Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05924373

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University Third Hospital

Beijing, Beijng, 100191, China

Location status: Recruiting

Location contact

Meng Wan, doctor

CONTACT

[email protected]

+86 010-82266263

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Human Dental Fulp Stem Cells

Drug

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

Other names: Initial periodontal therapy

Primary outcomes

  1. Changes from baseline in height of the periodontal bone defect

    Time frame: at baseline, 90 days, 180 days

    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 outcomes

  1. Changes from baseline in respiration rate of Vital Signs

    Time frame: within 180 days after administration

    Respiratory rate, in beats per minute

  2. Changes from baseline in heart rate of Vital Signs

    Time frame: within 180 days after administration

    Heart rate in beats per minute

  3. Changes from baseline in blood pressure of Vital Signs

    Time frame: within 180 days after administration

    Blood pressure in mmHg, both systolic and diastolic blood pressure will be measured.

  4. Changes from baseline in body temperature of Vital Signs

    Time frame: within 180 days after administration

    Body temperature in Celsius degree

  5. Changes from baseline in red blood cell count of Laboratory Examination

    Time frame: within 180 days after administration

    Red blood cell count in whole blood is reported in the form of number

  6. Changes from baseline in white blood cell count of Laboratory Examination

    Time frame: within 180 days after administration

    White blood cell count in whole blood is reported in the form of number

  7. Changes from baseline in neutrophil count of Laboratory Examination

    Time frame: within 180 days after administration

    Neutrophil count in whole blood is reported in the form of number

  8. Changes from baseline in lymphocyte count of Laboratory Examination

    Time frame: within 180 days after administration

    Lymphocyte count in whole blood is reported in the form of number

  9. Changes from baseline in platelet count of Laboratory Examination

    Time frame: within 180 days after administration

    Platelet count in whole blood is reported in the form of number

  10. Changes from baseline in hemoglobin of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of hemoglobin concentration（g/dL）in whole blood will be recorded.

  11. Changes from baseline in PT of Laboratory Examination

    Time frame: within 180 days after administration

    Prothrombin time (PT) is a screening test for exogenous coagulation factors

  12. Changes from baseline in INR of Laboratory Examination

    Time frame: within 180 days after administration

    International standardized ratio (INR) is calculated from prothrombin time and international sensitivity index (ISI) of the reagent.

  13. Changes from baseline in APTT of Laboratory Examination

    Time frame: within 180 days after administration

    Activated partial thromboplastin time (APTT) is a screening test for endogenous coagulation factors

  14. Changes from baseline in total bilirubin of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of total bilirubin concentration (μmol/L) in serum will be recorded

  15. Changes from baseline in direct bilirubin of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of direct bilirubin concentration (μmol/L) in serum will be recorded

  16. Changes from baseline in ALT of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of ALT concentration (U/L) in serum will be recorded

  17. Changes from baseline in AST of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of AST concentration (U/L) in serum will be recorded

  18. Changes from baseline in total protein of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of total protein concentration (g/L) in serum will be recorded

  19. Changes from baseline in albumin of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of albumin concentration (g/L) in serum will be recorded

  20. Changes from baseline in total bile acid of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of total bile acid concentration (μmol/L) in serum will be recorded

  21. Changes from baseline in urea of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of urea concentration (mmol/L) in serum will be recorded

  22. Changes from baseline in creatinine of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of creatinine concentration (μmol/L) in serum will be recorded

  23. Changes from baseline in uric acid of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of uric acid concentration (μmol/L) in serum will be recorded

  24. Changes from baseline in glucose of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of glucose concentration (mmol/L) in serum will be recorded

  25. Changes from baseline in potassium of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of potassium concentration (mmol/L) in serum will be recorded

  26. Changes from baseline in sodium of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of sodium concentration (mmol/L) in serum will be recorded

  27. Changes from baseline in chlorine of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of chlorine concentration (mmol/L) in serum will be recorded

  28. Changes from baseline in Detection of infectious diseases of Laboratory Examination

    Time frame: within 180 days after administration

    It refers to infectious diseases screening

  29. Changes from baseline in IgA of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of IgA concentration （g/L）in serum will be recorded

  30. Changes from baseline in IgG of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of IgG concentration （g/L）in serum will be recorded

  31. Changes from baseline in IgM of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of IgM concentration （g/L）in serum will be recorded

  32. Changes from baseline in total IgE of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of total IgE concentration （g/L）in serum will be recorded

