## Protocol Section
### Identification Module
**NCT ID:** NCT03137979

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 17277787D-PD
#### Organization
**Class:** OTHER
**Full Name:** Hebei Medical University
### Status Module
#### Completion Date
**Date:** 2019-12

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2017-05-03

**Type:** ACTUAL

**Last Update Submit Date:** 2017-04-28

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2018-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2017-01

**Status Verified Date:** 2017-04

#### Study First Post Date
**Date:** 2017-05-03
**Type:** ACTUAL
**Study First Submit Date:** 2017-04-24
**Study First Submit QC Date:** 2017-04-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hebei Medical University

#### Responsible Party

**Investigator Affiliation:** Hebei Medical University

**Investigator Full Name:** Quanhai Li

**Investigator Title:** Director of Cell Thearpy Center, the First Hospital of HebeiMU

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Periodontitis

**Keywords:**

- Periodontitis

- Gingiva mesenchymal stem cells

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients in group A will receive GMSCs seeded into collagen scaffolds at the local periodontal defects immediately after open flap debridement.

**Intervention Names:**

- Biological: GMSCs and collagen scaffolds

**Label:** Group A: GMSCs and collagen scaffolds

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Biological: Collagen scaffolds

**Label:** Group B: collagen scaffolds

**Type:** EXPERIMENTAL

#### Arm Group 3

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

**Intervention Names:**

- Procedure: Open flap debridement

**Label:** Group C: comparator

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group A: GMSCs and collagen scaffolds

**Description:** Patients in this group were given GMSCs and collagen scaffolds.

**Name:** GMSCs and collagen scaffolds

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Group B: collagen scaffolds

**Description:** Patients in this group were given collagen scaffolds.

**Name:** Collagen scaffolds

**Type:** BIOLOGICAL

#### Intervention 3

**Arm Group Labels:**

- Group C: comparator

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

**Name:** Open flap debridement

**Type:** PROCEDURE

### Outcomes Module

#### Other Outcomes

**Description:** Adverse reaction include temperature changes, allergy, nausea and so on 6 months after intervention.

**Measure:** Adverse reaction

**Time Frame:** Post cell transplantation: 1, 3, 6 months

#### Primary Outcomes

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

**Measure:** The evaluation of alveolar bone regeneration

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

#### Secondary Outcomes

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

**Measure:** Probing pocket depth (PPD)

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

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

**Measure:** Attachment level (AL)

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

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

**Measure:** Gingival index (GI)

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

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

**Measure:** Tooth mobility degree (TMD)

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

### Eligibility Module

**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.

**Maximum Age:** 60 Years

**Minimum Age:** 35 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** liquanh2@163.com

**Name:** Quanhai Li, Doctor

**Phone:** 86-311-85917287

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shijiazhuang

**Contacts:**

***Contact 1:***

- **Email:** wangxianyun_mbb@126.com

- **Name:** Xianyun Wang, Doctor

- **Phone:** 86-311-85917384

- **Role:** CONTACT

**Country:** China

**Facility:** the First Hospital of Hebei Medical University

**State:** Hebei

**Status:** RECRUITING

**Zip:** 050030

#### Overall Officials

**Official 1:**

**Affiliation:** Hebei Medical University

**Name:** Baoyong Yan, Doctor

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** The First Hospital of Hebei Medical University

**Name:** Guangshun Liu, Master

**Role:** STUDY_DIRECTOR

**Official 3:**

**Affiliation:** The First Hospital of Hebei Medical University

**Name:** Quanhai Li, Doctor

**Role:** STUDY_DIRECTOR

**Official 4:**

**Affiliation:** The First Hospital of Hebei Medical University

**Name:** Xianyun Wang, Doctor

**Role:** PRINCIPAL_INVESTIGATOR

**Official 5:**

**Affiliation:** The First Hospital of Hebei Medical University

**Name:** Jinhong Zhang, Master

**Role:** PRINCIPAL_INVESTIGATOR

**Official 6:**

**Affiliation:** the First Hospital of Hebei Medical UniversityT

**Name:** Yao Wang, Bachelor

**Role:** PRINCIPAL_INVESTIGATOR

**Official 7:**

**Affiliation:** The First Hospital of Hebei Medical University

**Name:** Jun Zhang, Master

**Role:** PRINCIPAL_INVESTIGATOR

**Official 8:**

**Affiliation:** The First Hospital of Hebei Medical University

**Name:** Xiangwei Ren, Master

**Role:** PRINCIPAL_INVESTIGATOR

**Official 9:**

**Affiliation:** The First Hospital of Hebei Medical University

**Name:** Qianfeng Liu, Bachelor

**Role:** PRINCIPAL_INVESTIGATOR

**Official 10:**

**Affiliation:** The First Hospital of Hebei Medical University

**Name:** Yongbin Di, Master

**Role:** PRINCIPAL_INVESTIGATOR

**Official 11:**

**Affiliation:** The First Hospital of Hebei Medical University

**Name:** Boyu Liu, Bachelor

**Role:** PRINCIPAL_INVESTIGATOR

**Official 12:**

**Affiliation:** The First Hospital of Hebei Medical University

**Name:** Fan Zhang, Bachelor

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010510

- Term: Periodontal Diseases

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13427

- Name: Periodontitis

- Relevance: HIGH

- As Found: Periodontitis

- ID: M28044

- Name: Chronic Periodontitis

- Relevance: HIGH

- As Found: Chronic Periodontitis

- ID: M13419

- Name: Periodontal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010518

- Term: Periodontitis

- ID: D000055113

- Term: Chronic Periodontitis

### Misc Info Module

- Version Holder: 2024-05-24
