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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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.
Henry M Goldman School of Dental Medicine
Boston, Massachusetts, United States
periradicular bone healing
Bone healing will be determined by calculating the difference in the bone thickness in millimeters comparing baseline to 24 months on radiographs
Time frame: 24 months
periradicular bone infection
Assess and document any signs/symptoms of infection at the second visit
Time frame: 1-4 weeks after first visit
tooth root thickness at 12 months
The tooth root thickness will be measured in millimeters, comparing the pre-procedure radiographs and Cone-Beam-Computed Tomography scans (CBCT) to radiographs and CBCT at 12 months
Time frame: 12 months
tooth root thickness at 24 months
The tooth root thickness will be measured in millimeters, comparing the pre-procedure radiographs and Cone-Beam-Computed Tomography scans (CBCT) to radiographs and CBCT at 24 months
Time frame: 24 months
tooth root length at 12 months
The tooth root length will be measured in millimeters, comparing the pre-procedure radiographs and Cone-Beam-Computed Tomography scans (CBCT) to radiographs and CBCT at 12 months
Time frame: 12 months
tooth root length at 24 months
The tooth root length will be measured in millimeters, comparing the pre-procedure radiographs and Cone-Beam-Computed Tomography scans (CBCT) to radiographs and CBCT at 24 months
Time frame: 24 months
tooth vitality at 12 months
A pain response to hot/cold and electrical pulp tester will be done to test the vitality of the tooth pulp at 12 months
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Time frame: 12 months
tooth vitality at 24 months
A pain response to hot/cold and electrical pulp tester will be done to test the vitality of the tooth pulp at 24 months
Time frame: 24 months