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A Split Mouth Trial to Compare Microneedles vs. Standard Needles in Dental Anaesthetic Delivery

NCT02966067 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2018-01-25

No results posted yet for this study

Summary

The study will be completed as a two part, prospective, single-centre, randomised controlled trial.

Five volunteers (dentists) will be recruited in the first part of the study to evaluate and examine the microneedle device and its use. Based on those qualitative findings (individual interviews and focus group) modifications to the microneedle device will be implemented before part two of the study commences.

Twenty volunteers will be enrolled in the second part of the study. A split mouth design will be used to compare the efficacy of an array of 2x3 pyramidal wet-etch silicone microneedles of 280µm height with a standard 30-gauge short hypodermic needle in the delivery of local dental anaesthetic solution. Quantitative and qualitative measurements of the pain experienced and the depth of anaesthesia achieved will be recorded and compared.

Conditions

  • Dental Pain
  • Anesthesia, Local

Interventions

DEVICE

Microneedle Device (Experimental)

Injection of 1.2ml of a standard local dental anaesthetic solution \[1.2ml of 2% lidocaine and 1:80,000 epinephrine (lidocaine 20 mg/ml, epinephrine 12.5 mμ/ml)\] at a rate of 1 mL/min.

DEVICE

30-gauge Short Hypodermic Needle

Injection of 1.2ml of a standard local dental anaesthetic solution \[1.2ml of 2% lidocaine and 1:80,000 epinephrine (lidocaine 20 mg/ml, epinephrine 12.5 mμ/ml)\] at a rate of 1 mL/min.

Sponsors & Collaborators

  • Tyndall National Institute

    collaborator UNKNOWN

  • University of Dublin, Trinity College

    lead OTHER

Principal Investigators

  • Darius Sagheri · University of Dublin, Trinity College

  • Ciarán P Devine · University of Dublin, Trinity College

  • June H Nunn · University of Dublin, Trinity College

  • Erica Donnelly-Swift · University of Dublin, Trinity College

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2017-12-01
Completion
2017-12-08

Countries

  • Ireland

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 NCT02966067 on ClinicalTrials.gov