  33. Changes from baseline in Pregnancy test of Laboratory Examination

    Time frame: within 180 days after administration

    Pregnancy test will be tested in female subjects

  34. Changes from baseline in urine specific gravity of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of urine specific gravity will be recorded

  35. Changes from baseline in urine pH of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of urine pH value will be recorded

  36. Changes from baseline in urine glucose of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of urine glucose will be examined by qualitative test (positive or negative)

  37. Changes from baseline in urine protein of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of urine protein will be examined by qualitative test (positive or negative)

  38. Changes from baseline in urine ketone body of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of urine ketone body will be examined by qualitative test (positive or negative)

  39. Changes from baseline in urine white blood cell of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of white blood cell in urine will be examined by qualitative test (positive or negative)

  40. Changes from baseline in urine bilirubin of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of urine bilirubin will be examined by qualitative test (positive or negative)

  41. Changes from baseline in urine occult blood of Laboratory Examination

    Time frame: within 180 days after administration

    Changes of urine occult blood will be examined by qualitative test (positive or negative)

  42. Changes from baseline in ECG PR interval

    Time frame: within 180 days after administration

    The cardiac rhythm is showed in 12 Leads Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded.

  43. Changes from baseline in ECG QRS interval

    Time frame: within 180 days after administration

    The cardiac rhythm is showed in 12 Leads Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded.

  44. Changes from baseline in ECG RR interval

    Time frame: within 180 days after administration

    The cardiac rhythm is showed in 12 Leads Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded.

  45. Changes from baseline in ECG QT interval

    Time frame: within 180 days after administration

    The cardiac rhythm is showed in 12 Leads Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded.

  46. Incidence of Treatment-Emergent Adverse Event

    Time frame: within 180 days after administration

    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

  47. Change from baseline in Clinical Attachment Level (AL)

    Time frame: at baseline, 90 days, 180 days

    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

  48. Change from baseline in Tooth Mobility (TM)

    Time frame: at baseline, 90 days, 180 days

    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

  49. Change from baseline in Probing Depth (PD)

    Time frame: at baseline, 90 days, 180 days

    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

  50. Change from baseline in Gingival recession （GR）

    Time frame: at baseline, 90 days, 180 days

    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

  51. Change from baseline in Probing bleeding on probing (BOP)

    Time frame: at baseline, 90 days, 180 days

    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.

Other outcomes

  1. Change from baseline in interleukin-6 (IL-6)

    Time frame: at baseline, 90 days, 180 days，360 days，720 days

    Changes in IL-6 baseline will be confirmed through gingival crevicular fluid detection at D90 D180 D360 and D720

  2. Change from baseline in tumor necrosis factor-alpha (TNF-α)

    Time frame: at baseline, 90 days, 180 days，360 days，720 days

    Changes in TNF-α baseline will be confirmed through gingival crevicular fluid detection at D90 D180 D360 and D720

  3. Change from baseline in matrix metalloproteinase-8 (MMP-8)

    Time frame: at baseline, 90 days, 180 days，360 days，720 days

    Changes in MMP-8 baseline will be confirmed through gingival crevicular fluid detection at D90 D180 D360 and D720

  4. Change from baseline in interleukin-1beta (IL-1β)

    Time frame: at baseline, 90 days, 180 days，360 days，720 days

    Changes in IL-1β baseline will be confirmed through gingival crevicular fluid detection at D90 D180 D360 and D720

  5. Change from baseline in osteoprotegerin (OPG)

    Time frame: at baseline, 90 days, 180 days，360 days，720 days

    Changes in OPG baseline will be confirmed through gingival crevicular fluid detection at D90 D180 D360 and D720

  6. Changes from baseline in height of the periodontal bone defect

    Time frame: at baseline, 360 days，720 days

    Changes from baseline in height of the periodontal bone defect which will be examined by CBCT at D360 and D720

  7. Change from baseline in Clinical Attachment Level (AL)

    Time frame: at baseline, 360 days，720 days

    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

  8. Change from baseline in Probing Depth (PD)

    Time frame: at baseline, 360 days，720 days

    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

  9. Change from baseline in Tooth Mobility (TM)

    Time frame: at baseline, 360 days，720 days

    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

  10. Change from baseline in Gingival recession （GR）

    Time frame: at baseline, 360 days，720 days

    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

  11. Change from baseline in Probing bleeding on probing (BOP)

    Time frame: at baseline, 360 days，720 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiao Wang, Master

CONTACT

[email protected]

+86 010-82266334

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Collaborators

  • Capital Medical University

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 29, 2023
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.