4.7 Article

Needle-free Mental Incisive Nerve Block: In vitro, Cadaveric, and Pilot Clinical Studies

期刊

出版社

ELSEVIER
DOI: 10.1016/j.ijpharm.2021.121197

关键词

Dental anesthesia; Mental nerve; Jet injections; Pilot studies; Feasibility studies; Randomized controlled trial; Paresthesia

资金

  1. Canada's Natural Sciences and Engineering Research Council [543972-19, 366077487]
  2. National Institutes of Health (NIH) [R01 DC0R01DC018577]
  3. Clifford C.F. Wong Fellowship, reseau de Recherche en Sante Buccodentaire et Osseuse
  4. Alpha-OmegaFoundation of Canada from McGill University
  5. Chinese Scholarship Council

向作者/读者索取更多资源

The study showed that adjusting the supply pressure of NFLJI can achieve effective Mental Incisive Nerve Blocks with minimal complications and improved success rates. High-pressure NFLJI poses higher risks of discomfort and paresthesia, while low-pressure NFLJI is less likely to cause complications.
The present study aimed to optimize Needle-Free Liquid Jet Injection (NFLJI) for Mental Incisive Nerve Blocks (MINB) and evaluate its clinical safety and feasibility. A MINB protocol was developed and optimized by series of NFLJI experiments in soft tissue phantoms and cadavers, then validated in two pilot Randomized Controlled Trials (RCT). The NFLJI penetration depth was found to be directly proportional to the supply pressure and volume. High-pressure NFLJIs (620 kPa or above) created maximum force and total work significantly greater than needle injections. Low-pressure NFLJIs (413 kPa), however, produced results similar to those of needle injections. Additionally, high-pressure NFLJIs created jet impingement pressure and maximum jet penetration pressure higher than low-pressure NFLJIs. Pilot RCTs revealed that high-pressure NFLJI caused a high risk of discomfort (60%) and paresthesia (20%); meanwhile, low-pressure NFLJI was less likely to cause complications (0%). The preliminary success rates of MINB from cadavers using NFLJIs and needles were 83.3% and 87.5%. In comparison, those from RCTs are 60% and 70%, respectively. To conclude, NFLJI supply pressure can be adjusted to achieve effective MINB with minimal complications. Furthermore, the cadaver study and pilot RCTs confirmed the feasibility for further non-inferiority RCT.

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