MedTrace Logo

Pain and Safety of Microneedles in Oral Cavity

NCT03855397 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-02-26

No results posted yet for this study

Summary

A randomized, crossover, double-blind, placebo-controlled, one-session clinical trial with 30 male volunteers was performed to access pain and safety of microneedle topical application in different regions of the oral cavity.

Conditions

  • Oral Cavity Disease

Interventions

OTHER

Microneedle

A microneedle patch (no drug) was applied in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa to access pain, discomfort and safety.

OTHER

Hypodermic needle

30 gauge hypodermic needle was inserted in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa.

OTHER

Flat patch

A flat patch was applied in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa.

Sponsors & Collaborators

  • Texas Tech University

    collaborator OTHER

  • University of Campinas, Brazil

    lead OTHER

Principal Investigators

  • Michelle Leite, PhD · University of Campinas, Brazil

  • Harvinder S Gill, PhD · Texas Tech University

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-16
Primary Completion
2018-05-25
Completion
2018-12-16

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03855397 on ClinicalTrials.gov