Gingiva Mesenchymal Stem Cells Treatment of Chronic Periodontitis

April 28, 2017 updated by: Quanhai Li, Hebei Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Baseline and Post cell transplantation: 1,3, 6months after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and Post cell transplantation: 3, 6 months after intervention.
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.
Baseline and Post cell transplantation: 3, 6 months after intervention.
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.
Baseline and Post cell transplantation: 3, 6 months after intervention.
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.
Baseline and Post cell transplantation: 1,3, 6months after intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Post cell transplantation: 1, 3, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hebei Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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