Clinical trial NCT02966067: A Split Mouth Trial to Compare Microneedles vs. Standard Needles in Dental Anaesthetic Delivery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Pain
Anesthesia, Local
Keywords: Microneedles
Dental Anaesthesia
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: Tyndall National Institute
First posted: 2016-11-17
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Pain Evaluation
timeFrame: Immediately after injection of the anaesthetic
Secondary outcomes:
measure: Pain Experience
timeFrame: Immediately after injection of the anaesthetic
measure: Electronic Pulp Test
timeFrame: 15 minutes after injection
measure: Thermal Pulp Test
timeFrame: 10 minutes after injection
measure: Pin-Prick Test
timeFrame: 2 minute intervals alternating with fine touch test until onset of soft tissue anaesthesia
measure: Fine Touch Test
timeFrame: 2 minute intervals alternating with pin-prick test until onset of soft tissue anaesthesia
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: University of Dublin, Trinity College
Study officials:
affiliation: University of Dublin, Trinity College
name: Darius Sagheri
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Dublin, Trinity College
name: Ciarán P Devine
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Dublin, Trinity College
name: June H Nunn
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Dublin, Trinity College
name: Erica Donnelly-Swift
role: PRINCIPAL_INVESTIGATOR
References: