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

<p dir="ltr">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 c...

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محفوظ في:
التفاصيل البيبلوغرافية
المؤلف الرئيسي: Qiman Gao (12107281) (author)
مؤلفون آخرون: Anna Henley (12107284) (author), Geoffroy Noël (355057) (author), Zovinar Der Khatchadourian (12107287) (author), Doaa Taqi (9689295) (author), Mohammad Abusamak (10712848) (author), Zixin He (12107278) (author), Swen Grœn (17191330) (author), Rani Taher (17191333) (author), Karim Menassa (17191336) (author), Ana Velly (7307576) (author), Elham Emami (4007807) (author), Luc Mongeau (11189809) (author), Faleh Tamimi (2867255) (author)
منشور في: 2021
الموضوعات:
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author Qiman Gao (12107281)
author2 Anna Henley (12107284)
Geoffroy Noël (355057)
Zovinar Der Khatchadourian (12107287)
Doaa Taqi (9689295)
Mohammad Abusamak (10712848)
Zixin He (12107278)
Swen Grœn (17191330)
Rani Taher (17191333)
Karim Menassa (17191336)
Ana Velly (7307576)
Elham Emami (4007807)
Luc Mongeau (11189809)
Faleh Tamimi (2867255)
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author_facet Qiman Gao (12107281)
Anna Henley (12107284)
Geoffroy Noël (355057)
Zovinar Der Khatchadourian (12107287)
Doaa Taqi (9689295)
Mohammad Abusamak (10712848)
Zixin He (12107278)
Swen Grœn (17191330)
Rani Taher (17191333)
Karim Menassa (17191336)
Ana Velly (7307576)
Elham Emami (4007807)
Luc Mongeau (11189809)
Faleh Tamimi (2867255)
author_role author
dc.creator.none.fl_str_mv Qiman Gao (12107281)
Anna Henley (12107284)
Geoffroy Noël (355057)
Zovinar Der Khatchadourian (12107287)
Doaa Taqi (9689295)
Mohammad Abusamak (10712848)
Zixin He (12107278)
Swen Grœn (17191330)
Rani Taher (17191333)
Karim Menassa (17191336)
Ana Velly (7307576)
Elham Emami (4007807)
Luc Mongeau (11189809)
Faleh Tamimi (2867255)
dc.date.none.fl_str_mv 2021-11-20T00:00:00Z
dc.identifier.none.fl_str_mv 10.1016/j.ijpharm.2021.121197
dc.relation.none.fl_str_mv https://figshare.com/articles/journal_contribution/Needle-free_Mental_Incisive_Nerve_Block_In_vitro_Cadaveric_and_Pilot_Clinical_Studies/24339472
dc.rights.none.fl_str_mv CC BY 4.0
info:eu-repo/semantics/openAccess
dc.subject.none.fl_str_mv Biomedical and clinical sciences
Pharmacology and pharmaceutical sciences
Dental anesthesia
Mental nerve
Jet injections
Pilot studies
Feasibility studies
Randomized controlled trial
Paresthesia
dc.title.none.fl_str_mv Needle-free Mental Incisive Nerve Block: In vitro, Cadaveric, and Pilot Clinical Studies
dc.type.none.fl_str_mv Text
Journal contribution
info:eu-repo/semantics/publishedVersion
text
contribution to journal
description <p dir="ltr">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.</p><h2>Other Information</h2><p dir="ltr">Published in: International Journal of Pharmaceutics<br>License: <a href="http://creativecommons.org/licenses/by/4.0/" target="_blank">http://creativecommons.org/licenses/by/4.0/</a><br>See article on publisher's website: <a href="https://dx.doi.org/10.1016/j.ijpharm.2021.121197" target="_blank">https://dx.doi.org/10.1016/j.ijpharm.2021.121197</a></p>
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identifier_str_mv 10.1016/j.ijpharm.2021.121197
network_acronym_str Manara2
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oai_identifier_str oai:figshare.com:article/24339472
publishDate 2021
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spelling Needle-free Mental Incisive Nerve Block: In vitro, Cadaveric, and Pilot Clinical StudiesQiman Gao (12107281)Anna Henley (12107284)Geoffroy Noël (355057)Zovinar Der Khatchadourian (12107287)Doaa Taqi (9689295)Mohammad Abusamak (10712848)Zixin He (12107278)Swen Grœn (17191330)Rani Taher (17191333)Karim Menassa (17191336)Ana Velly (7307576)Elham Emami (4007807)Luc Mongeau (11189809)Faleh Tamimi (2867255)Biomedical and clinical sciencesPharmacology and pharmaceutical sciencesDental anesthesiaMental nerveJet injectionsPilot studiesFeasibility studiesRandomized controlled trialParesthesia<p dir="ltr">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.</p><h2>Other Information</h2><p dir="ltr">Published in: International Journal of Pharmaceutics<br>License: <a href="http://creativecommons.org/licenses/by/4.0/" target="_blank">http://creativecommons.org/licenses/by/4.0/</a><br>See article on publisher's website: <a href="https://dx.doi.org/10.1016/j.ijpharm.2021.121197" target="_blank">https://dx.doi.org/10.1016/j.ijpharm.2021.121197</a></p>2021-11-20T00:00:00ZTextJournal contributioninfo:eu-repo/semantics/publishedVersiontextcontribution to journal10.1016/j.ijpharm.2021.121197https://figshare.com/articles/journal_contribution/Needle-free_Mental_Incisive_Nerve_Block_In_vitro_Cadaveric_and_Pilot_Clinical_Studies/24339472CC BY 4.0info:eu-repo/semantics/openAccessoai:figshare.com:article/243394722021-11-20T00:00:00Z
spellingShingle Needle-free Mental Incisive Nerve Block: In vitro, Cadaveric, and Pilot Clinical Studies
Qiman Gao (12107281)
Biomedical and clinical sciences
Pharmacology and pharmaceutical sciences
Dental anesthesia
Mental nerve
Jet injections
Pilot studies
Feasibility studies
Randomized controlled trial
Paresthesia
status_str publishedVersion
title Needle-free Mental Incisive Nerve Block: In vitro, Cadaveric, and Pilot Clinical Studies
title_full Needle-free Mental Incisive Nerve Block: In vitro, Cadaveric, and Pilot Clinical Studies
title_fullStr Needle-free Mental Incisive Nerve Block: In vitro, Cadaveric, and Pilot Clinical Studies
title_full_unstemmed Needle-free Mental Incisive Nerve Block: In vitro, Cadaveric, and Pilot Clinical Studies
title_short Needle-free Mental Incisive Nerve Block: In vitro, Cadaveric, and Pilot Clinical Studies
title_sort Needle-free Mental Incisive Nerve Block: In vitro, Cadaveric, and Pilot Clinical Studies
topic Biomedical and clinical sciences
Pharmacology and pharmaceutical sciences
Dental anesthesia
Mental nerve
Jet injections
Pilot studies
Feasibility studies
Randomized controlled trial
Paresthesia