Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02966067
Recruitment Status : Completed
First Posted : November 17, 2016
Last Update Posted : January 25, 2018
Sponsor:
Collaborator:
Tyndall National Institute
Information provided by (Responsible Party):
Darius Sagheri, University of Dublin, Trinity College

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.


Condition or disease Intervention/treatment Phase
Dental Pain Anesthesia, Local Device: Microneedle Device (Experimental) Device: 30-gauge Short Hypodermic Needle Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : December 8, 2017

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 Name: 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 Name: Local Dental Anaesthetic Solution Delivery System




Primary Outcome Measures :
  1. Pain Evaluation [ Time Frame: Immediately after injection of the anaesthetic ]
    Discomfort / pain intensity rating will be recorded by using a visual analogue scale (VAS)


Secondary Outcome Measures :
  1. Pain Experience [ Time Frame: Immediately after injection of the anaesthetic ]
    Discomfort / pain experience will be recorded by using the Short-Form McGill Pain Questionnaire

  2. Electronic Pulp Test [ Time Frame: 15 minutes after injection ]
    An electric pulp tester will be used to determine onset and duration of pulpal anaesthesia

  3. Thermal Pulp Test [ Time Frame: 10 minutes after injection ]
    Dental refrigerant spray will be sprayed on a cotton pellet and then applied to determine onset and duration of pulpal anaesthesia

  4. Pin-Prick Test [ Time Frame: 2 minute intervals alternating with fine touch test until onset of soft tissue anaesthesia ]
    Sensitivity of the buccal mucosa will be assessed with a spring algesimeter

  5. Fine Touch Test [ Time Frame: 2 minute intervals alternating with pin-prick test until onset of soft tissue anaesthesia ]
    Von Frey hair fibres will be used to evaluate the soft tissue sensitivity to touch



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

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): NCT02966067


Locations
Layout table for location information
Ireland
University of Dublin, Trinity College
Dublin, Ireland
Sponsors and Collaborators
University of Dublin, Trinity College
Tyndall National Institute
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Darius Sagheri, Director of Orthodontic Therapy, University of Dublin, Trinity College
ClinicalTrials.gov Identifier: NCT02966067     History of Changes
Other Study ID Numbers: DDUH2011/09/07
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Darius Sagheri, University of Dublin, Trinity College:
Microneedles
Dental Anaesthesia

Additional relevant MeSH terms:
Layout table for MeSH terms
Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Pharmaceutical Solutions
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs