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Human Dental Pulp Mesenchymal Stem Cells for the Treatment of Chronic Periodontitis Patients

Primary Purpose

Periodontitis

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Human Dental Fulp Stem Cells
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Human Dental Pulp Stem Cell

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1)18 to 65 years old (including threshold), unlimited gender; 2)Radiological examination of the periodontal defect site shows angular bone defect; 3)The probing depth (PD) at the periodontal defect site is 4 to 8 mm at baseline; 4)Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures; 5)Voluntarily participate in the clinical study, understand and sign the informed consent; Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Participants with severe periodontal diseases (alveolar bone resorption exceeds two-thirds of the tooth root length) which affect the investigator's judgment; The grade of studied tooth looseness ≥ grade 3 at baseline (only buccolingual movement is defined as grade 1; buccolingual and mesiodistal movement is grade 2; vertical loosening is grade 3); The studied tooth with occlusal trauma which affect the investigator's judgment; Participants with surgical treatment of previous periodontal defect sites and adjacent periodontal tissues; Participants with non-steroid anti-inflammatory drug, steroid hormone therapy, and/or other hormone (except topical hormones) treatment within past 3 months of the screening visit, and/or previous use of bisphosphonates; Participants with severe systemic infection within past 3 months of the screening visit, or antibiotics treatment within past 72h of the screening visit; Participants with uncontrolled hypertension within 1 month before screening (defined as sitting systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg after receiving the optimal antihypertensive therapy); Participants with severe or uncontrolled diseases in any system (cardiac, hepatic, renal, respiratory, hematologic, endocrine, nervous, or psychiatric); Participants are known to be allergic to any materials that may be used during surgery (allergy-prone constitution or history of allergy to blood products); Any of the following abnormalities in clinical laboratory tests at screening: ALT > 3 ULN, total bilirubin > 1.5 ULN, serum creatinine > 1.5 ULN, international normalized ratio (INR) ≥ 1.5 ULN or activated partial thromboplastin time (APTT) ≥ 1.5 ULN (except for patients receiving anticoagulation therapy), Hb < 80 g/L, or PLT < 75.0×109/L; Positive result for any of the following tests at screening: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (TP-Ab); Females who are pregnant or breastfeeding; Participants and their partners who plan to conceive or do not agree to use the effective non-pharmacological method of contraceptive during the trial from screening visit to 6 months after the end of the trial; Participants participated in other clinical studies within past 3 months of the screening visit; Participants with a history of smoking addiction within past 12 months of the screening visit (the number of cigarettes smoked per day ≥ 10); Other circumstances deemed inappropriate by the investigator.

Sites / Locations

  • Peking University Third Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

single-dose group

two-dose group (low-dose)

two-dose group (high-dose)

Arm Description

Human Dental Fulp Stem Cells Injection: 1X 10^7 cells/periodontaldefect site.

Human Dental Pulp Stem Cells Injection: 1X 10^6 cells/periodontaldefect site. Continuous administration twice, with an interval of 89 days between each administration.

Human Dental Pulp Stem Cells Injection: 1X 10^7 cells/periodontaldefect site. Continuous administration twice, with an interval of 89 days between each administration.

Outcomes

Primary Outcome Measures

Changes from baseline in height of the periodontal bone defect
Changes from baseline in height of the periodontal bone defect which will be examined by CBCT at D90±7 and D180±14 (primary efficacy endpoint)

Secondary Outcome Measures

Changes from baseline in respiration rate of Vital Signs
Respiratory rate, in beats per minute
Changes from baseline in heart rate of Vital Signs
Heart rate in beats per minute
Changes from baseline in blood pressure of Vital Signs
Blood pressure in mmHg, both systolic and diastolic blood pressure will be measured.
Changes from baseline in body temperature of Vital Signs
Body temperature in Celsius degree
Changes from baseline in red blood cell count of Laboratory Examination
Red blood cell count in whole blood is reported in the form of number
Changes from baseline in white blood cell count of Laboratory Examination
White blood cell count in whole blood is reported in the form of number
Changes from baseline in neutrophil count of Laboratory Examination
Neutrophil count in whole blood is reported in the form of number
Changes from baseline in lymphocyte count of Laboratory Examination
Lymphocyte count in whole blood is reported in the form of number
Changes from baseline in platelet count of Laboratory Examination
Platelet count in whole blood is reported in the form of number
Changes from baseline in hemoglobin of Laboratory Examination
Changes of hemoglobin concentration(g/dL)in whole blood will be recorded.
Changes from baseline in PT of Laboratory Examination
Prothrombin time (PT) is a screening test for exogenous coagulation factors
Changes from baseline in INR of Laboratory Examination
International standardized ratio (INR) is calculated from prothrombin time and international sensitivity index (ISI) of the reagent.
Changes from baseline in APTT of Laboratory Examination
Activated partial thromboplastin time (APTT) is a screening test for endogenous coagulation factors
Changes from baseline in total bilirubin of Laboratory Examination
Changes of total bilirubin concentration (μmol/L) in serum will be recorded
Changes from baseline in direct bilirubin of Laboratory Examination
Changes of direct bilirubin concentration (μmol/L) in serum will be recorded
Changes from baseline in ALT of Laboratory Examination
Changes of ALT concentration (U/L) in serum will be recorded
Changes from baseline in AST of Laboratory Examination
Changes of AST concentration (U/L) in serum will be recorded
Changes from baseline in total protein of Laboratory Examination
Changes of total protein concentration (g/L) in serum will be recorded
Changes from baseline in albumin of Laboratory Examination
Changes of albumin concentration (g/L) in serum will be recorded
Changes from baseline in total bile acid of Laboratory Examination
Changes of total bile acid concentration (μmol/L) in serum will be recorded
Changes from baseline in urea of Laboratory Examination
Changes of urea concentration (mmol/L) in serum will be recorded
Changes from baseline in creatinine of Laboratory Examination
Changes of creatinine concentration (μmol/L) in serum will be recorded
Changes from baseline in uric acid of Laboratory Examination
Changes of uric acid concentration (μmol/L) in serum will be recorded
Changes from baseline in glucose of Laboratory Examination
Changes of glucose concentration (mmol/L) in serum will be recorded
Changes from baseline in potassium of Laboratory Examination
Changes of potassium concentration (mmol/L) in serum will be recorded
Changes from baseline in sodium of Laboratory Examination
Changes of sodium concentration (mmol/L) in serum will be recorded
Changes from baseline in chlorine of Laboratory Examination
Changes of chlorine concentration (mmol/L) in serum will be recorded
Changes from baseline in Detection of infectious diseases of Laboratory Examination
It refers to infectious diseases screening
Changes from baseline in IgA of Laboratory Examination
Changes of IgA concentration (g/L)in serum will be recorded
Changes from baseline in IgG of Laboratory Examination
Changes of IgG concentration (g/L)in serum will be recorded
Changes from baseline in IgM of Laboratory Examination
Changes of IgM concentration (g/L)in serum will be recorded
Changes from baseline in total IgE of Laboratory Examination
Changes of total IgE concentration (g/L)in serum will be recorded
Changes from baseline in Pregnancy test of Laboratory Examination
Pregnancy test will be tested in female subjects
Changes from baseline in urine specific gravity of Laboratory Examination
Changes of urine specific gravity will be recorded
Changes from baseline in urine pH of Laboratory Examination
Changes of urine pH value will be recorded
Changes from baseline in urine glucose of Laboratory Examination
Changes of urine glucose will be examined by qualitative test (positive or negative)
Changes from baseline in urine protein of Laboratory Examination
Changes of urine protein will be examined by qualitative test (positive or negative)
Changes from baseline in urine ketone body of Laboratory Examination
Changes of urine ketone body will be examined by qualitative test (positive or negative)
Changes from baseline in urine white blood cell of Laboratory Examination
Changes of white blood cell in urine will be examined by qualitative test (positive or negative)
Changes from baseline in urine bilirubin of Laboratory Examination
Changes of urine bilirubin will be examined by qualitative test (positive or negative)
Changes from baseline in urine occult blood of Laboratory Examination
Changes of urine occult blood will be examined by qualitative test (positive or negative)
Changes from baseline in ECG PR interval
The cardiac rhythm is showed in 12 Leads Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded.
Changes from baseline in ECG QRS interval
The cardiac rhythm is showed in 12 Leads Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded.
Changes from baseline in ECG RR interval
The cardiac rhythm is showed in 12 Leads Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded.
Changes from baseline in ECG QT interval
The cardiac rhythm is showed in 12 Leads Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded.
Incidence of Treatment-Emergent Adverse Event
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events during the study period, and the severity of adverse events is determined according to the NCI CTCAE version 5.0
Change from baseline in Clinical Attachment Level (AL)
Clinical Attachment Level (AL) may be assessed to the nearest millimeter by means of a graduated probe and expressed as the distance in millimeters from the CEJ to the bottom of the probeable gingival/periodontal pocket
Change from baseline in Tooth Mobility (TM)
The continuous loss of the supporting tissues during periodontal disease progression may result in increased tooth mobility, which is divided into 3 degree: I°, II°, and III°. Changes from baseline in tooth mobility will be recorded
Change from baseline in Probing Depth (PD)
The probing depth is the distance from the gingival margin to the bottom of the gingival sulcus/pocket, is measured to the nearest millimeter by means of periodontal probe
Change from baseline in Gingival recession (GR)
Exposure of the tooth through apical migration of the gingiva is called gingival recession. Recorded as the distance in millimeters from the CEJ to the gingival margin
Change from baseline in Probing bleeding on probing (BOP)
A periodontal probe is inserted to the "bottom" of the gingival/periodontal pocket applying light force and is moved gently along the tooth (root) surface. If bleeding is provoked by this examination, the site examined is considered bleeding on probing-positive and, hence, inflamed. Probing Bleeding Index is divided into 5 grades: 0, 1, 2, 3 and 4.

