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

Oral Cavity Disease Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Mouth Diseases
• Oral Cavity Disease

• NCT number: NCT05267938
• Study type: Interventional
• Source: University of Campinas, Brazil
• Status: Completed
• Phase: Phase 1
• Start date: August 1, 2019
• Completion date: January 30, 2020