The purpose of this investigation is to assess the use of a novel scaffold (an FDA-approved collagen-hydroxyapatite material called Syn-Oss) for regeneration of pulp tissues versus the use of a traditional scaffold (blood clot).
Regeneration of pulp tissues in teeth with immature roots is a new concept based on historical limited success using calcium hydroxide dressings placed into debrided pulp spaces. Obtaining stem cells from the apical papilla (SCAP cells), which are present at the base of all teeth, but are most accessible in teeth with immature apices, greatly enhances clinical success. Current therapies lack ideal messenger chemicals and scaffolds to optimize results.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
The aim of this study is to add to the existing body of regenerative endodontics research by providing human radiographic evidence for the healing process which occurs after the placement of a FDA-approved collagen-hydroxyapatite scaffold, in the use of a blood clot
Traditionally, endodontic therapy consisted of removing the infected dental pulp from the canal spaces and replacing it with an artificial substitute called gutta percha. Regenerative endodontic research efforts were originally concentrated upon treatment of the immature necrotic tooth whereby stem cells from the bone near the root end were stimulated to grow onto a blood clot scaffold created within the debrided and disinfected canal space. The hope is that the stem cells would differentiate into cells which could potentially replace the lost pulpal tissues, restoring what was lost due to infection.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Observation 1-Radiodensity at apex @ 1mm from root vertex
Grade 1 = no disruption of apical anatomy Grade 2 = Periodontal ligament (PDL) width double thickness, with intact lamina dura Grade 3 = break in lamina dura
Time frame: Month 0-3, Institutional Review Board proposal and approval
Observation 2 - Increase in dentin wall thickness. It is noted that minimal change is expected over the course of this short-term study.
Grade 1 = dentin wall thickness increased by \> 1mm Grade 2 = dentin wall thickness \< 1mm
Time frame: Months 3-6, patient recruitment and revascularization surgery in Department of Endodontics
Observation 3 - Increase in root length, in mm.
Grade 1 = root length increased \> 1 mm Grade 2 = root length increased 0-1 mm Grade 3 = root length shorter than pre-op
Time frame: Month 6-12, clinical and radiographic recall and assessment
Observation 4 - Periradicular status
Grade 1 = no periradicular radiolucency Grade 2 = periradicular radiolucency 0-1 mm in diameter Grade 3 = periradicular radiolucency \> 1 mm in diameter
Time frame: Month 13-15, data analysis and manuscript preparation
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