N-Acetyl Cysteine Protects Pulpal Stem Cells in Endodontic Revascularization

Stopped early · Early Phase 1

Conditions studied: Endodontic Disease

In brief

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.

Key facts

Study ID

NCT03451435

Run by

University of California, Los Angeles

People needed

7

Starts

2018-06-15

Expected to finish

2019-04-01

Last updated by the study team

2026-01-21

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Inclusion criteria include the following:
• 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
• Vitality tests (cold testing with Endo ice and Electric pulp testing) will determine the tooth to be necrotic 3) Palpation and percussion tests may or may not be positive 4) Probings will be within 1-5mm 5) Patient will commit to coming to 2-3 treatment appointments lasting 1-3 hours each. Thereafter, patient will commit to come for followup recall appointments 6 and 12 months following last treatment appointment.
• Patient must be able to tolerate sitting in a dental chair for 1-3 hours. 7) Patient will be in the age range of 6 to 18 years

You may not qualify if…

• Exclusion criteria include patients who cannot tolerate sitting in a dental chair due to anxiety for 1-2 hours.

Where it is running

• University of California, Los Angeles Dept of Graduate Endodontics — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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