TerminatedEarly Phase 1

N-Acetyl Cysteine Protects Pulpal Stem Cells in Endodontic Revascularization

Stopped: Enrollment difficulties

United States7 participantsStarted 2018-06-15

Plain-language 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.

Who can participate

Age range

6 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subjects will be self and parent-reported as healthy individuals with no significant medical issues.
. Radiographic assessment will determine that root(s) have not grown to completion

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of Root length

Timeframe: 6 months and 1 year

Trial details

NCT IDNCT03451435

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-04-01

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