Gingiva Mesenchymal Stem Cells Treatment of Chronic Periodontitis

• ClinicalTrials.gov Identifier: NCT03137979
• Recruitment Status: Unknown
• First Posted: May 3, 2017
• Last Update Posted: May 3, 2017
• Sponsor: Hebei Medical University
• Information provided by (Responsible Party): Quanhai Li, Hebei Medical University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Periodontitis	Biological: GMSCs and collagen scaffolds; Biological: Collagen scaffolds; Procedure: Open flap debridement	Phase 1; Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: The Safety and Efficacy Evaluation of Gingiva Mesenchymal Stem Cells Transplantation in Chronic Periodontitis Patients
• Study Start Date: January 2017
• Estimated Primary Completion Date: December 2018
• Estimated Study Completion Date: December 2019

Arms and Interventions

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.
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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Probing pocket depth (PPD) [ Time Frame: Baseline and Post cell transplantation: 3, 6 months after intervention. ]
   A reduced distance in mm between the gingival margin and the bottom was measured by a manual periodontal probe.
2. Attachment level (AL) [ Time Frame: Baseline and Post cell transplantation: 3, 6 months after intervention. ]
   A reduced distance in mm from the bottom of the periodontal pocket to the dentinocemental junction was examined by a manual probe.
3. Gingival index (GI) [ Time Frame: Baseline and Post cell transplantation: 3, 6 months after intervention. ]
   A decreased degree of GI measured by a manual periodontal probe which was divided into 4 grades: 0, 1, 2 and 3.
4. Tooth mobility degree (TMD) [ Time Frame: Baseline and Post cell transplantation: 1,3, 6months after intervention ]
   A decrease of periotest value was measured by periotest to evaluate the tooth mobility changes.

Other Outcome Measures:

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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Quanhai Li, Doctor; 86-311-85917287; liquanh2@163.com

Locations

China, Hebei

the First Hospital of Hebei Medical University; Recruiting

Shijiazhuang, Hebei, China, 050030

Contact: Xianyun Wang, Doctor 86-311-85917384 wangxianyun_mbb@126.com

Sponsors and Collaborators

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: Jun Zhang, Master; The First Hospital of Hebei Medical University
• 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

More Information

• Responsible Party: Quanhai Li, Director of Cell Thearpy Center, the First Hospital of HebeiMU, Hebei Medical University
• ClinicalTrials.gov Identifier: NCT03137979
• Other Study ID Numbers: 17277787D-PD
• First Posted: May 3, 2017
• Last Update Posted: May 3, 2017
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Quanhai Li, Hebei Medical University:

Periodontitis; Gingiva mesenchymal stem cells

Additional relevant MeSH terms:

Periodontitis; Chronic Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes