Needle-free Dental Anesthesia

Needle-free Dental Anesthesia: a Pilot Split-mouth Cross-over Randomized Clinical Trial.

Many patients experience pain and anxiety from traditional needle anesthesia and may avoid necessary dental treatments. The needle-free liquid jet injection(NFLJI) could solve these problems. NFLJI delivers drug solutions by creating a micro-thin pressure liquid jet to penetrate the skin and disperse in the soft tissue. It has many advantages like eliminating injection pain, needle phobia and needle disposal. However, anesthesia techniques in dentistry were all developed for needle injection, and they are not very effective for NFLJI. Moreover, clinical trials of dental anesthesia using NFLJI have shown inconsistent efficacy.

In this study, we aim to compare the clinical efficacy between NFLJI and needle dental anesthesia in pilot split-mouth cross-over randomized clinical trials, assess the feasibility to conduct such trial on a larger scale.

Participants will be assigned to one of the following four groups: 1. Infiltration on a maxillary lateral incisor,2. Inferior alveolar nerve block, 3.Mental nerve block, 4. Infraorbital nerve block. Each participant will receive one injection with a needle and another one with NFLJI randomly at the same appointment. A washout period of 1 hour between two procedures for participants' to forget the previous experience. Needle injection will be performed according to clinical standards. NFLJI will be performed according to a guideline developed in our research group. Participants will stay in the clinic until the anesthesia effect disappear and be followed for one week.

The primary outcome is the efficacy and effect of two anesthesia interventions. The secondary outcome is the pain and anxiety visual analogue scale before and during injection, taste preference, and complications. Additionally, patients' overall feelings for two interventions as well as any barriers to conducting such a trial will be recorded.

Study Overview

• Status: Suspended
• Conditions: Anesthesia, Local; Needle Phobia
• Intervention / Treatment: Combination product: Needle,2% lidocaine(xylocaine); Combination product: Meso-Jet, 2% lidocaine(xylocaine)

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X1G1
      • McGill University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age between 18-35 years-old
• fluent in English
• cooperate

Exclusion Criteria:

• has a history of chronic pain,
• has a systematic disease,
• has root canal therapy at the upper lateral incisor/lower posterior teeth region.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Needle Infiltration anesthesia; Patients received one needle injection of infiltration anesthesia at left or right upper lateral incisors using 1 ml 2% lidocaine with 1:50,000 epinephrine (xylocaine).	Combination product: Needle,2% lidocaine(xylocaine); Performing local dental anesthesia using syringe and needles, same as regular clinical practice. Anesthestic agent: 2% lidocaine with 1:100,000 epinephrine,dose: 0.3-2ml.
EXPERIMENTAL: Needle-free infiltration anesthesia; Patients received one NFLJI (needle-free liquid jet injection) of infiltration anesthesia at left or right upper lateral incisors using 1 ml 2% lidocaine with 1:50,000 epinephrine (xylocaine).	Combination product: Meso-Jet, 2% lidocaine(xylocaine); Performing local dental anesthesia using needle-free liquid jet injection with different parameters (pressure, volume, injection technique). Anesthetic agent: 2% lidocaine with 1:100,000 epinephrine, dose: 0.3-2ml.; Other Names: needle-free device; jet injector; NFLJI (Needle-free liquid jet injection system)
ACTIVE_COMPARATOR: Needle mental nerve block; Patients received one needle injection of mental nerve block at left or right lower premolar region using 1 ml 2% lidocaine with 1:50,000 epinephrine (xylocaine).	Combination product: Needle,2% lidocaine(xylocaine); Performing local dental anesthesia using syringe and needles, same as regular clinical practice. Anesthestic agent: 2% lidocaine with 1:100,000 epinephrine,dose: 0.3-2ml.
EXPERIMENTAL: Needle-free mental nerve block; Patients received one NFLJI (needle-free liquid jet injection) of mental nerve block at left or right lower premolar region using 1 ml 2% lidocaine with 1:50,000 epinephrine (xylocaine).	Combination product: Meso-Jet, 2% lidocaine(xylocaine); Performing local dental anesthesia using needle-free liquid jet injection with different parameters (pressure, volume, injection technique). Anesthetic agent: 2% lidocaine with 1:100,000 epinephrine, dose: 0.3-2ml.; Other Names: needle-free device; jet injector; NFLJI (Needle-free liquid jet injection system)
ACTIVE_COMPARATOR: Needle mandibular nerve block; Patients received one needle injection of mandibular nerve block at left or right mandibular foramen using 2 ml 2% lidocaine with 1:50,000 epinephrine (xylocaine).	Combination product: Needle,2% lidocaine(xylocaine); Performing local dental anesthesia using syringe and needles, same as regular clinical practice. Anesthestic agent: 2% lidocaine with 1:100,000 epinephrine,dose: 0.3-2ml.
EXPERIMENTAL: Needle-free mandibular nerve block; Patients received one NFLJI (needle-free liquid jet injection) of mandibular nerve block at left or right mandibular foramen using 2 ml 2% lidocaine with 1:50,000 epinephrine (xylocaine).	Combination product: Meso-Jet, 2% lidocaine(xylocaine); Performing local dental anesthesia using needle-free liquid jet injection with different parameters (pressure, volume, injection technique). Anesthetic agent: 2% lidocaine with 1:100,000 epinephrine, dose: 0.3-2ml.; Other Names: needle-free device; jet injector; NFLJI (Needle-free liquid jet injection system)
ACTIVE_COMPARATOR: Needle infraorbital nerve block; Patients received one needle injection of infraorbital nerve block at left or right canine fossa using 1 ml 2% lidocaine with 1:50,000 epinephrine (xylocaine).	Combination product: Needle,2% lidocaine(xylocaine); Performing local dental anesthesia using syringe and needles, same as regular clinical practice. Anesthestic agent: 2% lidocaine with 1:100,000 epinephrine,dose: 0.3-2ml.
EXPERIMENTAL: Needle-free infraorbital nerve block; Patients received one NFLJI (needle-free liquid jet injection) of infraorbital nerve block at left or right canine fossa using 1 ml 2% lidocaine with 1:50,000 epinephrine (xylocaine).	Combination product: Meso-Jet, 2% lidocaine(xylocaine); Performing local dental anesthesia using needle-free liquid jet injection with different parameters (pressure, volume, injection technique). Anesthetic agent: 2% lidocaine with 1:100,000 epinephrine, dose: 0.3-2ml.; Other Names: needle-free device; jet injector; NFLJI (Needle-free liquid jet injection system)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental pulp anesthesia	Dental pulp anesthesia result is measured by an electric pulp test(EPT), successful anesthesia for dental pulp exhibits an EPT at 80.	10 minutes after injection.
Efficacy of dental pulp anesthesia	The number of sucessful dental pulp anesthesia cases over total number of participants in the group.	10 minutes after injection.
Time to initiation of anesthesia	Time to initiation of anesthesia feeling, measured by a simple pinch test using a periodontal probe	1 minute after injection
Time to termination of anesthesia	Time to termination of anesthesia feeling, measured by a simple pinch test using a periodontal probe	3 hours after injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline pain level	Participants' pain level before receiving the needle or needle-free injection, measured by standard visual analog scale for pain. From 0 to 10, 0 stands for "no pain", 10 stands for "worst pain". Higher score means a worse outcome.	1 minute before injection
Pain level during injection	Participants' pain level when receiving the needle or needle-free injection, measured by standard visual analog scale for pain. From 0 to 10, 0 stands for "no pain", 10 stands for "worst pain". Higher score means a worse outcome.	10 seconds after the injection
Baseline anxiety level	Participants' anxiety level before receiving the needle or needle-free injection, measured by visual analogue scale for anxiety. From 0 to 10, 0 stands for ""Not at all Anxious", 10 stands for "Extremely Anxious". Higher score means a worse outcome.	1 minute before injection
Anxiety level during injection	Participants' anxiety level when receiving the needle or needle-free injection, measured by visual analogue scale for anxiety.From 0 to 10, 0 stands for ""Not at all Anxious", 10 stands for "Extremely Anxious". Higher score means a worse outcome.	10 seconds after the injection.
Taste preference	Participants' taste preference after needle or needle-free injection, measured by 9-point hedonic scale for measuring food acceptability. From 1 to 9, 1 stands for "dislike extremely", 5 stands for "neither like or dislike", 9 stands for "like extremely". Higher score means a better outcome.	1 minute after the injection
Incidence of adverse effect [safety]	Incidence of adverse effect immediately after aneshesia injection, such as tissue damage, bleeding, hematoma.	10 seconds after injection.
Incidence of adverse effect during follow-up period[safety]	Incidence of adverse effect after aneshesia procedure during follow-up period, such as: ulcer, hematoma, discomfort, abnormal feeling, nerve damage.	up to 7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant's feedbacks	Reord participants's feedbacks about the whole trial, such as: overall feelings, preferences,complains.	20 minutes after all procedures.
Barriers	Record possible barriesrs in recruitment,randomization,operation.	through study completion, from date of recruitment until the date of last follow-up case complition, an average of 6 month.

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: MEDICAL INTERNATIONAL TECHNOLOGIES (MIT CANADA) INC.
• Investigators: Principal Investigator: Faleh Tamimi, Ph.D., McGill University Faculty of Dentistry

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 18, 2019
• Primary Completion (ANTICIPATED): December 15, 2023
• Study Completion (ANTICIPATED): December 30, 2023

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (ACTUAL): July 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Dental anesthesia; Nerve block; Infiltration; Needle-free injection
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: A09-M36-18A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No