NCT04493528

Brief Summary

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 22, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 30, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

4.4 years

First QC Date

July 22, 2020

Last Update Submit

September 2, 2021

Conditions

Anesthesia, LocalNeedle Phobia

Keywords

Needle-free injectionDental anesthesiaInfiltrationNerve block

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (7)

  • Baseline pain level

    1 minute before injection

  • Pain level during injection

    10 seconds after the injection

  • Baseline anxiety level

    1 minute before injection

  • Anxiety level during injection

    10 seconds after the injection.

  • Taste preference

    1 minute after the injection

  • +2 more secondary outcomes

Other Outcomes (2)

  • Participant's feedbacks

    20 minutes after all procedures.

  • Barriers

    through study completion, from date of recruitment until the date of last follow-up case complition, an average of 6 month.

Study Arms (8)

Needle Infiltration anesthesia

ACTIVE COMPARATOR

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)

Needle-free infiltration anesthesia

EXPERIMENTAL

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)

Needle mental nerve block

ACTIVE COMPARATOR

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)

Needle-free mental nerve block

EXPERIMENTAL

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)

Needle mandibular nerve block

ACTIVE COMPARATOR

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)

Needle-free mandibular nerve block

EXPERIMENTAL

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)

Needle infraorbital nerve block

ACTIVE COMPARATOR

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)

Needle-free infraorbital nerve block

EXPERIMENTAL

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)

Interventions

Meso-Jet, 2% lidocaine(xylocaine)COMBINATION_PRODUCT

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.

Also known as: needle-free device, jet injector, NFLJI (Needle-free liquid jet injection system)
Needle-free infiltration anesthesiaNeedle-free infraorbital nerve blockNeedle-free mandibular nerve blockNeedle-free mental nerve block
Needle,2% lidocaine(xylocaine)COMBINATION_PRODUCT

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.

Needle Infiltration anesthesiaNeedle infraorbital nerve blockNeedle mandibular nerve blockNeedle mental nerve block

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University Faculty of Dentistry

Montreal, Quebec, H2X1G1, Canada

Location

Study Officials

  • Faleh Tamimi, Ph.D.

    McGill University Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Each participant receive two anesthesia methods randomly. Total 8 arms, 4 groups, each group will recruit 6 participants. Incase of drop out, a total of 30 participant will be enrolled.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized split-mouth cross-over clinical trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Accociate Dean

Study Record Dates

First Submitted

July 22, 2020

First Posted

July 30, 2020

Study Start

July 18, 2019

Primary Completion

December 15, 2023

Study Completion

December 30, 2023

Last Updated

September 5, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)