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

Not Applicable

Completed

• Conditions: Dental Pain; Anesthesia, Local
• Interventions: Device: Microneedle Device (Experimental); Device: 30-gauge Short Hypodermic Needle

• Registration Number: NCT02966067
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-11-04
• Study First Submitted QC: 2016-11-14
• Study First Posted: 2016-11-17
• Study Start: 2017-09-01
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-08
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 5

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).

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Microneedle Device	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.
30-gauge Short Hypodermic Needle	30-gauge Short Hypodermic Needle	Local Dental Anaesthetic Solution Delivery System: Standard thirty-gauge short hypodermic needle to inject anaesthetic solution.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pin-Prick Test	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
Pain Experience	Immediately after injection of the anaesthetic	Discomfort / pain experience will be recorded by using the Short-Form McGill Pain Questionnaire
Electronic Pulp Test	15 minutes after injection	An electric pulp tester will be used to determine onset and duration of pulpal anaesthesia
Thermal Pulp Test	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
Fine Touch Test	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

Trial Locations

Locations (1)

University of Dublin, Trinity College; 🇮🇪 Dublin, Ireland