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

Phase 1

Completed

• Conditions: Oral Cavity Disease
• Interventions: Drug: Topical Anesthetic; Drug: Local anesthetic

• Registration Number: NCT05267938
• Lead Sponsor: University of Campinas, Brazil

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2019-08-01
• Primary Completion: 2019-10-30
• Study Completion: 2020-01-30
• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-02-23
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-04
• Study First Posted: 2022-03-07
• Last Update Posted: 2022-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Healthy male

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Microneedles	Local anesthetic	Microneedles is with 750μm of height in order to prepare the palatal mucosa to receive the topical anesthetic
patch flat	Local anesthetic	The same device as the microneedles but without microneedles
patch flat	Topical Anesthetic	The same device as the microneedles but without microneedles
Microneedles	Topical Anesthetic	Microneedles is with 750μm of height in order to prepare the palatal mucosa to receive the topical anesthetic

Primary Outcome Measures

Name	Time	Method
Pain sensitivity assessment by Visual Analogue Scale after the after puncture and injection of local anesthetic	2 minutes or 5 minutes	Microneedles or the negative control were used to prepare the palatal mucosa to receive the topical anesthetic, followed by the insertion of the needle and injection of the local anesthetic, evaluating whether the microneedles improve the effectiveness of the topical agent with a Visual Analogic Scale. The blind investigator, evaluated the values with a rule, the left far end mean 0, for no pain at all and the right far end mean 100 for maximum pain. Therefore, a higher score means a worse outcome,

Trial Locations

Locations (1)

Michelle Franz Montan Braga Leite; 🇧🇷 Piracicaba, São Paulo, Brazil