Irreversible pulpitis or Apical periodontitis
Conditions
Interventions
Allogeneic dental pulp stem cells are transplanted into the root canals of the affected tooth
Sponsors
Nakashima Misako
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for the recipients (1)The patient must have an irreversible pulpitis or an apical periodontitis. (2)Over 18 years old (3)The patient must not have wisdom teeth not involved in occlusion that are easily extracted,or excessive or displaced teeth, and teeth extracted for convenience of orthodontic reason. (4)Dental radiographs or CBCT must show enough residual sound dentin above the bone edge, and the affected tooth must be able to completely prevent microleakage into the root canal by means of a resin septum or other means. (5)Blood and urine tests performed within 14 days prior to transplantation are within normal limits. (6)No root fracture should be observed in the affected tooth. (7)Excessive mobility (mobility class III) should not be observed in the affected tooth. (8)No history of dislocation in the affected tooth. (9)Sound natural tooth structure remaining in the affected tooth that is restorable by final restoration/prosthesis. (10)The affected tooth must have a natural tooth structure to which the probe tip of the pulp tester can be applied, and responsive to the electric pulp test. (11)The affected tooth is not covered by a ceramic dental material that prevents transmittion of cold or hot stimuli, and allows cold and hot tests possible. (12)No artifacts on MRI or CBCT images to assess pulp regeneration. (13)The patient must not have serious systemic complications such as diabetes, immunodeficiency, leukemia, etc. (14)The absence of any infectious diseases assessed by serological tests for common infectious agents performed within 14 days prior to transplantation. (15)The patient signed the informed consent.
Exclusion criteria
Exclusion criteria: Exclusion criteria for the recipients (1) The autologous dental pulp stem cells are available for the patient . (2) Patients for whom a MRI examination is not feasible. (3) Patients with cancerous conditions or suspected malignant tumors. (4) Patients undergoing or suspected to be undergoing treatment for hematological diseases and autoimmune diseases (connective tissue disease, rheumatoid arthritis, etc.) and patients requiring steroid therapy other than these diseases. (5) Patients with serious metabolic/endocrine diseases (diabetes, hyperthyroidism/hypothyroidism, etc.), cardiovascular diseases, osteoporosis, and liver diseases. (6) The patient who are pregnant or may become pregnant, and hope to become pregnant during the study period. (7) Patients with a history of drug hypersensitivity. (8) Patients with a history of allergy to antimicrobial agents or local anesthetics. (9) The patient whose affected tooth is failed to disinfect the root canal within the specified period in the root canal treatment prior to cell transplantation. (10) The patient whose affected tooth is failed to remove a foreign body and establish apical patency in the root canal treatment prior to cell transplantation. (11)The patients undergoing orthodontic treatment or scheduled for orthodontic treatment within 2 years. (12)The patient whose ability to sign the informed consent may be affected. (13)Other patients who are deemed inappropriate by the project manager or other relevant personnel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following endpoints will be evaluated for safety by statistically processing data on signs,symptoms,and disease examination data observed in the following endpoints,as well as by evaluating the results individually and comprehensively from a clinical perspective. (1) Vital signs (body temperature, systolic and diastolic blood pressure,pulse rate) (2) Clinical laboratory test values (white blood cell count,white blood cell fraction, CRP,total bilirubin) (3) Oral findings (fistula,drainage of pus,root apex swelling) (4)Local findings (NRS score for spontaneous pain,tenderness, percussion pain, occlusal pain) (5) Enlarged periapical lesion (periapical radiolucency) examined by periapical radiographs(CBCT) (6) Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| A comprehensive clinical diagnosis of the efficacy of the treatment on each affected tooth is performed using the following endpoints. (1) Pulp sensitivity test (electric pulp test, cold test and hot test). (2) Signal intensity by MRI of the regenerated tissue (3) Apical lesion volume (4) Root canal volume in the root canal | — |
Countries
Japan
Contacts
Public ContactKaori Abe
Future Health Medical Corporation RD Dental Clinic
Outcome results
None listed