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

Tracking Information

• First Submitted Date: April 24, 2017
• First Posted Date: May 3, 2017
• Last Update Posted Date: May 3, 2017
• Study Start Date: January 2017
• Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 28, 2017)

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)

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: April 28, 2017)

• 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.
• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: April 28, 2017)

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.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Periodontitis

Intervention

• Biological: GMSCs and collagen scaffolds
  Patients in this group were given GMSCs and collagen scaffolds.
• Biological: Collagen scaffolds
  Patients in this group were given collagen scaffolds.
• Procedure: Open flap debridement
  The patients in this group will only receive the treatment of open flap debridement.

Study Arms

• 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.
  Intervention: Biological: 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.
  Intervention: Biological: Collagen scaffolds
• Group C: comparator
  Patients in comparator group will only undergo an open flap debridement.
  Intervention: Procedure: Open flap debridement

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 28, 2017): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2019
• Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 35 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03137979
• Other Study ID Numbers: 17277787D-PD
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Quanhai Li, Hebei Medical University
• Original Responsible Party: Same as current
• Current Study Sponsor: Hebei Medical University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

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

• PRS Account: Hebei Medical University
• Verification Date: April 2017