Pain and Safety of Microneedles in Oral Cavity

Oral Cavity Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03855397
• Other study ID #: CAAE: 42926115.3.0000.5418
• Status: Completed
• Phase: N/A
• Start date: January 16, 2018
• Est. completion date: December 16, 2018

Study information

• Verified date: January 2019
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 16, 2018
• Est. primary completion date: May 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Healthy male

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Mouth Diseases
• Oral Cavity Disease

Intervention

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.
• Hypodermic needle
30 gauge hypodermic needle was inserted in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa.
• Flat patch
A flat patch was applied in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa.

Locations

Country	Name	City	State
Brazil	Michelle Franz Montan Braga Leite	Piracicaba	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Campinas, Brazil	Texas Tech University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 seconds
Primary	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	24 hours
Secondary	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	Right after microneedle application