JPRN-jRCTb040230035
Recruiting
Phase 1
A clinical study of bone regeneration using autologous dental pulp stem cells
Yamada Yoichi0 sites5 target enrollmentJune 12, 2023
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Yamada Yoichi
- Enrollment
- 5
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Patients who are capable of making an independent decision to comply with trial requirements and whose informed consents are obtained by oral and written document.
- •(2\) Male and female
- •(3\) Age \>\=20\-years\-old and \<\=70\-years\-old
- •(4\) Patients who have unnecessary and/or discarded teeth such as wisdom tooth, expendientry extracted tooth for orthodontic treatment, supernumerary tooth or displaced tooth without occlusion to supply pulp tissue.
- •(5\) Patients who wish to have dental implant treatment rather than conventional removable prostheses or conserve teeth.
- •(6\) Patients who would require bone transplantation for dental implant because of severe alveolar ridge atrophy. (The width of alveolar bone at the installation sites is \<\= 5 mm. In the maxilla, the distance between the alveolar ridge and the sinus floors is \<\= 5 mm. On the other hand, in the mandible the distance between the ridge and mandibular canal is\<\= 5 mm.) Finally it is decided by CT evaluation.
- •(7\) Patients that oral hygiene is well established.
- •(8\) Patients who are able to visit their hospitals in accordance with the trial schedule.
Exclusion Criteria
- •(1\) Patients who have a difficulty in collecting blood. (hemoglobin content \<11g/dl, blood platelet count \<\=100,000/mm3\)
- •(2\) Patients who suffer from infectious diseases (positive for HBs antigen, HBc antibody, HCV antibody, HIV antibody, HTLV\-1 antibody, and syphilis serology).
- •(3\) Patients with coexisting disorder of the blood, circulatory system, kidney, and/or liver.
- •(4\) Patients taking anticoagulants or antiplatelet agents.
- •(5\) Patients with coexisting diabetes.
- •(6\) Patients with coexisting osteoporosis.
- •(7\) Patients who have mental or consciousness disorder, the history of dependence on alcohol or drugs.
- •(8\) Patients who are either pregnant, possibly pregnant, or who hope to become pregnant during the period of this trial.
- •(9\) Patients who have a previous history of allergy to any antimicrobial agent or local anesthesia.
- •Others who the investigators determined as unsuitable for the trial.
Outcomes
Primary Outcomes
Not specified
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