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Pain and Safety of Microneedles in Oral Cavity

Sponsor
University of Campinas, Brazil (Other)
Overall Status
Completed
CT.gov ID
NCT03855397
Collaborator
Texas Tech University (Other)
30
Enrollment
1
Location
1
Arm
11
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Microneedle
  • Other: Hypodermic needle
  • Other: Flat patch
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
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 :
Jan 16, 2018
Actual Primary Completion Date :
May 25, 2018
Actual Study Completion Date :
Dec 16, 2018

Arms and Interventions

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 Names:
  • positive control

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain sensitivity assessment by Visual Analogue Scale after microneedle application in the oral cavity [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 [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 [Right after microneedle application]

      Mucosal perforation after microneedles application was confirmed by applying gentian violet to stain the sites of microneedle insertion

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Healthy male
    Exclusion Criteria:
    • Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders, smokers or alcoholic.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Michelle Franz Montan Braga Leite Piracicaba São Paulo Brazil 13414903

    Sponsors and Collaborators

    • University of Campinas, Brazil
    • Texas Tech University

    Investigators

    • Principal Investigator: Michelle Leite, PhD, University of Campinas, Brazil
    • Principal Investigator: Harvinder S Gill, PhD, Texas Tech University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michelle Franz Montan Braga Leite, DDS, MSc, PhD, Principal Investigator, University of Campinas, Brazil
    ClinicalTrials.gov Identifier:
    NCT03855397
    Other Study ID Numbers:
    • CAAE: 42926115.3.0000.5418
    First Posted:
    Feb 26, 2019
    Last Update Posted:
    Feb 26, 2019
    Last Verified:
    Jan 1, 2019
    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, Principal Investigator, University of Campinas, Brazil
    Microneedles
    Buccal mucosa
    Transbuccal administration
    Additional relevant MeSH terms:
    Mouth Diseases

    Study Results

    No Results Posted as of Feb 26, 2019