Summary

for people ages 18 years and up (full criteria)
healthy people welcome
study started
estimated completion
Mike Sabeti, DDS

Description

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.

Official Title

Effect of Residual Dental Pulp Tissue and Cord Blood Stem Cells on Regeneration of Dental

Details

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.

Keywords

Irreversible Pulpitis Pulpal regeneration Stem cells Residual Pulpal Tissue Pulpitis Pharmaceutical Solutions Cord blood stem cells Saline solution

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Patients must be systemically healthy, Class I dental category. B. Involved teeth must have no periodontal disease detectible by periodontal examination.
  2. Patients must present without radiographic signs of endodontic disease (i.e. no periapical radiolucencies).

You CAN'T join if...

  1. 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.
  2. Pregnant or nursing mothers because hormonal factors may influence the condition.
  3. Allergies or adverse reactions to local anesthetic medications G. Patients under the age of 18. H. Patients with an ASA Classification II or higher

Lead Scientist

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04040127
Phase
Phase 2
Study Type
Interventional
Last Updated