A clinical bone regeneration study with dental pulp stem cells

JRCT ID: jRCTb040230035

Registered date:12/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atrophy of alveolar bone
• Date of first enrollment: 12/06/2023
• Target sample size: 5
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Transplantation of dental pulp stem cells

Outcome(s)

• Primary Outcome: Safety
• Secondary Outcome: Efficacy of bone regeneration

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 70age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Yamada Yoichi