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Clinical Trial 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.


Clinical Trial Description

This is a multi-center randomized clinical trial designed to test whether a regenerative endodontic procedure using tissue engineering principles (REGENDO), or a revascularization (REVASC) endodontic procedure, when compared to the standard apexification treatment using mineral trioxide aggregate barrier-MTA apexification (APEX), produces a significantly better composite clinical outcome for the treatment of immature permanent teeth with pulpal necrosis. This study will use an antibiotic mixture called Triple Antibiotic Paste (TAP), consisting of ciprofloxacin, metronidazole and minocycline, in the tooth for disinfection of the root canal in study arms REGENDO and REVASC. The FDA has issued an Investigational New Drug (IND) number allowing use of the triple antibiotic mixture in this trial. Other dental materials used in this study have already been FDA approved for use in humans to provide a matrix for the promotion of tissue growth in the root canal space. The study will also attempt to identify the type of bacteria within the root canal space and surrounding tissues by analyzing a small sample collected on a cotton-tip applicator. This clinical trial hopes to determine which of the three treatment methods helps the tooth to grow stronger and survive for at least two years after treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01976065
Study type Interventional
Source The University of Texas Health Science Center at San Antonio
Contact
Status Completed
Phase Phase 1
Start date September 2014
Completion date September 24, 2018

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03763110 - Photo-Activated Disinfection Versus Triple-Antibiotic Paste for Management of Necrotic Young Permanent Anterior Teeth N/A
Completed NCT00881907 - Tissue Characterization in Teeth Treated With a Regeneration Protocol Phase 0
Recruiting NCT04313010 - Effectiveness of Regenerative Endodontics Therapy for Single-rooted Mature Permanent Tooth With Pulp Necrosis N/A
Not yet recruiting NCT03813433 - Discoloration of Endosequence and Mineral Trioxde Aggregate in Revascularization of Necrotic Immature Permanent Teeth N/A
Completed NCT03589560 - Evaluation of Biodentine and Mineral Trioxide Aggregate in Revascularization of Non Vital Immature Anterior Teeth N/A
Not yet recruiting NCT03717337 - Success Rate of Single Versus Two Visit Regenerative Treatment Protocol in Non Vital Mature Anterior Teeth N/A
Completed NCT01817413 - Comparison of Two Dental Techniques Used to Treat Teeth Which Have Become Infected or Painful Following Trauma Phase 4
Completed NCT03849222 - Evaluation the Effect of Using of Apical Matrix With Apexification Procedure on Apical Healing of Necrotic Immature Teeth Phase 2/Phase 3
Completed NCT00881491 - Treatment Outcome With a Revascularization Protocol Using the Triple Versus Double Antibiotic Paste Phase 0