Zero3™ Animal Trials
TriAgenics has conducted extensive animal testing (live animal and ex vivo bench-level tissue testing) to demonstrate the safety and efficacy of its Zero3 3TBA (3rd molar Tooth Bud Ablation) technology. Phase I live animal testing in 2015 demonstrated the ability to consistently perform the 3TBA procedure. TriAgenics Zero3 technology has been engineered to control all aspects of the Zero3 3TBA process to make the procedure safe, effective and simple. As demonstrated in multiple animal studies, Zero3 3TBA predictably blocks molar agenesis. Additional live animal studies are planned to optimize the thermal ablation process to minimize damage outside the tooth bud. The menu items below provide a representative overview of TriAgenics’ animal testing program. Our animal testing program will result in a request IDE application submission to the FDA in 2019.
Seat the Zero3 3TBA surgical guide
Complete an osteotomy if needed to access target tooth bud.
Insert the Zero3™ micro-ablation probe until it stops
Deliver 30 - 45 second micro-ablation
Remove the Zero3™ micro-ablation probe for a 60 to 90 second total procedure time
The following CT image time series show a sagittal (lateral) view of an unablated maxillary control molar tooth bud (upper left quadrant) and the resulting progression of tooth formation inside the molar tooth bud starting at age 8 weeks (pig animal model) to a nearly fully formed crown at age 24 weeks.
Figure 1. The unablated maxillary control molar tooth bud (circled) is approximately 6 mm in diameter at age 8 weeks with no tooth structure evident.
Figure 2. In just 4 weeks (age 12 weeks) there is initial tooth formation evident in the 14 mm diameter unablated control molar tooth bud (circled).
Figure 3. In 7 weeks (age 15 weeks) there is continued tooth formation in the 18 mm diameter unablated control molar tooth bud (circled).
Figure 4. In 12 weeks (age 20 weeks) tooth formation is progressing rapidly in the 20 mm diameter unablated control molar tooth bud (circled).
Figure 5. In 16 weeks (age 24 weeks) the crown of the tooth is nearly formed in the 22 mm diameter unablated control molar tooth bud and root formation is now starting (circled)..
The following CT image time series show a sagittal (lateral) view of an ablated mandibular molar tooth bud (lower left quadrant) at age 8 weeks (pig animal model) and the resulting post operative healing response through to age 24 weeks (16 weeks post op)
Figure 1. The ablated molar tooth bud (circled) is approximately 6 mm in diameter at age 8 weeks with no tooth structure evident at the time of ablation.
Figure 2. At 4 weeks post ablation (age 12 weeks) there is clear evidence of rapid bony infill into the bony crypt space of the prior molar tooth bud (circled).
Figure 3. At 7 weeks post ablation (age 15 weeks) the bony infill continues into the prior bony crypt area of the ablated molar tooth bud (circled).
Figure 4. At 12 weeks post ablation (age 20 weeks) there is no evidence of the prior bony crypt of the ablated molar tooth bud and the mandible remodels with growth as if though it was never present.
Figure 5. At 16 weeks post ablation (age 24 weeks) the mandible continues growing as if though no molar tooth bud were ever present.