Clinical trial NCT04040127: Residual Dental Pulp Tissue and Cord Blood Stem Cells
Official title: Effect of Residual Dental Pulp Tissue and Cord Blood Stem Cells on Regeneration of Dental
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Irreversible Pulpitis
Keywords: Pulpal regeneration
Stem cells
Residual Pulpal Tissue
Irreversible Pulpitis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The experiments outlined in this proposal are designed to test the hypothesis that the in vivo injection of cord blood stem cells (InvitRx®) into the root canal system will facilitate teeth initially diagnosed with irreversible pulpitis, to form normal healthy pulpal tissue.
Primary purpose: TREATMENT

Brief summary: The experiments outlined in this proposal are designed to test the hypothesis that the in vivo injection of cord blood stem cells (InvitRx®) into the root canal system will facilitate teeth initially diagnosed with irreversible pulpitis, to form normal healthy pulpal tissue.

Detailed description: Patients will be recruited from the various dental clinics at UCSF (student clinic, Advanced Education in General Dentistry clinic, post-graduate endodontics clinic, etc) that meet the inclusion and exclusion criteria. Patients in the control group will have root canal therapy initiated; instrumentation and cleaning up to 4mm from the radiographic apex. Bleeding will be induced and blood clot formed 3mm from the CEJ. MTA followed by glass ionomer and composite will be placed over the clot. Patients in the experimental group will have root canal therapy initiatied; instrumentation and cleaning up to 4mm from the radiographic apex. Bleeding will be induced and blood clot formed 3mm from the CEJ. 1 cc (30 million cord blood stem cells) will then be injected into the clot formation. MTA followed by glass ionomer and composite will be placed over the clot.

Eligibility criteria: Inclusion Criteria:

A. Patients must be systemically healthy, Class I dental category. B. Involved teeth must have no periodontal disease detectible by periodontal examination.

C. Patients must present without radiographic signs of endodontic disease (i.e. no periapical radiolucencies).

Exclusion Criteria:

A. Presence of any disease or medication that alters the immune system or interferes with healing ability B. Smokers (more than 10 cigarettes per day) C. External or internal tooth resorption D. Tooth perforation from the pulp cavity through the tip of the root exposing the tissue to material in the oral cavity.

E. Pregnant or nursing mothers because hormonal factors may influence the condition.

F. Allergies or adverse reactions to local anesthetic medications G. Patients under the age of 18. H. Patients with an ASA Classification II or higher

Primary outcomes:
measure: Regeneration of pulp
timeFrame: 6-9 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Mike Sabeti, DDS
role: PRINCIPAL_INVESTIGATOR
References: