Needle-free Dental Anesthesia

McGill University

Status: Suspended

Conditions: Needle Phobia; Anesthesia, Local

Treatments: Combination Product: Needle,2% lidocaine(xylocaine); Combination Product: Meso-Jet, 2% lidocaine(xylocaine)

Study type: Interventional

Funder types: Other

Identifiers

NCT04493528

A09-M36-18A

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 8 patient groups

Needle Infiltration anesthesia

Active Comparator group

Description:

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).

Treatment:

Combination Product: Needle,2% lidocaine(xylocaine)

Needle-free infiltration anesthesia

Experimental group

Description:

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).

Treatment:

Combination Product: Meso-Jet, 2% lidocaine(xylocaine)

Needle mental nerve block

Active Comparator group

Description:

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).

Treatment:

Combination Product: Needle,2% lidocaine(xylocaine)

Needle-free mental nerve block

Experimental group

Description:

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).

Treatment:

Combination Product: Meso-Jet, 2% lidocaine(xylocaine)

Needle mandibular nerve block

Active Comparator group

Description:

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).

Treatment:

Combination Product: Needle,2% lidocaine(xylocaine)

Needle-free mandibular nerve block

Experimental group

Description:

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).

Treatment:

Combination Product: Meso-Jet, 2% lidocaine(xylocaine)

Needle infraorbital nerve block

Active Comparator group

Description:

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).

Treatment:

Combination Product: Needle,2% lidocaine(xylocaine)

Needle-free infraorbital nerve block

Experimental group

Description:

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).

Treatment:

Combination Product: Meso-Jet, 2% lidocaine(xylocaine)