Full Information

First Posted
May 17, 2023
Last Updated
June 20, 2023
Sponsor
Peking University Third Hospital
Collaborators
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05924373
Brief Title
Human Dental Pulp Mesenchymal Stem Cells for the Treatment of Chronic Periodontitis Patients
Official Title
A Phase 2, Randomized, Double-blind, Parallel, Placebo-controlled Study to Evaluate Efficacy and Safety of Local Injection of Human Dental Pulp Mesenchymal Stem Cells for the Treatment of Chronic Periodontitis Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 30, 2023 (Anticipated)
Primary Completion Date
March 7, 2025 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
Collaborators
Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective:To evaluate the efficacy of different administration protocols of human dental pulp mesenchymal stem cells for the treatment of chronic periodontitis patients. The secondary objective:To evaluate the safety of different administration protocols of human dental pulp mesenchymal stem cells for the treatment of chronic periodontitis patients. The exploratory objective:To investigate the effects of human dental pulp mesenchymal stem cells on biomarkers in gingival crevicular fluid in chronic periodontitis patients.
Detailed Description
This is a multicenter, randomized, double-blind, parallel, placebo-controlled study, including three treatment groups which are single-dose group, two-dose group (low-dose), and two-dose group (high-dose). The patients of single-dose group will receive only one dose on day 1 (D1), and the patients of two-dose groups will receive one dose on D1 and D90 respectively. 68 participants will be enrolled in each group, and be randomized (3:1) to receive human dental pulp mesenchymal stem cells (hDP-MSCs) or placebo (normal saline). Participants in the single-dose group and the two-dose group (high-dose) will receive local injection of 1.0 × 107 hDP-MSCs (0.6mL normal saline suspension) / periodontal defect site or 0.6mL normal saline / periodontal defect site, and participants in the two-dose group (low-dose) will receive local injection of 1.0 × 106 hDP-MSCs (0.6mL normal saline suspension) / periodontal defect site or 0.6mL normal saline / periodontal defect site. All participants will receive basic periodontal treatment simultaneously. Dosing interval: the dosing interval is set at 89 days, which is based on the results of preclinical trials of hDP-MSCs, the improvement of periodontitis observed on D90 after hDP-MSCs administration, and good safety profile in phase 1 clinical trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Human Dental Pulp Stem Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
multicenter, randomized, double-blind, parallel, placebo-controlled study
Masking
ParticipantInvestigator
Masking Description
double-blind
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single-dose group
Arm Type
Experimental
Arm Description
Human Dental Fulp Stem Cells Injection: 1X 10^7 cells/periodontaldefect site.
Arm Title
two-dose group (low-dose)
Arm Type
Experimental
Arm Description
Human Dental Pulp Stem Cells Injection: 1X 10^6 cells/periodontaldefect site. Continuous administration twice, with an interval of 89 days between each administration.
Arm Title
two-dose group (high-dose)
Arm Type
Experimental
Arm Description
Human Dental Pulp Stem Cells Injection: 1X 10^7 cells/periodontaldefect site. Continuous administration twice, with an interval of 89 days between each administration.
Intervention Type
Drug
Intervention Name(s)
Human Dental Fulp Stem Cells
Other Intervention Name(s)
Initial periodontal therapy
Intervention Description
Investigational drugs: Based on the initial periodontal treatment (supragingival cleansing, subgingival scaling and root planning), human pulp stem cell injections will be given for a single or two local injection
Primary Outcome Measure Information:
Title
Changes from baseline in height of the periodontal bone defect
Description
Changes from baseline in height of the periodontal bone defect which will be examined by CBCT at D90±7 and D180±14 (primary efficacy endpoint)
Time Frame
at baseline, 90 days, 180 days
Secondary Outcome Measure Information:
Title
Changes from baseline in respiration rate of Vital Signs
Description
Respiratory rate, in beats per minute
Time Frame
within 180 days after administration
Title
Changes from baseline in heart rate of Vital Signs
Description
Heart rate in beats per minute
Time Frame
within 180 days after administration
Title
Changes from baseline in blood pressure of Vital Signs
Description
Blood pressure in mmHg, both systolic and diastolic blood pressure will be measured.
Time Frame
within 180 days after administration
Title
Changes from baseline in body temperature of Vital Signs
Description
Body temperature in Celsius degree
Time Frame
within 180 days after administration
Title
Changes from baseline in red blood cell count of Laboratory Examination
Description
Red blood cell count in whole blood is reported in the form of number
Time Frame
within 180 days after administration
Title
Changes from baseline in white blood cell count of Laboratory Examination
Description
White blood cell count in whole blood is reported in the form of number
Time Frame
within 180 days after administration
Title
Changes from baseline in neutrophil count of Laboratory Examination
Description
