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New treatment option for Periodontitis
Official title Human Dental Pulp Mesenchymal Stem Cells for the Treatment of Chronic Periodontitis Patients
ClinicalTrials.gov ID: NCT05924373
What this study is testing
What is Human Dental Fulp Stem Cells?
Human Dental Fulp Stem Cells is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for periodontitis.
Also referred to as Initial periodontal therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
You likely can't join if
- 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...
- The grade of studied tooth looseness ≥ grade 3 at baseline (only buccolingual movement is defined as grade 1; buccolingual and mesiodistal movement...
- 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...
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijng, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijng, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.