Pain and Safety of Microneedles in Oral Cavity
Keywords
Abstract
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.
Dates
| Last Verified: | 12/31/2018 |
| First Submitted: | 01/28/2019 |
| Estimated Enrollment Submitted: | 02/24/2019 |
| First Posted: | 02/25/2019 |
| Last Update Submitted: | 02/24/2019 |
| Last Update Posted: | 02/25/2019 |
| Actual Study Start Date: | 01/15/2018 |
| Estimated Primary Completion Date: | 05/24/2018 |
| Estimated Study Completion Date: | 12/15/2018 |
Condition or disease
Intervention/treatment
Other: Microneedles
Other: Microneedles
Other: Microneedles
Phase
Arm Groups
| 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: Microneedles 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. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Male |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Healthy male Exclusion Criteria: - Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders, smokers or alcoholic. |
Outcome
Primary Outcome Measures
1. Pain sensitivity assessment by Visual Analogue Scale after microneedle application in the oral cavity [30 seconds]
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]
Secondary Outcome Measures
1. Confirmation of mucosal perforationin the oral cavity after application of the devices [Right after microneedle application]
