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

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.

Inclusion Criteria:

- Healthy male

Exclusion Criteria:

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

Every volunteers has received bilateral pre-treatment with microneedles or the negative control in the palatal mucosa, in both sessions, which each session was 2 minutes of topical anesthetic or 5 minutes.