Tooth, Nonvital Clinical Trial
Official title:
Endodontic Regenerative Procedure for Immature Non-vital Teeth
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.
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.
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