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Pain and Safety of Microneedles in Oral Cavity

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ClinicalTrials.gov Identifier: NCT03855397
Recruitment Status : Completed
First Posted : February 26, 2019
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
Texas Tech University
Information provided by (Responsible Party):
Michelle Franz Montan Braga Leite, DDS, MSc, PhD, University of Campinas, Brazil

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.

Condition or disease Intervention/treatment Phase
Oral Cavity Disease Other: Microneedle Other: Hypodermic needle Other: Flat patch Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pain and Safety of Microneedle Application in the Oral Cavity of Human Volunteers
Actual Study Start Date : January 16, 2018
Actual Primary Completion Date : May 25, 2018
Actual Study Completion Date : December 16, 2018

Arm Intervention/treatment
Experimental: Microneedles
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
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 Name: positive control

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




Primary Outcome Measures :
  1. Pain sensitivity assessment by Visual Analogue Scale after microneedle application in the oral cavity [ Time Frame: 30 seconds ]
    Pain was evaluated after microneedles, hypodermic needle or negative control topical application application in different oral cavity sites

  2. 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 [ Time Frame: 24 hours ]
    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 :
  1. Confirmation of mucosal perforationin the oral cavity after application of the devices [ Time Frame: Right after microneedle application ]
    Mucosal perforation after microneedles application was confirmed by applying gentian violet to stain the sites of microneedle insertion



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03855397


Locations
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Brazil
Michelle Franz Montan Braga Leite
Piracicaba, São Paulo, Brazil, 13414903
Sponsors and Collaborators
University of Campinas, Brazil
Texas Tech University
Investigators
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Principal Investigator: Michelle Leite, PhD University of Campinas, Brazil
Principal Investigator: Harvinder S Gill, PhD Texas Tech University

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Responsible Party: Michelle Franz Montan Braga Leite, DDS, MSc, PhD, Principal Investigator, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT03855397     History of Changes
Other Study ID Numbers: CAAE: 42926115.3.0000.5418
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michelle Franz Montan Braga Leite, DDS, MSc, PhD, University of Campinas, Brazil:
Microneedles
Buccal mucosa
Transbuccal administration

Additional relevant MeSH terms:
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Mouth Diseases
Stomatognathic Diseases