Gingiva Mesenchymal Stem Cells Treatment of Chronic Periodontitis

NCT03137979 | Unknown Phase 1 DMC

• 1 other identifier: 17277787D-PD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periodontitis

Keywords

Periodontitis; Gingiva mesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

• The evaluation of alveolar bone regeneration

  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 Outcomes (4)

• Probing pocket depth (PPD)

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

• Attachment level (AL)

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

• Gingival index (GI)

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

• Tooth mobility degree (TMD)

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

Other Outcomes (1)

• Adverse reaction

  Post cell transplantation: 1, 3, 6 months

Study Arms (3)

Group A: GMSCs and collagen scaffolds

EXPERIMENTAL

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

Group B: collagen scaffolds

EXPERIMENTAL

Patients in group B will receive collagen scaffolds implantation at the local periodontal defects immediately after open flap debridement.

Biological: Collagen scaffolds

Group C: comparator

OTHER

Patients in comparator group will only undergo an open flap debridement.

Procedure: Open flap debridement

Interventions

GMSCs and collagen scaffolds BIOLOGICAL

Patients in this group were given GMSCs and collagen scaffolds.

Group A: GMSCs and collagen scaffolds

Collagen scaffolds BIOLOGICAL

Patients in this group were given collagen scaffolds.

Group B: collagen scaffolds

Open flap debridement PROCEDURE

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

Group C: comparator

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hebei Medical University: lead

Study Sites (1)

the First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050030, China

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Baoyong Yan, Doctor

  Hebei Medical University

  STUDY CHAIR

• Guangshun Liu, Master

  The First Hospital of Hebei Medical University

  STUDY DIRECTOR

• Quanhai Li, Doctor

  The First Hospital of Hebei Medical University

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Quanhai Li, Doctor

CONTACT

86-311-85917287; liquanh2@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cell Thearpy Center, the First Hospital of HebeiMU

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: May 3, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: May 3, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)