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

NCT ID: NCT02966067

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2017-12-08

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.

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.

Conditions

Dental Pain; Anesthesia, Local

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Microneedle Device (Experimental)

Intervention Type: 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.

30-gauge Short Hypodermic Needle

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

Group Type: ACTIVE_COMPARATOR

30-gauge Short Hypodermic Needle

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Local Dental Anaesthetic Solution Delivery System; Local Dental Anaesthetic Solution Delivery System

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Tyndall National Institute

UNKNOWN

Sponsor Role: collaborator

University of Dublin, Trinity College

OTHER

Sponsor Role: lead

Responsible Party

Darius Sagheri

Director of Orthodontic Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Darius Sagheri

Role: PRINCIPAL_INVESTIGATOR

University of Dublin, Trinity College

Ciarán P Devine

Role: PRINCIPAL_INVESTIGATOR

University of Dublin, Trinity College

June H Nunn

Role: PRINCIPAL_INVESTIGATOR

University of Dublin, Trinity College

Erica Donnelly-Swift

Role: PRINCIPAL_INVESTIGATOR

University of Dublin, Trinity College

Locations

University of Dublin, Trinity College

Dublin, , Ireland

Countries

Ireland

Other Identifiers

DDUH2011/09/07

Identifier Type: -

Identifier Source: org_study_id