Needle-free injection: Dental infiltration anesthesia

Qiman Gao; Geoffroy Noël; Zovinar Der Khatchadourian; Doaa Taqi; Mohammad Abusamak; Anna Henley; Karim Menassa; Ana Velly; Elham Emami; Luc Mongeau; Faleh Tamimi

doi:10.1016/j.ijpharm.2021.120765

Needle-free injection: Dental infiltration anesthesia

Qiman Gao, Geoffroy Noël, Zovinar Der Khatchadourian, Doaa Taqi, Mohammad Abusamak, Anna Henley, Karim Menassa, Ana Velly, Elham Emami, Luc Mongeau, Faleh Tamimi

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3 Scopus citations

Abstract

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)
Article number	120765
Journal	International journal of pharmaceutics
Volume	604
DOIs	https://doi.org/10.1016/j.ijpharm.2021.120765
State	Published - Jul 15 2021
Externally published	Yes

Bibliographical note

Funding 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.

Funding Information:
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.

Publisher Copyright:
© 2021

Keywords

Complications
Feasibility studies
Infiltration Anesthesia
Jet Injections
Local Drug Delivery
Pilot Studies
Randomized Clinical Trial

PubMed: MeSH publication types

Journal Article

Publisher link

10.1016/j.ijpharm.2021.120765

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title = "Needle-free injection: Dental infiltration anesthesia",

abstract = "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.",

keywords = "Complications, Feasibility studies, Infiltration Anesthesia, Jet Injections, Local Drug Delivery, Pilot Studies, Randomized Clinical Trial",

author = "Qiman Gao and Geoffroy No{\"e}l and {Der Khatchadourian}, Zovinar and Doaa Taqi and Mohammad Abusamak and Anna Henley and Karim Menassa and Ana Velly and Elham Emami and Luc Mongeau and Faleh Tamimi",

note = "Funding 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. Funding Information: 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{\'e}seau de Recherche en Sant{\'e} Buccodentaire et Osseuse and Alpha-Omega Foundation of Canada from McGill University, and the Doctoral fellowship from the Chinese Scholarship Council. Publisher Copyright: {\textcopyright} 2021",

year = "2021",

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doi = "10.1016/j.ijpharm.2021.120765",

language = "English (US)",

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AU - Gao, Qiman

AU - Noël, Geoffroy

AU - Der Khatchadourian, Zovinar

AU - Taqi, Doaa

AU - Abusamak, Mohammad

AU - Henley, Anna

AU - Menassa, Karim

AU - Velly, Ana

AU - Emami, Elham

AU - Mongeau, Luc

AU - Tamimi, Faleh

N1 - Funding 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. Funding Information: 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. Publisher Copyright: © 2021

PY - 2021/7/15

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N2 - 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.

AB - 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.

KW - Complications

KW - Feasibility studies

KW - Infiltration Anesthesia

KW - Jet Injections

KW - Local Drug Delivery

KW - Pilot Studies

KW - Randomized Clinical Trial

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ER -

Needle-free injection: Dental infiltration anesthesia

Abstract

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Keywords

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