NCT01976065

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Kenneth Hargreaves · Academic / Other
• Sex: All
• Age: 6 Years – 20 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Pulp Necrosis
• Regeneration

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-09-01
• Primary completion: 2018-09-24
• Completion: 2018-09-24
• First posted: 2013-11-05
• Last updated: 2023-09-07

Locations

4 sites across 1 country: United States