Neutrophil count in whole blood is reported in the form of number
Time Frame
within 180 days after administration
Title
Changes from baseline in lymphocyte count of Laboratory Examination
Description
Lymphocyte count in whole blood is reported in the form of number
Time Frame
within 180 days after administration
Title
Changes from baseline in platelet count of Laboratory Examination
Description
Platelet count in whole blood is reported in the form of number
Time Frame
within 180 days after administration
Title
Changes from baseline in hemoglobin of Laboratory Examination
Description
Changes of hemoglobin concentration(g/dL)in whole blood will be recorded.
Time Frame
within 180 days after administration
Title
Changes from baseline in PT of Laboratory Examination
Description
Prothrombin time (PT) is a screening test for exogenous coagulation factors
Time Frame
within 180 days after administration
Title
Changes from baseline in INR of Laboratory Examination
Description
International standardized ratio (INR) is calculated from prothrombin time and international sensitivity index (ISI) of the reagent.
Time Frame
within 180 days after administration
Title
Changes from baseline in APTT of Laboratory Examination
Description
Activated partial thromboplastin time (APTT) is a screening test for endogenous coagulation factors
Time Frame
within 180 days after administration
Title
Changes from baseline in total bilirubin of Laboratory Examination
Description
Changes of total bilirubin concentration (μmol/L) in serum will be recorded
Time Frame
within 180 days after administration
Title
Changes from baseline in direct bilirubin of Laboratory Examination
Description
Changes of direct bilirubin concentration (μmol/L) in serum will be recorded
Time Frame
within 180 days after administration
Title
Changes from baseline in ALT of Laboratory Examination
Description
Changes of ALT concentration (U/L) in serum will be recorded
Time Frame
within 180 days after administration
Title
Changes from baseline in AST of Laboratory Examination
Description
Changes of AST concentration (U/L) in serum will be recorded
Time Frame
within 180 days after administration
Title
Changes from baseline in total protein of Laboratory Examination
Description
Changes of total protein concentration (g/L) in serum will be recorded
Time Frame
within 180 days after administration
Title
Changes from baseline in albumin of Laboratory Examination
Description
Changes of albumin concentration (g/L) in serum will be recorded
Time Frame
within 180 days after administration
Title
Changes from baseline in total bile acid of Laboratory Examination
Description
Changes of total bile acid concentration (μmol/L) in serum will be recorded
Time Frame
within 180 days after administration
Title
Changes from baseline in urea of Laboratory Examination
Description
Changes of urea concentration (mmol/L) in serum will be recorded
Time Frame
within 180 days after administration
Title
Changes from baseline in creatinine of Laboratory Examination
Description
Changes of creatinine concentration (μmol/L) in serum will be recorded
Time Frame
within 180 days after administration
Title
Changes from baseline in uric acid of Laboratory Examination
Description
Changes of uric acid concentration (μmol/L) in serum will be recorded
Time Frame
within 180 days after administration
Title
Changes from baseline in glucose of Laboratory Examination
Description
Changes of glucose concentration (mmol/L) in serum will be recorded
Time Frame
within 180 days after administration
Title
Changes from baseline in potassium of Laboratory Examination
Description
Changes of potassium concentration (mmol/L) in serum will be recorded
Time Frame
within 180 days after administration
Title
Changes from baseline in sodium of Laboratory Examination
Description
Changes of sodium concentration (mmol/L) in serum will be recorded
Time Frame
within 180 days after administration
Title
Changes from baseline in chlorine of Laboratory Examination
Description
Changes of chlorine concentration (mmol/L) in serum will be recorded
Time Frame
within 180 days after administration
Title
Changes from baseline in Detection of infectious diseases of Laboratory Examination
Description
It refers to infectious diseases screening
Time Frame
within 180 days after administration
Title
Changes from baseline in IgA of Laboratory Examination
Description
Changes of IgA concentration (g/L)in serum will be recorded
Time Frame
within 180 days after administration
Title
Changes from baseline in IgG of Laboratory Examination
Description
Changes of IgG concentration (g/L)in serum will be recorded
Time Frame
within 180 days after administration
Title
Changes from baseline in IgM of Laboratory Examination
Description
Changes of IgM concentration (g/L)in serum will be recorded
Time Frame
within 180 days after administration
Title
Changes from baseline in total IgE of Laboratory Examination
Description
Changes of total IgE concentration (g/L)in serum will be recorded
Time Frame
within 180 days after administration
Title
Changes from baseline in Pregnancy test of Laboratory Examination
Description
Pregnancy test will be tested in female subjects
Time Frame
within 180 days after administration
Title
Changes from baseline in urine specific gravity of Laboratory Examination
Description
Changes of urine specific gravity will be recorded
Time Frame
within 180 days after administration
Title
Changes from baseline in urine pH of Laboratory Examination
