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

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

doi:10.1016/j.ijpharm.2021.121197

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

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

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3 Scopus citations

Abstract

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.

Original language	English (US)
Article number	121197
Journal	International journal of pharmaceutics
Volume	609
DOIs	https://doi.org/10.1016/j.ijpharm.2021.121197
State	Published - Nov 20 2021
Externally published	Yes

Bibliographical note

Funding Information:
This research was sponsored by Canada's Natural Sciences and Engineering Research Council (543972-19 and 366077487). Partial support from the National Institutes of Health (NIH) Grant R01 DC0R01DC018577 (Mongeau, PI) is also acknowledged. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The first author is sponsored by the Clifford C.F. Wong Fellowship, réseau de Recherche en Santé Buccodentaire et Osseuse, and Alpha-OmegaFoundation of Canada from McGill University and the Doctoral fellowship from the Chinese Scholarship Council.

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 Nathalie Morin DDS, Rosa Menale DA, Ann Marie Plante DA from Faculty of Dentistry, McGill University for organizing the clinical trials, Dr. Entisar Abdulkader, Dr. Guangyu Bao and Dr. Ammar Alsheghri for the consultation, and Ms. Joan O'Malley for the photo studio. This research was sponsored by Canada's Natural Sciences and Engineering Research Council (543972-19 and 366077487). Partial support from the National Institutes of Health (NIH) Grant R01 DC0R01DC018577 (Mongeau, PI) is also acknowledged. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The first author is sponsored by the Clifford C.F. Wong Fellowship, r?seau de Recherche en Sant? Buccodentaire et Osseuse, and Alpha-OmegaFoundation of Canada from McGill University and the Doctoral fellowship from the Chinese Scholarship Council.

Publisher Copyright:
© 2021 The Authors

Keywords

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

PubMed: MeSH publication types

Journal Article

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10.1016/j.ijpharm.2021.121197

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Gao, Q., Henley, A., Noël, G., Der Khatchadourian, Z., Taqi, D., Abusamak, M., He, Z., Grœn, S., Taher, R., Menassa, K., Velly, A., Emami, E., Mongeau, L., & Tamimi, F. (2021). Needle-free Mental Incisive Nerve Block: In vitro, Cadaveric, and Pilot Clinical Studies. International journal of pharmaceutics, 609, Article 121197. https://doi.org/10.1016/j.ijpharm.2021.121197

@article{f2971a55289948dea2a10c50c59524c3,

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

abstract = "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.",

keywords = "Dental anesthesia, Feasibility studies, Jet injections, Mental nerve, Paresthesia, Pilot studies, Randomized controlled trial",

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

note = "Funding Information: This research was sponsored by Canada's Natural Sciences and Engineering Research Council (543972-19 and 366077487). Partial support from the National Institutes of Health (NIH) Grant R01 DC0R01DC018577 (Mongeau, PI) is also acknowledged. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The first author is sponsored by the Clifford C.F. Wong Fellowship, r{\'e}seau de Recherche en Sant{\'e} Buccodentaire et Osseuse, and Alpha-OmegaFoundation of Canada from McGill University and the Doctoral fellowship from the Chinese Scholarship Council. 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 Nathalie Morin DDS, Rosa Menale DA, Ann Marie Plante DA from Faculty of Dentistry, McGill University for organizing the clinical trials, Dr. Entisar Abdulkader, Dr. Guangyu Bao and Dr. Ammar Alsheghri for the consultation, and Ms. Joan O'Malley for the photo studio. This research was sponsored by Canada's Natural Sciences and Engineering Research Council (543972-19 and 366077487). Partial support from the National Institutes of Health (NIH) Grant R01 DC0R01DC018577 (Mongeau, PI) is also acknowledged. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The first author is sponsored by the Clifford C.F. Wong Fellowship, r?seau de Recherche en Sant? Buccodentaire et Osseuse, and Alpha-OmegaFoundation of Canada from McGill University and the Doctoral fellowship from the Chinese Scholarship Council. Publisher Copyright: {\textcopyright} 2021 The Authors",

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doi = "10.1016/j.ijpharm.2021.121197",

language = "English (US)",

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T1 - Needle-free Mental Incisive Nerve Block

T2 - In vitro, Cadaveric, and Pilot Clinical Studies

AU - Gao, Qiman

AU - Henley, Anna

AU - Noël, Geoffroy

AU - Der Khatchadourian, Zovinar

AU - Taqi, Doaa

AU - Abusamak, Mohammad

AU - He, Zixin

AU - Grœn, Swen

AU - Taher, Rani

AU - Menassa, Karim

AU - Velly, Ana

AU - Emami, Elham

AU - Mongeau, Luc

AU - Tamimi, Faleh

N1 - Funding Information: This research was sponsored by Canada's Natural Sciences and Engineering Research Council (543972-19 and 366077487). Partial support from the National Institutes of Health (NIH) Grant R01 DC0R01DC018577 (Mongeau, PI) is also acknowledged. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The first author is sponsored by the Clifford C.F. Wong Fellowship, réseau de Recherche en Santé Buccodentaire et Osseuse, and Alpha-OmegaFoundation of Canada from McGill University and the Doctoral fellowship from the Chinese Scholarship Council. 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 Nathalie Morin DDS, Rosa Menale DA, Ann Marie Plante DA from Faculty of Dentistry, McGill University for organizing the clinical trials, Dr. Entisar Abdulkader, Dr. Guangyu Bao and Dr. Ammar Alsheghri for the consultation, and Ms. Joan O'Malley for the photo studio. This research was sponsored by Canada's Natural Sciences and Engineering Research Council (543972-19 and 366077487). Partial support from the National Institutes of Health (NIH) Grant R01 DC0R01DC018577 (Mongeau, PI) is also acknowledged. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The first author is sponsored by the Clifford C.F. Wong Fellowship, r?seau de Recherche en Sant? Buccodentaire et Osseuse, and Alpha-OmegaFoundation of Canada from McGill University and the Doctoral fellowship from the Chinese Scholarship Council. Publisher Copyright: © 2021 The Authors

PY - 2021/11/20

Y1 - 2021/11/20

N2 - 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.

AB - 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.

KW - Dental anesthesia

KW - Feasibility studies

KW - Jet injections

KW - Mental nerve

KW - Paresthesia

KW - Pilot studies

KW - Randomized controlled trial

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

Abstract

Bibliographical note

Keywords

PubMed: MeSH publication types

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