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

NCT02966067 | Completed

• 1 other identifier: DDUH2011/09/07
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Microneedles; Dental Anaesthesia

Outcome Measures

Primary Outcomes (1)

• Pain Evaluation

  Discomfort / pain intensity rating will be recorded by using a visual analogue scale (VAS)

  Immediately after injection of the anaesthetic

Secondary Outcomes (5)

• Pain Experience

  Immediately after injection of the anaesthetic

• Electronic Pulp Test

  15 minutes after injection

• Thermal Pulp Test

  10 minutes after injection

• Pin-Prick Test

  2 minute intervals alternating with fine touch test until onset of soft tissue anaesthesia

• Fine Touch Test

  2 minute intervals alternating with pin-prick test until onset of soft tissue anaesthesia

Study Arms (2)

Microneedle Device

EXPERIMENTAL

Local Dental Anaesthetic Solution Delivery System: Microneedle device with an array of 2x3 pyramidal wet-etch silicone microneedles of 280µm height to inject anaesthetic solution.

Device: Microneedle Device (Experimental)

30-gauge Short Hypodermic Needle

ACTIVE COMPARATOR

Local Dental Anaesthetic Solution Delivery System: Standard thirty-gauge short hypodermic needle to inject anaesthetic solution.

Device: 30-gauge Short Hypodermic Needle

Interventions

Microneedle Device (Experimental) DEVICE

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.

Also known as: Local Dental Anaesthetic Solution Delivery System

Microneedle Device

30-gauge Short Hypodermic Needle DEVICE

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.

Also known as: Local Dental Anaesthetic Solution Delivery System

30-gauge Short Hypodermic Needle

Eligibility Criteria

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

You may qualify if:

• Individuals are considered eligible for the study if they are not taking any medications and are deemed competent to complete the McGill pain questionnaire short-form (MPQ-SF) and visual analogue scale (VAS).

You may not qualify if:

• Individuals will be excluded from the study if they suffer from the following conditions:
• Hypersensitivity to anaesthetics of the amide type
• Epilepsy
• Hypertension, impaired cardiac conduction
• Impaired respiratory function
• Impaired hepatic function
• Cerebrovascular insufficiency
• Thyrotoxicosis
• Interventions not permitted during the study include the use of steroids, analgesics or other non-steroidal inflammatory drugs and smoking.

Sponsors & Collaborators

• University of Dublin, Trinity College: lead
• Tyndall National Institute: collaborator

Study Sites (1)

University of Dublin, Trinity College

Dublin, Ireland

Location

MeSH Terms

Conditions

Toothache

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Darius Sagheri

  University of Dublin, Trinity College

  PRINCIPAL INVESTIGATOR

• Ciarán P Devine

  University of Dublin, Trinity College

  PRINCIPAL INVESTIGATOR

• June H Nunn

  University of Dublin, Trinity College

  PRINCIPAL INVESTIGATOR

• Erica Donnelly-Swift

  University of Dublin, Trinity College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Orthodontic Therapy

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 17, 2016
• Study Start: September 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 8, 2017
• Last Updated: January 25, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)