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

A Split Mouth, Randomised Controlled Trial to Compare the Efficacy of an Array of 2x3 Pyramidal Microneedles of 280µm Height Versus a Standard 30-gauge Dental Needle in the Delivery of Local Anaesthetic Solution for Dental Procedures

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local; Dental Pain
• Intervention / Treatment: Device: Microneedle Device (Experimental); Device: 30-gauge Short Hypodermic Needle

Detailed Description

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 in order 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 healthy male volunteers will be invited to participate in the second part of the study. Participants will be randomly assigned to receive a dental anaesthetic solution injection with a microneedle device (Group I) or with a standard thirty-gauge short hypodermic needles (Group II) in the first week of the second part of the study.

Group I: The microneedle device will be applied randomly to the left or right buccal mucosa of the first premolar tooth in the maxilla in order to inject slowly a standard local dental anaesthetic solution.

Group II: A standard thirty-gauge short hypodermic needles will be used for insertion and injection of the same standard local dental anaesthetic solution randomly to the left or right buccal mucosa of the first premolar tooth in the maxilla.

Quantitative and qualitative measurements of the pain experienced and the depth of anaesthesia achieved will be recorded for both groups and compared.

In order to eliminate any carryover effects, a washout period of one week between receiving a second, opposite injection will be applied (i.e. Group I will receive an injection with a standard thirty-gauge short hypodermic needles and Group II an injection with the microneedle device). The buccal mucosa of the first premolar tooth in the untreated, opposite maxilla side will receive an injection with the remaining injection method following the same procedure as described for the first week.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • University of Dublin, Trinity College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

•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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microneedle Device; 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); 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.; Other Names: Local Dental Anaesthetic Solution Delivery System
Active Comparator: 30-gauge Short Hypodermic Needle; Local Dental Anaesthetic Solution Delivery System: Standard thirty-gauge short hypodermic needle to inject anaesthetic solution.	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.; Other Names: Local Dental Anaesthetic Solution Delivery System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Evaluation	Discomfort / pain intensity rating will be recorded by using a visual analogue scale (VAS)	Immediately after injection of the anaesthetic

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Experience	Discomfort / pain experience will be recorded by using the Short-Form McGill Pain Questionnaire	Immediately after injection of the anaesthetic
Electronic Pulp Test	An electric pulp tester will be used to determine onset and duration of pulpal anaesthesia	15 minutes after injection
Thermal Pulp Test	Dental refrigerant spray will be sprayed on a cotton pellet and then applied to determine onset and duration of pulpal anaesthesia	10 minutes after injection
Pin-Prick Test	Sensitivity of the buccal mucosa will be assessed with a spring algesimeter	2 minute intervals alternating with fine touch test until onset of soft tissue anaesthesia
Fine Touch Test	Von Frey hair fibres will be used to evaluate the soft tissue sensitivity to touch	2 minute intervals alternating with pin-prick test until onset of soft tissue anaesthesia

Collaborators and Investigators

• Sponsor: University of Dublin, Trinity College
• Collaborators: Tyndall National Institute
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 8, 2017

Study Registration Dates

• First Submitted: November 4, 2016
• First Submitted That Met QC Criteria: November 14, 2016
• First Posted (Estimate): November 17, 2016

Study Record Updates

• Last Update Posted (Actual): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Microneedles; Dental Anaesthesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Facial Pain; Toothache; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics; Pharmaceutical Solutions
• Other Study ID Numbers: DDUH2011/09/07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No