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

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ClinicalTrials.gov Identifier: NCT03629041
Recruitment Status : Completed
First Posted : August 14, 2018
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Innoture Ltd

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.

Condition or disease Intervention/treatment Phase
Topical Anaesthesia Device: Microneedle Patch Device: Patch with no microneedles Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study of the Use of Microneedle Patches to Deliver Topical Lidocaine in the Oral Cavity
Actual Study Start Date : July 31, 2018
Actual Primary Completion Date : August 22, 2018
Actual Study Completion Date : August 22, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment A - Microneedle patch
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
At the first visit participants will have either the buccal or palatal treated. At the second visit the other area will be treated.

Sham Comparator: Treatment B - Patch with no microneedles
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
At the first visit participants will have either the buccal or palatal treated. At the second visit the other area will be treated.




Primary Outcome Measures :
  1. To compare the level of perceived pain using a VAS in healthy participants, when topical 5% lidocaine dental gel is applied to the oral mucosa with a microneedle patch and a patch with no microneedles, prior to infiltration with local anaesthesia. [ Time Frame: Following 3 minutes of application of topical anaesthetic using a patch, the 3 tests will be performed and the pain score recorded immediately after each test. ]
    Pain levels will be recorded using a visual analogue scale (VAS). When responding to the VAS item, subjects are 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 (10). The lower the score the better the outcome.

  2. To compare the level of perceived pain using a verbal pain grading, when topical 5% lidocaine dental gel is applied to the oral mucosa with a microneedle patch and a patch with no microneedles, prior to infiltration with local anaesthesia. [ Time Frame: Following 3 minutes of application of topical anaesthetic using a patch, the 3 tests will be performed and the pain score recorded immediately after each test. ]
    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.


Secondary Outcome Measures :
  1. To compare the number of adverse events in healthy participants when a proprietary topical 5% lidocaine dental gel is applied to the oral mucosa with a microneedle patch and a patch with no microneedles, prior to infiltration with local anaesthesia. [ Time Frame: All adverse events will be recorded from time of first study procedure (at visit 1) until the participant completes the study (at visit 2). Visit 2 should occur two weeks after visit 1 and concludes the study for the participant. ]
    Adverse events will be recorded



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. be aged 18 years and over, of either gender and in good health;
  2. be willing and physically able to carry out all study procedures;
  3. be willing and able to give Informed Consent and provide details of any medical history;
  4. be available for all of the study dates
  5. have a good standard of oral hygiene and gingival health
  6. must have 1 premolar or canine in each quadrant that has no/minimal restorations

Exclusion Criteria:

  1. presence of soft tissue oral pathology;
  2. presence of advanced periodontal disease;
  3. Individuals with any serious health conditions, that would preclude participation, in the professional judgement of the Study Dentist;
  4. individuals with known allergies or sensitivities to local anaesthetics
  5. have participated in another clinical trial in the last 30 days
  6. in the opinion of the investigator unable to comply fully with the trial requirements.
  7. the subject is an employee of the Sponsor or the site conducting the study

Information from the National Library of Medicine

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): NCT03629041


Locations
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United Kingdom
Rhiwbina Dental Surgery
Cardiff, United Kingdom, CF14 6HB
Sponsors and Collaborators
Innoture Ltd
Investigators
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Principal Investigator: Nicola X West Bristol Dental School

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Responsible Party: Innoture Ltd
ClinicalTrials.gov Identifier: NCT03629041     History of Changes
Other Study ID Numbers: Innoture/NW-01
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action