Phase 1
N=16
A Study of the Use of Microneedle Patches to Deliver Topical Lidocaine in the Oral Cavity
Topical Anaesthesia
Bottom Line
View on ClinicalTrials.gov: NCT03629041 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: VAS in Healthy Participants, When Topical 5% Lidocaine Dental Gel Was Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With no Microneedles, Prior to Infiltration With Local Anaesthesia. — 5.1; 12.3; 0.7; 4.0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Microneedle Patch (Device); Patch with no microneedles (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Innoture Ltd
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY VAS in Healthy Participants, When Topical 5% Lidocaine Dental Gel Was Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With no Microneedles, Prior to Infiltration With Local Anaesthesia. |
5.1; 12.3; 0.7; 4.0; 11.9; 18.7 | — |
| PRIMARY Verbal Pain Grading, When Topical 5% Lidocaine Dental Gel is Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With No Microneedle Patch, Prior to Infiltration With Local Anaesthesia. Test 1 |
8; 5; 15; 13; 8; 8 | — |
| PRIMARY Verbal Pain Grading, When Topical 5% Lidocaine Dental Gel Was Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With No Microneedle Patch, Prior to Infiltration With Local Anaesthesia. Test 2 |
8; 3; 14; 11; 5; 9 | — |
| PRIMARY Verbal Pain Grading, When Topical 5% Lidocaine Dental Gel Was Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With No Microneedle Patch, Prior to Infiltration With Local Anaesthesia. Test 3 |
1; 1; 3; 1; 7; 3 | — |
| SECONDARY Adverse Events in Healthy Participants When a Proprietary Topical 5% Lidocaine Dental Gel Was Applied to the Oral Mucosa With a Microneedle Patch and a Patch With no Microneedles, Prior to Infiltration With Local Anaesthesia. |
0; 0; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- be aged 18 years and over, of either gender and in good health;
- be willing and physically able to carry out all study procedures;
- be willing and able to give Informed Consent and provide details of any medical history;
- be available for all of the study dates
- have a good standard of oral hygiene and gingival health
- must have 1 premolar or canine in each quadrant that has no/minimal restorations
Exclusion Criteria
- presence of soft tissue oral pathology;
- presence of advanced periodontal disease;
- Individuals with any serious health conditions, that would preclude participation, in the professional judgement of the Study Dentist;
- individuals with known allergies or sensitivities to local anaesthetics
- have participated in another clinical trial in the last 30 days
- in the opinion of the investigator unable to comply fully with the trial requirements.
- the subject is an employee of the Sponsor or the site conducting the study
Data sourced from ClinicalTrials.gov (NCT03629041). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.