Pain and Safety of Microneedles in Oral Cavity

Not Applicable

Completed

• Conditions: Oral Cavity Disease

• Registration Number: NCT03855397
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-01-16
• Primary Completion: 2018-05-25
• Study Completion: 2018-12-16
• Status Verified: 2019-01
• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-02-25
• Last Update Submitted: 2019-02-25
• Study First Posted: 2019-02-26
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Healthy male

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Michelle Franz Montan Braga Leite; 🇧🇷 Piracicaba, São Paulo, Brazil