Gingiva Mesenchymal Stem Cells Treatment of Chronic Periodontitis

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

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

Study Overview

• Status: Unknown
• Conditions: Periodontitis
• Intervention / Treatment: Biological: GMSCs and collagen scaffolds; Biological: Collagen scaffolds; Procedure: Open flap debridement

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Quanhai Li, Doctor; Phone Number: 86-311-85917287; Email: liquanh2@163.com

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050030
      • Recruiting
      • The First Hospital of Hebei Medical University
      • Contact: Xianyun Wang, Doctor; Phone Number: 86-311-85917384; Email: wangxianyun_mbb@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: GMSCs and collagen scaffolds; Patients in group A will receive GMSCs seeded into collagen scaffolds at the local periodontal defects immediately after open flap debridement.	Biological: GMSCs and collagen scaffolds; Patients in this group were given GMSCs and collagen scaffolds.
Experimental: Group B: collagen scaffolds; Patients in group B will receive collagen scaffolds implantation at the local periodontal defects immediately after open flap debridement.	Biological: Collagen scaffolds; Patients in this group were given collagen scaffolds.
Other: Group C: comparator; Patients in comparator group will only undergo an open flap debridement.	Procedure: Open flap debridement; The patients in this group will only receive the treatment of open flap debridement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The evaluation of alveolar bone regeneration	A increase in the height of alveolar bone in mm examined by computed tomography (CT)	Baseline and Post cell transplantation: 1,3, 6months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing pocket depth (PPD)	A reduced distance in mm between the gingival margin and the bottom was measured by a manual periodontal probe.	Baseline and Post cell transplantation: 3, 6 months after intervention.
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.	Baseline and Post cell transplantation: 3, 6 months after intervention.
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.	Baseline and Post cell transplantation: 3, 6 months after intervention.
Tooth mobility degree (TMD)	A decrease of periotest value was measured by periotest to evaluate the tooth mobility changes.	Baseline and Post cell transplantation: 1,3, 6months after intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse reaction	Adverse reaction include temperature changes, allergy, nausea and so on 6 months after intervention.	Post cell transplantation: 1, 3, 6 months

Collaborators and Investigators

• Sponsor: Hebei Medical University
• Investigators: Study Chair: Baoyong Yan, Doctor, Hebei Medical University; Study Director: Guangshun Liu, Master, The First Hospital of Hebei Medical University; Study Director: Quanhai Li, Doctor, The First Hospital of Hebei Medical University; Principal Investigator: Xianyun Wang, Doctor, The First Hospital of Hebei Medical University; Principal Investigator: Jinhong Zhang, Master, The First Hospital of Hebei Medical University; Principal Investigator: Yao Wang, Bachelor, the First Hospital of Hebei Medical UniversityT; Principal Investigator: Xiangwei Ren, Master, The First Hospital of Hebei Medical University; Principal Investigator: Qianfeng Liu, Bachelor, The First Hospital of Hebei Medical University; Principal Investigator: Yongbin Di, Master, The First Hospital of Hebei Medical University; Principal Investigator: Boyu Liu, Bachelor, The First Hospital of Hebei Medical University; Principal Investigator: Fan Zhang, Bachelor, The First Hospital of Hebei Medical University

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: April 24, 2017
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): May 3, 2017
• Last Update Submitted That Met QC Criteria: April 28, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Periodontitis; Gingiva mesenchymal stem cells
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: 17277787D-PD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No