First Posted

April 24, 2017

Last Updated

April 28, 2017

Sponsor

Hebei Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03137979

Brief Title

Gingiva Mesenchymal Stem Cells Treatment of Chronic Periodontitis

Official Title

The Safety and Efficacy Evaluation of Gingiva Mesenchymal Stem Cells Transplantation in Chronic Periodontitis Patients

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 2017 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hebei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is to evaluate the safety and efficacy of Gingiva Mesenchymal Stem Cell Therapy for Chronic Adult Periodontitis.

Detailed Description

Periodontitis featured by the progressive destruction loss of support tissues around the teeth has become a prevalent disease affecting the life quality of the adults. Although conventional periodontal treatment including open flap debridement and drug support therapy display reduced pocket depth and inflammation, the functional regeneration of the lost tissue and the repair of alveolar bone are insufficient. Gingiva mesenchymal stem cells (GMSCs) are multipotent cells possess the capacity of multilineage differentiation and have become an attractive optional treatment method for the regeneration of periodontal tissues and function. Therefore, GMSCs will be selected as seed cells to treat periodontitis. This study will recruit 30 patients which will be divided into three groups. 10 patients in group A will receive GMSCs seeded into collagen scaffolds at the local periodontal defects immediately after open flap debridement. 10 patients in group B will only receive collagen scaffolds devoid of GMSCs after open flap debridement. 10 patients in group C will only undergo an open flap debridement. This study will test the safety and efficacy of GMSCs implantation in chronic adult periodontitis through alveolous bone reproduction and other clinical parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontitis

Keywords

Periodontitis, Gingiva mesenchymal stem cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A: GMSCs and collagen scaffolds

Arm Type

Experimental

Arm Description

Patients in group A will receive GMSCs seeded into collagen scaffolds at the local periodontal defects immediately after open flap debridement.

Arm Title

Group B: collagen scaffolds

Arm Type

Experimental

Arm Description

Patients in group B will receive collagen scaffolds implantation at the local periodontal defects immediately after open flap debridement.

Arm Title

Group C: comparator

Arm Type

Other

Arm Description

Patients in comparator group will only undergo an open flap debridement.

Intervention Type

Biological

Intervention Name(s)

GMSCs and collagen scaffolds

Intervention Description

Patients in this group were given GMSCs and collagen scaffolds.

Intervention Type

Biological

Intervention Name(s)

Collagen scaffolds

Intervention Description

Patients in this group were given collagen scaffolds.

Intervention Type

Procedure

Intervention Name(s)

Open flap debridement

Intervention Description

The patients in this group will only receive the treatment of open flap debridement.

Primary Outcome Measure Information:

Title

The evaluation of alveolar bone regeneration

Description

A increase in the height of alveolar bone in mm examined by computed tomography (CT)

Time Frame

Baseline and Post cell transplantation: 1,3, 6months after intervention

Secondary Outcome Measure Information:

Title

Probing pocket depth (PPD)

Description

A reduced distance in mm between the gingival margin and the bottom was measured by a manual periodontal probe.

Time Frame

Baseline and Post cell transplantation: 3, 6 months after intervention.

Title

Attachment level (AL)

Description

A reduced distance in mm from the bottom of the periodontal pocket to the dentinocemental junction was examined by a manual probe.

Time Frame

Baseline and Post cell transplantation: 3, 6 months after intervention.

Title

Gingival index (GI)

Description

A decreased degree of GI measured by a manual periodontal probe which was divided into 4 grades: 0, 1, 2 and 3.

Time Frame

Baseline and Post cell transplantation: 3, 6 months after intervention.

Title

Tooth mobility degree (TMD)

Description

A decrease of periotest value was measured by periotest to evaluate the tooth mobility changes.

Time Frame

Baseline and Post cell transplantation: 1,3, 6months after intervention

Other Pre-specified Outcome Measures:

Title

Adverse reaction

Description

Adverse reaction include temperature changes, allergy, nausea and so on 6 months after intervention.

Time Frame

Post cell transplantation: 1, 3, 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with adult periodontitis . The age is from 35 to 60 years old. The bleeding and coagulation function is normal. The liver function is normal. Patients who are suitable for routine treatment of periodontal curettage and other early treatments. Pathological lesion is stable after the routine treatments. Patients with the probing depth ≥6 mm and attachment loss level≥ 3 mm. X ray plates show no significant root furcation lesion appears in the diseased teeth and the infrabony pocket is not less than 4mm deep. Patients with good oral hygiene and/or in whom the plaque control is maintained excellently under the instruction of oral hygiene. Patients who show good compliance. Patients with tooth mobility of degreeⅡor less and the width of attached gingiva is considered appropriate for the existing Guided Tissue Regeneration (GTR) . Patients who have understand the purposes of this clinical trial and can make an independent decision to comply with trial requirements. Exclusion Criteria: Patients with disease of the kidney, liver, blood and/or circulatory system. Patients with diabetes (the fasting plasma glucose level≥7.0mmol/l). Patients who are receiving treatment of hypertension and/or epilepsy. Patients with malignant tumour or the history of this. Patients with the genetic background of the periodontitis. Patients with bone metabolic diseases. Patients in need of administration of adrenal cortical steroid within 4 weeks. Patients with alcoholics. Patients who smoke more than 10 pieces of cigarettes. Patients who suffer from drug induced gingival hyperplasia. Patients with acute symptom of periodontitis. The bone destruction is larger than 2/3 of the root length or the mobility tooth is investigated of more than degree Ⅱ. Patients who are either pregnant, possibly pregnant or breast-feeding, or who hope to become pregnant during the period of the trial. Patients who are participating in in other research team of clinical trial. Patients with mental or consciousness disorder. Patients with a previous history of hypersensitivity to any biological active drugs. Patients who have undergo periodontal treatment within six months.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Quanhai Li, Doctor

Phone

86-311-85917287

liquanh2@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Baoyong Yan, Doctor

Organizational Affiliation

Hebei Medical University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Guangshun Liu, Master

Organizational Affiliation

The First Hospital of Hebei Medical University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Quanhai Li, Doctor

Organizational Affiliation

The First Hospital of Hebei Medical University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Xianyun Wang, Doctor

Organizational Affiliation

The First Hospital of Hebei Medical University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jinhong Zhang, Master

Organizational Affiliation

The First Hospital of Hebei Medical University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yao Wang, Bachelor

Organizational Affiliation

the First Hospital of Hebei Medical UniversityT

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jun Zhang, Master

Organizational Affiliation

The First Hospital of Hebei Medical University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Xiangwei Ren, Master

Organizational Affiliation

The First Hospital of Hebei Medical University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Qianfeng Liu, Bachelor

Organizational Affiliation

The First Hospital of Hebei Medical University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yongbin Di, Master

Organizational Affiliation

The First Hospital of Hebei Medical University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Boyu Liu, Bachelor

Organizational Affiliation

The First Hospital of Hebei Medical University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Fan Zhang, Bachelor

Organizational Affiliation

The First Hospital of Hebei Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

the First Hospital of Hebei Medical University

City

Shijiazhuang

State/Province

Hebei

ZIP/Postal Code

050030

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xianyun Wang, Doctor

Phone

86-311-85917384

wangxianyun_mbb@126.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Gingiva Mesenchymal Stem Cells Treatment of Chronic Periodontitis

We'll reach out to this number within 24 hrs