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N-Acetyl Cysteine Protects Pulpal Stem Cells in Endodontic Revascularization

NCT03451435 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2026-01-21

No results posted yet for this study

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.

Conditions

  • Endodontic Disease

Interventions

DRUG

N acetyl cysteine

N acetyl cysteine at 20mM will be utilized as the final stage of irrigation prior to induction of bleeding during endodontic revascularization procedure.

Sponsors & Collaborators

Principal Investigators

  • David C Han, DDS, MS · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-15
Primary Completion
2019-04-01
Completion
2019-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03451435 on ClinicalTrials.gov