Pain and Safety of Microneedles in Oral Cavity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-16

Study Completion Date

2018-12-16

Brief Summary

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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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Detailed Description

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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.

Conditions

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Oral Cavity Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Microneedle

Intervention Type 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

Intervention Type OTHER

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

Flat patch

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Hypodermic needle

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

Intervention Type OTHER

Flat patch

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

Intervention Type OTHER

Other Intervention Names

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positive control negative control

Eligibility Criteria

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Inclusion Criteria

\- Healthy male

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes