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Pain and Safety of Microneedles in Oral Cavity

Primary Purpose

Oral Cavity Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Microneedle
Hypodermic needle
Flat patch
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, Buccal mucosa, 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 Type

Experimental

Arm Label

Microneedles

Arm Description

Application of microneedle patch, 30G hypodermic needle (positive control) and flat patch (negative control) in the lip, buccal, tongue, palatal and gingival mucosa for pain and safety assessment

Outcomes

Primary Outcome Measures

Pain sensitivity assessment by Visual Analogue Scale after microneedle application in the oral cavity
Pain was evaluated after microneedles, hypodermic needle or negative control topical application application in different oral cavity sites
Number of participants with treatment-related adverse events as assessed by visual inspection of ecchymosis, ulceration, redness, swelling or bleeding after microneedles use in the oral cavity
Any sign of ecchymosis, ulceration, redness, swelling or bleeding right after and 24 h later applications of the devices in different oral cavity sites

Secondary Outcome Measures

Confirmation of mucosal perforationin the oral cavity after application of the devices
Mucosal perforation after microneedles application was confirmed by applying gentian violet to stain the sites of microneedle insertion

Full Information

First Posted
January 29, 2019
Last Updated
February 25, 2019
Sponsor
University of Campinas, Brazil
Collaborators
Texas Tech University
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1. Study Identification

Unique Protocol Identification Number
NCT03855397
Brief Title
Pain and Safety of Microneedles in Oral Cavity
Official Title
Pain and Safety of Microneedle Application in the Oral Cavity of Human Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 16, 2018 (Actual)
Primary Completion Date
May 25, 2018 (Actual)
Study Completion Date
December 16, 2018 (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, 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.
Detailed Description
A randomized, crossover, double-blind, placebo-controlled, one-session clinical trial with 30 male volunteers was performed by applying a microneedle patch in the following regions of the oral cavity: lip (inner lower), buccal (cheek: 1 cm behind the month angle), tongue (dorsal surface), hard palate (anterior region), and attached gingiva (between central and lateral upper incisors). A 30 gauge hypodermic needle and an identical patch but without microneedles sticking out, were used as positive and negative controls, respectively. The application force was standardized to 10N by an applicator composed of a 5 mL syringe and a spring. Insertions were performed with a gap of 30 seconds. Pain and discomfort associated to the procedure was evaluated with a Visual Analogue Scale (VAS), by a blinded-dentist. The safety associated to microneedle application was verified immediately after the application (0h) and after the next day (24h). The different application sites were inspected visually for bleeding, ulceration, bruising, redness or swelling.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Microneedles
Arm Type
Experimental
Arm Description
Application of microneedle patch, 30G hypodermic needle (positive control) and flat patch (negative control) in the lip, buccal, tongue, palatal and gingival mucosa for pain and safety assessment
Intervention Type
Other
Intervention Name(s)
Microneedle
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Hypodermic needle
Other Intervention Name(s)
positive control
Intervention Description
30 gauge hypodermic needle was inserted in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa.
Intervention Type
Other
Intervention Name(s)
Flat patch
Other Intervention Name(s)
negative control
Intervention Description
A flat patch was applied in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa.
Primary Outcome Measure Information:
Title
Pain sensitivity assessment by Visual Analogue Scale after microneedle application in the oral cavity
Description
Pain was evaluated after microneedles, hypodermic needle or negative control topical application application in different oral cavity sites
Time Frame
30 seconds
Title
Number of participants with treatment-related adverse events as assessed by visual inspection of ecchymosis, ulceration, redness, swelling or bleeding after microneedles use in the oral cavity
Description
Any sign of ecchymosis, ulceration, redness, swelling or bleeding right after and 24 h later applications of the devices in different oral cavity sites
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Confirmation of mucosal perforationin the oral cavity after application of the devices
Description
Mucosal perforation after microneedles application was confirmed by applying gentian violet to stain the sites of microneedle insertion
Time Frame
Right after microneedle application

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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Leite, PhD
Organizational Affiliation
University of Campinas, Brazil
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Harvinder S Gill, PhD
Organizational Affiliation
Texas Tech University
Official's Role
Principal Investigator
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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Pain and Safety of Microneedles in Oral Cavity

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