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

NCT05267938 | Completed Phase 1 DMC

• 1 other identifier: 42926115.3.0000.5418
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Oral Cavity Disease

Keywords

Microneedles; Oral Cavity; Transbuccal administration

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Microneedles

EXPERIMENTAL

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

Drug: Topical Anesthetic; Drug: Local anesthetic

patch flat

SHAM COMPARATOR

The same device as the microneedles but without microneedles

Drug: Topical Anesthetic; Drug: Local anesthetic

Interventions

Topical Anesthetic DRUG

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

Also known as: treatment

Microneedles; patch flat

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

Also known as: Lidocaine with epinephrine

Microneedles; patch flat

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Healthy male

You may not qualify if:

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

Sponsors & Collaborators

• University of Campinas, Brazil: lead
• Texas Tech University: collaborator

Study Sites (1)

Michelle Franz Montan Braga Leite

Piracicaba, São Paulo, 13414903, Brazil

Location

MeSH Terms

Conditions

Mouth Diseases

Interventions

Anesthetics, Local; Therapeutics; Lidocaine; Epinephrine

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 7, 2022
• Study Start: August 1, 2019
• Primary Completion: October 30, 2019
• Study Completion: January 30, 2020
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

BR (1)