N-Acetyl Cysteine Protects Pulpal Stem Cells in Endodontic Revascularization

NCT03451435 | Terminated Early Phase 1 DMC FDA Drug

• 1 other identifier: 17-001024
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change of Root length

  Change of root length in millimeters over time

  6 months and 1 year

Study Arms (2)

Control

NO INTERVENTION

No intervention will be administered in this group as it serves as a control group.

NAC Treatment

EXPERIMENTAL

N-Acetyl Cysteine treatment during root canal revascularization

Drug: N acetyl cysteine

Interventions

N acetyl cysteine DRUG

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

NAC Treatment

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles Dept of Graduate Endodontics

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• David C Han, DDS, MS

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist and Clinical Director

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: March 1, 2018
• Study Start: June 15, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)