Pain and Safety of Microneedles in Oral Cavity
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|ClinicalTrials.gov Identifier: NCT03855397|
Recruitment Status : Completed
First Posted : February 26, 2019
Last Update Posted : February 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Oral Cavity Disease||Other: Microneedle Other: Hypodermic needle Other: Flat patch||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pain and Safety of Microneedle Application in the Oral Cavity of Human Volunteers|
|Actual Study Start Date :||January 16, 2018|
|Actual Primary Completion Date :||May 25, 2018|
|Actual Study Completion Date :||December 16, 2018|
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
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.
Other: Hypodermic needle
30 gauge hypodermic needle was inserted in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa.
Other Name: positive control
Other: Flat patch
A flat patch was applied in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa.
Other Name: negative control
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03855397
|Michelle Franz Montan Braga Leite|
|Piracicaba, São Paulo, Brazil, 13414903|
|Principal Investigator:||Michelle Leite, PhD||University of Campinas, Brazil|
|Principal Investigator:||Harvinder S Gill, PhD||Texas Tech University|