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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05267938
• Other study ID #: 42926115.3.0000.5418
• Status: Completed
• Phase: Phase 1
• Start date: August 1, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: March 2022
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 30, 2020
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Healthy male

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Mouth Diseases
• Oral Cavity Disease

Intervention

Drug:
• Topical Anesthetic
The topical anesthetic used in this experimental is EMLA® after the pre-treatment of the palatal mucosa
• Local anesthetic
After the pre-treatment with microneedles and the use of topical anesthetic, the needle and injection of local anesthetic was inserted and pain was evaluated

Locations

Country	Name	City	State
Brazil	Michelle Franz Montan Braga Leite	Piracicaba	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Campinas, Brazil	Texas Tech University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain sensitivity assessment by Visual Analogue Scale after the after puncture and injection of local anesthetic	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,	2 minutes or 5 minutes