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A clinical bone regeneration study with dental pulp stem cells

A clinical study of bone regeneration using autologous dental pulp stem cells

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTb040230035
Enrollment
5
Registered
2023-06-12
Start date
2023-06-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrophy of alveolar bone

Interventions

Sponsors

Yamada Yoichi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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 uncontrolled 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.

Design outcomes

Primary

MeasureTime frame
Safety

Secondary

MeasureTime frame
Efficacy of bone regeneration

Countries

Japan

Contacts

Public ContactAkinori Nagai

Gifu University Hospital

hpkanri@gifu-u.ac.jp+81-58-230-6011

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026