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Completed

NCT Number: NCT05267938

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

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

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Key information

Conditions

Oral Cavity Disease Mouth Diseases Stomatognathic Diseases

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Michelle Franz Montan Braga Leite

Piracicaba, São Paulo, 13414903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male

Exclusion criteria

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

Treatment and study plan

Topical anesthetic

Drug

The topical anesthetic used in this experimental is EMLA® after the pre-treatment of the palatal mucosa

Other names: treatment

Local anesthetic

Drug

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

Primary outcomes

  1. 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,

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Collaborators

  • Texas Tech University

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Mar 7, 2022
Registry last updated
Mar 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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