Description
Changes of urine pH value will be recorded
Time Frame
within 180 days after administration
Title
Changes from baseline in urine glucose of Laboratory Examination
Description
Changes of urine glucose will be examined by qualitative test (positive or negative)
Time Frame
within 180 days after administration
Title
Changes from baseline in urine protein of Laboratory Examination
Description
Changes of urine protein will be examined by qualitative test (positive or negative)
Time Frame
within 180 days after administration
Title
Changes from baseline in urine ketone body of Laboratory Examination
Description
Changes of urine ketone body will be examined by qualitative test (positive or negative)
Time Frame
within 180 days after administration
Title
Changes from baseline in urine white blood cell of Laboratory Examination
Description
Changes of white blood cell in urine will be examined by qualitative test (positive or negative)
Time Frame
within 180 days after administration
Title
Changes from baseline in urine bilirubin of Laboratory Examination
Description
Changes of urine bilirubin will be examined by qualitative test (positive or negative)
Time Frame
within 180 days after administration
Title
Changes from baseline in urine occult blood of Laboratory Examination
Description
Changes of urine occult blood will be examined by qualitative test (positive or negative)
Time Frame
within 180 days after administration
Title
Changes from baseline in ECG PR interval
Description
The cardiac rhythm is showed in 12 Leads Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded.
Time Frame
within 180 days after administration
Title
Changes from baseline in ECG QRS interval
Description
The cardiac rhythm is showed in 12 Leads Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded.
Time Frame
within 180 days after administration
Title
Changes from baseline in ECG RR interval
Description
The cardiac rhythm is showed in 12 Leads Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded.
Time Frame
within 180 days after administration
Title
Changes from baseline in ECG QT interval
Description
The cardiac rhythm is showed in 12 Leads Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded.
Time Frame
within 180 days after administration
Title
Incidence of Treatment-Emergent Adverse Event
Description
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events during the study period, and the severity of adverse events is determined according to the NCI CTCAE version 5.0
Time Frame
within 180 days after administration
Title
Change from baseline in Clinical Attachment Level (AL)
Description
Clinical Attachment Level (AL) may be assessed to the nearest millimeter by means of a graduated probe and expressed as the distance in millimeters from the CEJ to the bottom of the probeable gingival/periodontal pocket
Time Frame
at baseline, 90 days, 180 days
Title
Change from baseline in Tooth Mobility (TM)
Description
The continuous loss of the supporting tissues during periodontal disease progression may result in increased tooth mobility, which is divided into 3 degree: I°, II°, and III°. Changes from baseline in tooth mobility will be recorded
Time Frame
at baseline, 90 days, 180 days
Title
Change from baseline in Probing Depth (PD)
Description
The probing depth is the distance from the gingival margin to the bottom of the gingival sulcus/pocket, is measured to the nearest millimeter by means of periodontal probe
Time Frame
at baseline, 90 days, 180 days
Title
Change from baseline in Gingival recession (GR)
Description
Exposure of the tooth through apical migration of the gingiva is called gingival recession. Recorded as the distance in millimeters from the CEJ to the gingival margin
Time Frame
at baseline, 90 days, 180 days
Title
Change from baseline in Probing bleeding on probing (BOP)
Description
A periodontal probe is inserted to the "bottom" of the gingival/periodontal pocket applying light force and is moved gently along the tooth (root) surface. If bleeding is provoked by this examination, the site examined is considered bleeding on probing-positive and, hence, inflamed. Probing Bleeding Index is divided into 5 grades: 0, 1, 2, 3 and 4.
Time Frame
at baseline, 90 days, 180 days
Other Pre-specified Outcome Measures:
Title
Change from baseline in interleukin-6 (IL-6)
Description
Changes in IL-6 baseline will be confirmed through gingival crevicular fluid detection at D90 D180 D360 and D720
Time Frame
at baseline, 90 days, 180 days,360 days,720 days
Title
Change from baseline in tumor necrosis factor-alpha (TNF-α)
Description
Changes in TNF-α baseline will be confirmed through gingival crevicular fluid detection at D90 D180 D360 and D720
Time Frame
at baseline, 90 days, 180 days,360 days,720 days
Title
Change from baseline in matrix metalloproteinase-8 (MMP-8)
Description
Changes in MMP-8 baseline will be confirmed through gingival crevicular fluid detection at D90 D180 D360 and D720
Time Frame
at baseline, 90 days, 180 days,360 days,720 days
Title
Change from baseline in interleukin-1beta (IL-1β)
Description
Changes in IL-1β baseline will be confirmed through gingival crevicular fluid detection at D90 D180 D360 and D720
Time Frame
at baseline, 90 days, 180 days,360 days,720 days
Title
Change from baseline in osteoprotegerin (OPG)
Description
Changes in OPG baseline will be confirmed through gingival crevicular fluid detection at D90 D180 D360 and D720
Time Frame
at baseline, 90 days, 180 days,360 days,720 days
Title
Changes from baseline in height of the periodontal bone defect
Description
Changes from baseline in height of the periodontal bone defect which will be examined by CBCT at D360 and D720
Time Frame
at baseline, 360 days,720 days
Title
Change from baseline in Clinical Attachment Level (AL)
Description
Clinical Attachment Level (AL) may be assessed to the nearest millimeter by means of a graduated probe and expressed as the distance in millimeters from the CEJ to the bottom of the probeable gingival/periodontal pocket
Time Frame
at baseline, 360 days,720 days
Title
Change from baseline in Probing Depth (PD)
Description
The probing depth is the distance from the gingival margin to the bottom of the gingival sulcus/pocket, is measured to the nearest millimeter by means of periodontal probe
Time Frame
at baseline, 360 days,720 days
Title
Change from baseline in Tooth Mobility (TM)
Description
The continuous loss of the supporting tissues during periodontal disease progression may result in increased tooth mobility, which is divided into 3 degree: I°, II°, and III°. Changes from baseline in tooth mobility will be recorded
Time Frame
at baseline, 360 days,720 days
Title
Change from baseline in Gingival recession (GR)
Description
Exposure of the tooth through apical migration of the gingiva is called gingival recession. Recorded as the distance in millimeters from the CEJ to the gingival margin
Time Frame
at baseline, 360 days,720 days
Title
Change from baseline in Probing bleeding on probing (BOP)
Description
A periodontal probe is inserted to the "bottom" of the gingival/periodontal pocket applying light force and is moved gently along the tooth (root) surface. If bleeding is provoked by this examination, the site examined is considered bleeding on probing-positive and, hence, inflamed. Probing Bleeding Index is divided into 5 grades: 0, 1, 2, 3 and 4.
Time Frame
at baseline, 360 days,720 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1)18 to 65 years old (including threshold), unlimited gender; 2)Radiological examination of the periodontal defect site shows angular bone defect; 3)The probing depth (PD) at the periodontal defect site is 4 to 8 mm at baseline; 4)Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures; 5)Voluntarily participate in the clinical study, understand and sign the informed consent; Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Participants with severe periodontal diseases (alveolar bone resorption exceeds two-thirds of the tooth root length) which affect the investigator's judgment; The grade of studied tooth looseness ≥ grade 3 at baseline (only buccolingual movement is defined as grade 1; buccolingual and mesiodistal movement is grade 2; vertical loosening is grade 3); The studied tooth with occlusal trauma which affect the investigator's judgment; Participants with surgical treatment of previous periodontal defect sites and adjacent periodontal tissues; Participants with non-steroid anti-inflammatory drug, steroid hormone therapy, and/or other hormone (except topical hormones) treatment within past 3 months of the screening visit, and/or previous use of bisphosphonates; Participants with severe systemic infection within past 3 months of the screening visit, or antibiotics treatment within past 72h of the screening visit; Participants with uncontrolled hypertension within 1 month before screening (defined as sitting systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg after receiving the optimal antihypertensive therapy); Participants with severe or uncontrolled diseases in any system (cardiac, hepatic, renal, respiratory, hematologic, endocrine, nervous, or psychiatric); Participants are known to be allergic to any materials that may be used during surgery (allergy-prone constitution or history of allergy to blood products); Any of the following abnormalities in clinical laboratory tests at screening: ALT > 3 ULN, total bilirubin > 1.5 ULN, serum creatinine > 1.5 ULN, international normalized ratio (INR) ≥ 1.5 ULN or activated partial thromboplastin time (APTT) ≥ 1.5 ULN (except for patients receiving anticoagulation therapy), Hb < 80 g/L, or PLT < 75.0×109/L; Positive result for any of the following tests at screening: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (TP-Ab); Females who are pregnant or breastfeeding; Participants and their partners who plan to conceive or do not agree to use the effective non-pharmacological method of contraceptive during the trial from screening visit to 6 months after the end of the trial; Participants participated in other clinical studies within past 3 months of the screening visit; Participants with a history of smoking addiction within past 12 months of the screening visit (the number of cigarettes smoked per day ≥ 10); Other circumstances deemed inappropriate by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao Wang, Master
Phone
+86 010-82266334
Email
bysykqpeking@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao Wang, Master
Organizational Affiliation
Department of Stomatology, Peking University Third Hospital, Beijing, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijng
ZIP/Postal Code
100191
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Human Dental Pulp Mesenchymal Stem Cells for the Treatment of Chronic Periodontitis Patients

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