JPRN-jRCTb050220181
Recruiting
Phase 2
Development of periodontal tissue regeneration therapy using an autologous adipose tissue-derived multi-lineage progenitor cells - Development of periodontal tissue regeneration therapy using an autologous ADMPC
Murakami Shinya0 sites30 target enrollmentMarch 1, 2023
Conditionssevere periodotitis
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- severe periodotitis
- Sponsor
- Murakami Shinya
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Patients over 20 years old at the time of consent acquisition.
- •2\) Patients with test teeth that meet all of the following criteria.
- •1\. Teeth diagnosed with severe periodontitis (teeth meet at least one of the following criteria, 33% or more alveolar bone resorption, 5mm or more clinical attachment loss , 6mm or more probing pocket depth) at the initial visit.
- •2\. Teeth with vertical bone defects of 2mm or more in width on its mesial or distal site, or with one\- or four\-wall bone defects less than 4mm depth and less than 2mm wide.
- •3\. Teeth with tooth mobility of 2 degree or less, and with keratinized gingiva that are judged to be capable of flap operation.
- •3\) Patients who have received the initial periodontal therapy.
- •4\) Patients whose oral hygiene is established, are determined to be able to maintain good oral hygiene under the guidance of dentists after the treatment of regenerative medicine.
- •5\) Patients who have written consent to participate in this clinical study.
Exclusion Criteria
- •1\) Patients who have a prosthesis that interferes with the accurate measurement of the clinical attachment level of the test site.
- •2\) Patients with or have a history of malignant tumors.
- •3\) Patients with malignant tumors, precancerous lesions or suspected findings in the oral cavity in the oral diagnosis before registration.
- •4\) Patients who have used or plan to use bisphosphonates.
- •5\) Patients who need to undergo treatment that affects the evaluation of the test site within 36 weeks after stem cell transplantation.
- •6\) Patients who are pregnant, breastfeeding, wish to become pregnant by 36 weeks after transplantation, or may be pregnant (determined by pre\-registration pregnancy test).
- •7\) Patients with severe blood disorders or bone\-targeted hormone metabolic disorders.
- •8\) Patients with abnormalities in calcium metabolism organs such as kidneys and digestive organs or suspected connective tissue disease.
- •9\) Patients undergoing dialysis or receiving steroids.
- •10\) Patients with unmanageable comorbidities that limit compliance with clinical research requirements.
Outcomes
Primary Outcomes
Not specified
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