Use of Microneedle patches to deliver dental topical anaesthetic
Research type
Research Study
Full title
A STUDY OF THE USE OF MICRONEEDLE PATCHES TO DELIVER TOPICAL LIDOCAINE IN THE ORAL CAVITY Clinical Investigation Plan Number: Innoture/NW-01
IRAS ID
237186
Contact name
Nicola West
Contact email
Sponsor organisation
Innoture Limited
Clinicaltrials.gov Identifier
IRAS ID 231996, MHRA submission
Duration of Study in the UK
0 years, 6 months, 14 days
Research summary
The aim of this study is 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 microneedle patch compared to a patch with no microneedles. The oral sites chosen for the study are the upper palatal area and the upper anterior buccal sulcus. These sites represent two areas, which from clinical experience, are difficult to provide pain free dental injections even with prior application of topical anaesthetics. Assessments of patient perceived pain will be assessed following the placement of a dental needle into the area treated with topical anaesthetic, applied either with or without a microneedle patch, followed by a full injection of local anaesthetic.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
18/SW/0122
Date of REC Opinion
7 Jul 2018
REC opinion
Further Information Favourable Opinion