Phase
Condition
Periodontitis
Treatment
Human Dental Fulp Stem Cells
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participants are eligible to be included in the study only if all of the followingcriteria 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
Exclusion Criteria:
- Participants are excluded from the study if any of the following criteria apply:
Participants with severe periodontal diseases (alveolar bone resorption exceedstwo-thirds of the tooth root length) which affect the investigator's judgment;
The grade of studied tooth looseness ≥ grade 3 at baseline (only buccolingualmovement 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'sjudgment;
Participants with surgical treatment of previous periodontal defect sites andadjacent periodontal tissues;
Participants with non-steroid anti-inflammatory drug, steroid hormone therapy,and/or other hormone (except topical hormones) treatment within past 3 monthsof the screening visit, and/or previous use of bisphosphonates;
Participants with severe systemic infection within past 3 months of thescreening visit, or antibiotics treatment within past 72h of the screeningvisit;
Participants with uncontrolled hypertension within 1 month before screening (defined as sitting systolic blood pressure ≥ 160 mmHg or diastolic bloodpressure ≥ 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 duringsurgery (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 partialthromboplastin time (APTT) ≥ 1.5 ULN (except for patients receivinganticoagulation therapy), Hb < 80 g/L, or PLT < 75.0×109/L;
Positive result for any of the following tests at screening: hepatitis Bsurface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), humanimmunodeficiency 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 theeffective non-pharmacological method of contraceptive during the trial fromscreening visit to 6 months after the end of the trial;
Participants participated in other clinical studies within past 3 months of thescreening visit;
Participants with a history of smoking addiction within past 12 months of thescreening visit (the number of cigarettes smoked per day ≥ 10); Othercircumstances deemed inappropriate by the investigator.
Study Design
Study Description
Connect with a study center
Peking University Third Hospital
Beijing, Beijng 100191
ChinaActive - Recruiting
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