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NCT03451435 · ClinicalTrials.gov registry record · Early Phase 1

N-Acetyl Cysteine Protects Pulpal Stem Cells in Endodontic Revascularization

A Early Phase 1 study, sponsored by University of California, Los Angeles.

Terminated
Registry status
Early Phase 1
Development phase
7
Enrollment target

NCT03451435: Clinical Trial Early Phase 1 study, sponsored by University of California, Los Angeles.

NCT03451435 is a Early Phase 1 study that was terminated before completion, run by University of California, Los Angeles. The registered enrollment target is 7 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03451435, a Early Phase 1 study, was terminated before completion, sponsored by University of California, Los Angeles.

TERMINATED
Registry status
Early Phase 1
Development phase
7 participants
Enrollment target

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.

Primary Outcome

Change of root length in millimeters over time

Interventions

  • DRUG N acetyl cysteine

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2018-06-15
Est. Completion 2019-04-01
Phase Early Phase 1

Why NCT03451435 stopped before completion

NCT03451435 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (87% lower).

The record links to 0 conditions, and to 1 intervention - of which N acetyl cysteine is the first listed.

NCT03451435 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03451435 about?

NCT03451435 is a clinical study titled "N-Acetyl Cysteine Protects Pulpal Stem Cells in Endodontic Revascularization". 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 pote...

What is the current status of trial NCT03451435?

This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 7 participants. The study started on 2018-06-15. Estimated completion is 2019-04-01.

What interventions are being tested in trial NCT03451435?

The interventions under investigation include: N acetyl cysteine (DRUG).

Who is sponsoring clinical trial NCT03451435?

This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03451435's enrollment target sits among peer trials

7 1825th of 2000 higher than 156 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03451435, the US trial registry maintained by the National Library of Medicine. NCT03451435 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.