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Completed

NCT Number: NCT03855397

Pain and Safety of Microneedles in Oral Cavity

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.

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Key information

Conditions

Oral Cavity Disease Mouth Diseases Stomatognathic Diseases

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Michelle Franz Montan Braga Leite

Piracicaba, São Paulo, 13414903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male

Exclusion criteria

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

Treatment and study plan

Microneedle

Other

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.

Hypodermic needle

Other

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

Other names: positive control

Flat patch

Other

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

Other names: negative control

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Collaborators

  • Texas Tech University

Registry information

Official study title

Pain and Safety of Microneedle Application in the Oral Cavity of Human Volunteers

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 26, 2019
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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