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A Study of the Use of Microneedle Patches to Deliver Topical Lidocaine in the Oral Cavity

NCT03629041 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-11-14

Study results available
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Summary

To look at the effect on patient perceived pain resulting from infiltration injection with local anaesthetic in a dental syringe with prior application of topical anaesthetic to the oral mucosa on a microneedle patch compared to a patch with no microneedles. To look at the safety of the patches when applied to the oral mucosa.

Conditions

  • Topical Anaesthesia

Interventions

DEVICE

Microneedle Patch

At the first visit participants will have either the buccal or palatal treated. At the second visit the other area will be treated.

DEVICE

Patch with no microneedles

At the first visit participants will have either the buccal or palatal treated. At the second visit the other area will be treated.

Sponsors & Collaborators

  • Innoture Ltd

    lead INDUSTRY

Principal Investigators

  • Nicola X West · Bristol Dental School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2018-08-22
Completion
2018-08-22

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03629041 on ClinicalTrials.gov