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

March 4, 2022 updated by: Michelle Franz Montan Braga Leite, DDS, MSc, PhD, University of Campinas, Brazil
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Piracicaba, São Paulo, Brazil, 13414903
        • Michelle Franz Montan Braga Leite

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Microneedles
Microneedles is with 750μm of height in order to prepare the palatal mucosa to receive the topical anesthetic
Drug: Topical Anesthetic
The topical anesthetic used in this experimental is EMLA® after the pre-treatment of the palatal mucosa
Other Names:
  • treatment
Drug: 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
Other Names:
  • Lidocaine with epinephrine
Sham Comparator: patch flat
The same device as the microneedles but without microneedles
Drug: Topical Anesthetic
The topical anesthetic used in this experimental is EMLA® after the pre-treatment of the palatal mucosa
Other Names:
  • treatment
Drug: 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
Other Names:
  • Lidocaine with epinephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain sensitivity assessment by Visual Analogue Scale after the after puncture and injection of local anesthetic
Time Frame: 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,
2 minutes or 5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Collaborators

Texas Tech University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

October 30, 2019

Study Completion (Actual)

January 30, 2020

Study Registration Dates

First Submitted

February 23, 2022

First Submitted That Met QC Criteria

February 23, 2022

First Posted (Actual)

March 7, 2022

Study Record Updates

Last Update Posted (Actual)

March 21, 2022

Last Update Submitted That Met QC Criteria

March 4, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 42926115.3.0000.5418

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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