Needle-free Dental Anesthesia

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04493528
• Other study ID #: A09-M36-18A
• Status: Suspended
• Phase: N/A
• Start date: July 18, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: September 2021
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: December 30, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Local
• Needle Phobia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	McGill University Faculty of Dentistry	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	MEDICAL INTERNATIONAL TECHNOLOGIES (MIT CANADA) INC.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participant's feedbacks	Reord participants's feedbacks about the whole trial, such as: overall feelings, preferences,complains.	20 minutes after all procedures.
Other	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.
Primary	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.
Primary	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.
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	Incidence of adverse effect [safety]	Incidence of adverse effect immediately after aneshesia injection, such as tissue damage, bleeding, hematoma.	10 seconds after injection.
Secondary	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