Microneedle Pretreatment as a Strategy to Improve the Effectiveness of Topical Anesthetics Formulations

University of Campinas, Brazil

Status and phase: Completed; Phase 1

Conditions: Oral Cavity Disease

Treatments: Drug: Local anesthetic; Drug: Topical Anesthetic

Study type: Interventional

Funder types: Other

Identifiers

NCT05267938

42926115.3.0000.5418

Details and patient eligibility

About

A randomized, crossover, double-blind, two-sessions clinical trial with 30 male volunteers was performed to access pain of local anesthesia after using a topical anesthetic associated or not with prior application of microneedles to the palatal mucosa region

Full description

A randomized, crossover, double-blind, two-sessions clinical trial with 30 male volunteers was performed by applying a microneedle patch and as a negative control the an identical patch but without microneedles sticking out and after the topical anesthetic was applied for in one session 2 minutes and the other session 5 minutes and the investigators evaluated the pain of needle introduction and the injection of the anesthetic.

The application force of the microneedles was standardized to 10N by an applicator composed of a 5 mL syringe and a spring. Pain and discomfort associated to the procedure was evaluated with a Visual Analogue Scale (VAS), in these two different moments, introduction of the needle and injection of the anesthetic.

Enrollment: 30 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male

Exclusion criteria

• Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders, smokers or alcoholic.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Microneedles

Experimental group

Description:

Microneedles is with 750μm of height in order to prepare the palatal mucosa to receive the topical anesthetic

Treatment:

Drug: Topical Anesthetic

Drug: Local anesthetic

patch flat

Sham Comparator group

Description:

The same device as the microneedles but without microneedles

Treatment:

Drug: Topical Anesthetic

Drug: Local anesthetic