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N-Acetyl Cysteine Protects Pulpal Stem Cells in Endodontic Revascularization (NAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03451435
Recruitment Status : Unknown
Verified October 2019 by David C. Han, DDS, MS, University of California, Los Angeles.
Recruitment status was:  Recruiting
First Posted : March 1, 2018
Last Update Posted : October 30, 2019
Information provided by (Responsible Party):
David C. Han, DDS, MS, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Endodontic Disease Drug: N acetyl cysteine Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: N-Acetyl Cysteine Helps Pulp Stem Cells Differentiate During Endodontic Revascularization
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : June 15, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Control
No intervention will be administered in this group as it serves as a control group.
Experimental: NAC Treatment
N-Acetyl Cysteine treatment during root canal revascularization
Drug: N acetyl cysteine
N acetyl cysteine at 20mM will be utilized as the final stage of irrigation prior to induction of bleeding during endodontic revascularization procedure.

Primary Outcome Measures :
  1. Change of Root length [ Time Frame: 6 months and 1 year ]
    Change of root length in millimeters over time

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03451435

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Contact: David C Han, DDS, MS 3108254348
Contact: Anahid Jewett, PhD 3108256528

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United States, California
University of California, Los Angeles Dept of Graduate Endodontics Recruiting
Los Angeles, California, United States, 90095
Contact: David C Han, DDS, MS    310-825-4348   
Sponsors and Collaborators
University of California, Los Angeles
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Principal Investigator: David C Han, DDS, MS University of California, Los Angeles
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Responsible Party: David C. Han, DDS, MS, Research Scientist and Clinical Director, University of California, Los Angeles Identifier: NCT03451435    
Other Study ID Numbers: 17-001024
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs