Clinical trial NCT03137979: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Periodontitis
Keywords: Periodontitis
Gingiva mesenchymal stem cells
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The evaluation of alveolar bone regeneration
timeFrame: Baseline and Post cell transplantation: 1,3, 6months after intervention
Secondary outcomes:
measure: Probing pocket depth (PPD)
timeFrame: Baseline and Post cell transplantation: 3, 6 months after intervention.
measure: Attachment level (AL)
timeFrame: Baseline and Post cell transplantation: 3, 6 months after intervention.
measure: Gingival index (GI)
timeFrame: Baseline and Post cell transplantation: 3, 6 months after intervention.
measure: Tooth mobility degree (TMD)
timeFrame: Baseline and Post cell transplantation: 1,3, 6months after intervention
Other outcomes:
measure: Adverse reaction
timeFrame: Post cell transplantation: 1, 3, 6 months
Locations:
city: Shijiazhuang
country: China
facility: the First Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: Hebei Medical University
name: Baoyong Yan, Doctor
role: STUDY_CHAIR
affiliation: The First Hospital of Hebei Medical University
name: Guangshun Liu, Master
role: STUDY_DIRECTOR
affiliation: The First Hospital of Hebei Medical University
name: Quanhai Li, Doctor
role: STUDY_DIRECTOR
affiliation: The First Hospital of Hebei Medical University
name: Xianyun Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Jinhong Zhang, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: the First Hospital of Hebei Medical UniversityT
name: Yao Wang, Bachelor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Jun Zhang, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Xiangwei Ren, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Qianfeng Liu, Bachelor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Yongbin Di, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Boyu Liu, Bachelor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Fan Zhang, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: