AzTrials
AzTrials

PeriodontitisPhase 1/2NCT03137979

Gingiva Mesenchymal Stem Cells Treatment of Chronic Periodontitis

A Phase 1/2 study testing GMSCs and collagen scaffolds, Collagen scaffolds and Open flap debridement in people with Periodontitis, run by Hebei Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 35 to 60 years
Conditions the study is for
Periodontitis
What is being tested?
GMSCs and collagen scaffolds, Collagen scaffolds and Open flap debridement
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
Jan 2017to Dec 2019
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients with adult periodontitis .
  • The age is from 35 to 60 years old.
  • The bleeding and coagulation function is normal.
  • The liver function is normal.
  • Patients who are suitable for routine treatment of periodontal curettage and other early treatments.
  • Pathological lesion is stable after the routine treatments.
Show all 12Show fewer
  • Patients with the probing depth ≥6 mm and attachment loss level≥ 3 mm.
  • X ray plates show no significant root furcation lesion appears in the diseased teeth and the infrabony pocket is not less than 4mm deep.
  • Patients with good oral hygiene and/or in whom the plaque control is maintained excellently under the instruction of oral hygiene.
  • Patients who show good compliance.
  • Patients with tooth mobility of degreeⅡor less and the width of attached gingiva is considered appropriate for the existing Guided Tissue Regeneration (GTR) .
  • Patients who have understand the purposes of this clinical trial and can make an independent decision to comply with trial requirements.

Who cannot join

  • Patients with disease of the kidney, liver, blood and/or circulatory system.
  • Patients with diabetes (the fasting plasma glucose level≥7.0mmol/l).
  • Patients who are receiving treatment of hypertension and/or epilepsy.
  • Patients with malignant tumour or the history of this.
  • Patients with the genetic background of the periodontitis.
  • Patients with bone metabolic diseases.
Show all 17Show fewer
  • Patients in need of administration of adrenal cortical steroid within 4 weeks.
  • Patients with alcoholics.
  • Patients who smoke more than 10 pieces of cigarettes.
  • Patients who suffer from drug induced gingival hyperplasia.
  • Patients with acute symptom of periodontitis.
  • The bone destruction is larger than 2/3 of the root length or the mobility tooth is investigated of more than degree Ⅱ.
  • Patients who are either pregnant, possibly pregnant or breast-feeding, or who hope to become pregnant during the period of the trial.
  • Patients who are participating in in other research team of clinical trial.
  • Patients with mental or consciousness disorder.
  • Patients with a previous history of hypersensitivity to any biological active drugs.
  • Patients who have undergo periodontal treatment within six months.

Trial locations and contacts

1 site in 1 country.

Quanhai Li, Doctor contact

86-311-85917287

liquanh2@163.com

China1 site, 1 recruiting

  • the First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050030

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

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions
Periodontitis
Being tested
GMSCs and collagen scaffolds, Collagen scaffolds, Open flap debridement
Keywords
Periodontitis, Gingiva mesenchymal stem cells
Medical subject headings
Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GMSCs and collagen scaffoldsBiological

    Patients in this group were given GMSCs and collagen scaffolds.

  • Collagen scaffoldsBiological

    Patients in this group were given collagen scaffolds.

  • Open flap debridementProcedure or surgery

    The patients in this group will only receive the treatment of open flap debridement.

Study groups in NCT03137979
Study groupRoleWhat they receive
Group A: GMSCs and collagen scaffoldsExperimentalPatients in group A will receive GMSCs seeded into collagen scaffolds at the local periodontal defects immediately after open flap debridement.
Receives: Biological: GMSCs and collagen scaffolds
Group B: collagen scaffoldsExperimentalPatients in group B will receive collagen scaffolds implantation at the local periodontal defects immediately after open flap debridement.
Receives: Biological: Collagen scaffolds
Group C: comparatorOtherPatients in comparator group will only undergo an open flap debridement.
Receives: Procedure: Open flap debridement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The evaluation of alveolar bone regeneration

    A increase in the height of alveolar bone in mm examined by computed tomography (CT)

    Measured: Baseline and Post cell transplantation: 1,3, 6months after intervention

Secondary outcomes (4)

  1. Probing pocket depth (PPD)

    A reduced distance in mm between the gingival margin and the bottom was measured by a manual periodontal probe.

    Measured: Baseline and Post cell transplantation: 3, 6 months after intervention.

  2. Attachment level (AL)

    A reduced distance in mm from the bottom of the periodontal pocket to the dentinocemental junction was examined by a manual probe.

    Measured: Baseline and Post cell transplantation: 3, 6 months after intervention.

  3. Gingival index (GI)

    A decreased degree of GI measured by a manual periodontal probe which was divided into 4 grades: 0, 1, 2 and 3.

    Measured: Baseline and Post cell transplantation: 3, 6 months after intervention.

  4. Tooth mobility degree (TMD)

    A decrease of periotest value was measured by periotest to evaluate the tooth mobility changes.

    Measured: Baseline and Post cell transplantation: 1,3, 6months after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2017
  2. Study startJan 2017
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03137979
Sponsor's protocol ID
17277787D-PD
Status last verified
Apr 2017
First submitted
24 Apr 2017
Last updated
3 May 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GMSCs and collagen scaffolds, Collagen scaffolds and Open flap debridement in people with Periodontitis, run by Hebei Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Quanhai Li, Doctor (86-311-85917287, liquanh2@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The evaluation of alveolar bone regeneration (time frame: Baseline and Post cell transplantation: 1,3, 6months after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03137979.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in