drugset / Trial / NCT03451435

N-Acetyl Cysteine Protects Pulpal Stem Cells in Endodontic Revascularization

NCT03451435

Phase 0 Terminated 7 enrolled University of California, Los Angeles
RandomizedParallel-groupDouble-blindTreatment

Summary

Pulp re-vascularization/regeneration is a procedure performed to allow pulpal stem cells to survive and/or differentiate to allow immature tooth root structures to grow to full maturity. Currently, the procedure includes disinfection of the necrotic root canal space and induction of bleeding to potentiate pulpal stem cell differentiation to allow root growth on an immature root. A number of studies conducted previously demonstrate that N-acetyl cysteine (NAC) potentiates differentiation of pulpal stem/stromal cells and protects pulpal cells from apoptosis. 14-18 human subjects will be recruited forming two groups where pulp re-vascularization/regeneration procedures will be performed with or without the use of NAC treatment prior to induction of bleeding. Recall follow-up appointments will be done at 6 months and 1 year post treatment with subsequent yearly appointments until full root growth has been achieved.

Timeline

Start
2018-06-15
Primary completion
2019-04-01
Completion
2019-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject N-acetylcysteine Small molecule 20 mmol Other

Indications