NCT03425123

Endodontic Regenerative Procedure for Immature Non-vital Teeth

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boston University · Academic / Other
• Sex: All
• Age: 7 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

In this clinical trial the investigators will evaluate an alternate treatment option, which was developed for teeth with incomplete roots, called Regenerative Endodontic Procedure (REP). This treatment works by harnessing the blood clot formed within the root canal from tissues surrounding the root as a scaffold for stem cells. These cells could help to increase the thickness and length of the root canal walls resulting in root end maturation. Results from the 50 participants who will receive the REP treatment will be compared with findings with historical data.

Detailed description

All participants will be prospectively assigned to the REP treatment group. Results from the treatment group will be compared to historical controls of all subjects treated by Ca(OH)2 or MTA apexification in the last 10 years (2007-2017) at the Boston University Henry M Goldman School of Dental Medicine. All materials used in this protocol are FDA approved and commercially available for similar applications. This study does not seek a new use or application of any materials, instead recommendations of the American Association of Endodontists (AAE) will be followed to evaluate outcomes associated with the REP compare to the standard of care Ca(OH)2 or MTA apexification. The overall objective for this research is the elimination of any clinical symptoms and the evidence of bony healing as examined by radiographs. Other objectives include increased root wall thickness and/or increased root length and positive response to vitality testing, which if achieved, could indicate a more organized vital pulp tissue.

Conditions

• Tooth, Nonvital

Interventions

Type	Name	Description
OTHER	Regenerative Endodontic Procedure (REP)	Regenerative Endodontic Procedure (REP) involves disinfection of the root canal with the use of acombination of three antibiotics including ciprofloxacin, metronidazole, minocycline. At the second visit, the patient is evaluated for resolution of signs or symptoms of an acute infection and if none then bleeding is induced, the site covered with a plug and the patient is evaluated at follow up.

Timeline

• Start date: 2019-06-01
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2018-02-07
• Last updated: 2019-05-03

Locations

1 site across 1 country: United States