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

Primary Purpose

Oral Cavity Disease

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Topical Anesthetic
Local anesthetic
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Oral Cavity Disease focused on measuring Microneedles, Oral Cavity, Transbuccal administration

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

- Healthy male

Exclusion Criteria:

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

Sites / Locations

  • Michelle Franz Montan Braga Leite

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Microneedles

patch flat

Arm Description

Microneedles is with 750μm of height in order to prepare the palatal mucosa to receive the topical anesthetic

The same device as the microneedles but without microneedles

Outcomes

Primary Outcome Measures

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,

Secondary Outcome Measures

Full Information

First Posted
February 23, 2022
Last Updated
March 4, 2022
Sponsor
University of Campinas, Brazil
Collaborators
Texas Tech University
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1. Study Identification

Unique Protocol Identification Number
NCT05267938
Brief Title
Microneedle Pretreatment as a Strategy to Improve the Effectiveness of Topical Anesthetics Formulations
Official Title
Microneedle Pretreatment as a Strategy to Improve the Effectiveness of Topical Anesthetics Formulations
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil
Collaborators
Texas Tech University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cavity Disease
Keywords
Microneedles, Oral Cavity, Transbuccal administration

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Microneedles
Arm Type
Experimental
Arm Description
Microneedles is with 750μm of height in order to prepare the palatal mucosa to receive the topical anesthetic
Arm Title
patch flat
Arm Type
Sham Comparator
Arm Description
The same device as the microneedles but without microneedles
Intervention Type
Drug
Intervention Name(s)
Topical Anesthetic
Other Intervention Name(s)
treatment
Intervention Description
The topical anesthetic used in this experimental is EMLA® after the pre-treatment of the palatal mucosa
Intervention Type
Drug
Intervention Name(s)
Local anesthetic
Other Intervention Name(s)
Lidocaine with epinephrine
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain sensitivity assessment by Visual Analogue Scale after the after puncture and injection of local anesthetic
Description
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,
Time Frame
2 minutes or 5 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Healthy male Exclusion Criteria: Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders, smokers or alcoholic.
Facility Information:
Facility Name
Michelle Franz Montan Braga Leite
City
Piracicaba
State/Province
São Paulo
ZIP/Postal Code
13414903
Country
Brazil

12. IPD Sharing Statement

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

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