This study aimed to develop an optimal Needle-Free Liquid Jet Injection (NFLJI) technique for dental infiltration anesthesia and evaluate its clinical safety and feasibility. The fluid dynamics of NFLJI in the dentoalveolar region were investigated using soft tissue phantoms supported by rigid glass. NFLJIs were performed at different incident angles and recorded using a high-speed camera. Accordingly, an optimal NFLJI for infiltration anesthesia was developed and validated on cadavers, then assessed in two pilot Randomized Controlled Trials (RCT): one for validating the safety of optimal NFLJI technique, the other for evaluating its feasibility and safety. High-speed videos showed that perpendicular NFLJIs induced significantly more regurgitation than oblique NFLJIs, which was confirmed in cadavers. Clinical trials revealed that perpendicular NFLJIs induced a high risk of bleeding (83.3%) and laceration (83.3%), whereas oblique NFLJIs induced a low risk of bleeding (33.3%) and laceration (16.7%). Moreover, the preliminary success rates of oblique NFLJIs and needle injections were both 83.3%. The recruitment took 3–5 weeks with a rate of 100%. Oblique NFLJIs could be a promising approach for dental infiltration anesthesia, causing minimal drug regurgitation with a relatively low risk of complication. The pilot RCTs confirmed the feasibility for conducting a non-inferiority RCT.
|Original language||English (US)|
|Journal||International journal of pharmaceutics|
|State||Published - Jul 15 2021|
Bibliographical noteFunding Information:
We sincerely thank Robert L'Heureux B.S. Jamie Brisebois B.S. from the Department of Cell and Anatomy, McGill University, for organizing the cadaver experiments. We also appreciate the generosity of the body donors and their families. Our gratitude further extends to Dr. Nathalie Morin, Rosa Menale, and Ann Marie Plante, from the Faculty of Dentistry, for supporting our clinical trials; to Dr. Xiangda Cui for advising the fluid dynamic mechanism, and to Dr. Yin Zhen for drawing the figure in the graphic abstract. This research was sponsored by the Natural Sciences and Engineering Research Council of Canada (543972-19 and 366077487). The first author was sponsored by the Clifford C.F. Wong Fellowship, r?seau de Recherche en Sant? Buccodentaire et Osseuse and Alpha-Omega Foundation of Canada from McGill University, and the Doctoral fellowship from the Chinese Scholarship Council.
This research was sponsored by the Natural Sciences and Engineering Research Council of Canada (543972-19 and 366077487). The first author was sponsored by the Clifford C.F. Wong Fellowship, réseau de Recherche en Santé Buccodentaire et Osseuse and Alpha-Omega Foundation of Canada from McGill University, and the Doctoral fellowship from the Chinese Scholarship Council.
- Feasibility studies
- Infiltration Anesthesia
- Jet Injections
- Local Drug Delivery
- Pilot Studies
- Randomized Clinical Trial
PubMed: MeSH publication types
- Journal Article