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Trial record 46 of 804 for:    Interventional Studies | mesenchymal

Gingiva Mesenchymal Stem Cells Treatment of Chronic Periodontitis

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

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 Type : Interventional
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

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

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.




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03137979


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

Responsible Party: Quanhai Li, Director of Cell Thearpy Center, the First Hospital of HebeiMU, Hebei Medical University
ClinicalTrials.gov Identifier: NCT03137979     History of Changes
Other Study ID Numbers: 17277787D-PD
First Posted: May 3, 2017    Key Record Dates
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