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Regeneration of Pulp-Dentin Development in Teeth With Necrotic Pulps and Immature Roots

NCT01976065 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2023-09-07

No results posted yet for this study

Summary

This multi-center exploratory clinical trial is a randomized trial designed to test whether a regenerative endodontic procedure using tissue engineering principles (REGENDO), or a revascularization (REVASC) endodontic procedure, in comparison to standard apexification treatment using a mineral trioxide aggregate barrier (apexification; APEX), produces a significantly better composite clinical outcome for the treatment of immature permanent teeth with pulpal necrosis.

Conditions

  • Pulp Necrosis
  • Regeneration

Interventions

DRUG

Triple Antibiotic Paste

USP antibiotic drugs mixed at a 1:1:1 ratio into a powder that is mixed with sterile saline to a paste-like consistency

OTHER

Standard Treatment

Standard Treatment no use of study drug

Sponsors & Collaborators

  • University of Maryland, Baltimore

    collaborator OTHER

  • Loma Linda University

    collaborator OTHER

  • University of North Carolina

    collaborator OTHER

  • American Association of Endodontists

    collaborator OTHER

  • Kenneth Hargreaves

    lead OTHER

Principal Investigators

  • Kenneth Hargreaves, DDS, PhD · University of Texas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
6 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2018-09-24
Completion
2018-09-24

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01976065 on ClinicalTrials.gov