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

NCT03629041 | Completed Phase 1 Results

• 1 other identifier: Innoture/NW-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• 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.

  Pain levels were recorded using a visual analogue scale (VAS). When responding to the VAS item, subjects were required to indicate their level of pain by indicating a position along a continuous line between two end-points of no pain (0) and worst pain imaginable (100). The lower the score the better the outcome. The topical lidocaine was applied either with a microneedle patch or a patch with no microneedles for 3 minutes. Immediately afterwards three tests were performed: Test 1, a short dental needle, mounted on a dental syringe containing a cartridge of 2% lidocaine hydrochloride and 1:80,000 adrenaline, was used to penetrate the oral mucosa at the treated site; test 2, the same needle was inserted through the oral mucosa and down to contact bone; test 3, the same needle was again inserted through the oral mucosa and the cartridge of local anaesthetic was injected into the site.

  Following 3 minutes of application of topical anaesthetic using a patch, the 3 tests were performed and the pain score recorded immediately after each test.

• 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

  Pain levels will be recorded using a Verbal Pain Grading. For the verbal pain grading, subjects are asked to score either zero, mild, moderate or severe. In test 1, a short dental needle, mounted on a dental syringe containing a cartridge of 2% lidocaine hydrochloride and 1:80,000 adrenaline, was used to penetrate the oral mucosa at the treated site.

  Following three minutes of application of topical anaesthetic with a patch, the 3 tests were performed and the pain score recorded immediately after each test.

• 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

  Pain levels were recorded using a Verbal Pain Grading. For the verbal pain grading, subjects were asked to score either zero, mild, moderate or severe. In test 2, the same needle as test 1 was inserted through the oral mucosa and down to contact bone.

  Following three minutes of application of topical anaesthetic with a patch, the 3 tests were performed and the pain score recorded immediately after each test.

• 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

  Pain levels were recorded using a Verbal Pain Grading. For the verbal pain grading, subjects were asked to score either zero, mild, moderate or severe. In test 3, the same needle as test 1 and test 2 was again inserted through the oral mucosa and the cartridge of local anaesthetic was injected into the site.

  Following three minutes of application of topical anaesthetic with a patch, the 3 tests were performed and the pain score recorded immediately after each test.

Secondary Outcomes (1)

• 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.

  Events were collected from the time of informed consent until end of treatment or when an ongoing AE had resolved whichever was latest, unless the PI & the Innoture contact from the clinical investigation plan agreed that no further follow up was needed.

Study Arms (2)

Treatment A - Microneedle patch

EXPERIMENTAL

The application of a 5% topical lidocaine gel to one of the identified areas within the participants mouth using a microneedle patch. The microneedle patch will be applied to the oral mucosa of the identified site for 3 minutes, followed by infiltration with local anaesthetic to one of the identified areas within the participants mouth.

Device: Microneedle Patch

Treatment B - Patch with no microneedles

SHAM COMPARATOR

The application of a 5% topical lidocaine gel to one of the identified sites within the participants mouth using a patch with no microneedles. The patch with no microneedles will be applied to the oral mucosa of the identified site for 3 minutes, followed by infiltration with local anaesthetic to one of the identified areas within the participants mouth.

Device: Patch with no microneedles

Interventions

Microneedle Patch DEVICE

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

Treatment A - Microneedle patch

Patch with no microneedles DEVICE

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

Treatment B - Patch with no microneedles

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Innoture Ltd: lead

Study Sites (1)

Rhiwbina Dental Surgery

Cardiff, CF14 6HB, United Kingdom

Location

MeSH Terms

Interventions

Transdermal Patch

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

• Title: Jemma Burridge, Clinical Project Manager
• Organization: Innoture Ltd

jburridge@innoture.co

+44 (0)7799 902476

Study Officials

• Nicola X West

  Bristol Dental School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 14, 2018
• Study Start: July 31, 2018
• Primary Completion: August 22, 2018
• Study Completion: August 22, 2018
• Last Updated: November 14, 2019
• Results First Posted: November 14, 2019

Record last verified: 2019-10

Locations

GB (1)