N-Acetyl Cysteine Protects Pulpal Stem Cells in Endodontic Revascularization

• Status: Unknown status
• Trial end date: 2020-06-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Los Angeles
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

• Inclusion criteria include the following:

1. Subjects will be self and parent-reported as healthy individuals with no significant medical issues.

2. Radiographic assessment will determine that root(s) have not grown to completion

2) 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.

6) 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

Exclusion Criteria:

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