Dental PainNCT02966067
A Split Mouth Trial to Compare Microneedles vs. Standard Needles in Dental Anaesthetic Delivery
A study testing Microneedle Device (Experimental) and 30-gauge Short Hypodermic Needle in people with Dental Pain and Anesthesia, Local, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dental Pain, Anesthesia, Local
- What is being tested?
- Microneedle Device (Experimental) and 30-gauge Short Hypodermic Needle
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIreland
- Study dates
- 1 Sep 2017to 8 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- •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).
Who cannot join
- 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
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- Cerebrovascular insufficiency
- Thyrotoxicosis
- Interventions not permitted during the study include the use of steroids, analgesics or other non-steroidal inflammatory drugs and smoking.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Microneedle Device (Experimental), 30-gauge Short Hypodermic Needle
- Keywords
- Microneedles, Dental Anaesthesia
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microneedle Device (Experimental)Device
Also called Local Dental Anaesthetic Solution Delivery System
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 NeedleDevice
Also called Local Dental Anaesthetic Solution Delivery System
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Microneedle Device (Experimental) |
| 30-gauge Short Hypodermic Needle | Active comparator | Local Dental Anaesthetic Solution Delivery System: Standard thirty-gauge short hypodermic needle to inject anaesthetic solution. Receives: Device: 30-gauge Short Hypodermic Needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Evaluation
Discomfort / pain intensity rating will be recorded by using a visual analogue scale (VAS)
Measured: Immediately after injection of the anaesthetic
Secondary outcomes (5)
Pain Experience
Discomfort / pain experience will be recorded by using the Short-Form McGill Pain Questionnaire
Measured: Immediately after injection of the anaesthetic
Electronic Pulp Test
An electric pulp tester will be used to determine onset and duration of pulpal anaesthesia
Measured: 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
Measured: 10 minutes after injection
Pin-Prick Test
Sensitivity of the buccal mucosa will be assessed with a spring algesimeter
Measured: 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
Measured: 2 minute intervals alternating with pin-prick test until onset of soft tissue anaesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study start1 Sep 2017
- Primary completion1 Dec 2017
- Study completion8 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- Tyndall National Institute
- Responsible party
- Principal investigator, Darius Sagheri, University of Dublin, Trinity College
- Investigators
- Darius Sagheri, Principal investigator, University of Dublin, Trinity CollegeCiarán P Devine, Principal investigator, University of Dublin, Trinity CollegeJune H Nunn, Principal investigator, University of Dublin, Trinity CollegeErica Donnelly-Swift, Principal investigator, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966067
- Sponsor's protocol ID
- DDUH2011/09/07
- Status last verified
- Jan 2018
- First submitted
- 4 Nov 2016
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02966067
- Acronym / sponsor ID
- DDUH2011/09/07
- Conditions
- Dental Pain, Anesthesia, Local
- Keywords
- Microneedles, Dental Anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- Tyndall National Institute
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 8 Dec 2017 (actual)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microneedle Device | Experimental | 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 | Active comparator | Device: 30-gauge Short Hypodermic NeedleLocal Dental Anaesthetic Solution Delivery System: Standard thirty-gauge short hypodermic needle to inject anaesthetic solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- •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).
Key exclusion criteria (9 listed)
- Individuals will be excluded from the study if they suffer from the following conditions:
- Interventions not permitted during the study include the use of steroids, analgesics or other non-steroidal inflammatory drugs and smoking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microneedle Device (Experimental)Also: Local Dental Anaesthetic Solution Delivery SystemInjection 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. | Device | Microneedle Device |
| 30-gauge Short Hypodermic NeedleAlso: Local Dental Anaesthetic Solution Delivery SystemInjection 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. | Device | 30-gauge Short Hypodermic Needle |
Primary outcome
Pain Evaluation
Time frame: Immediately after injection of the anaesthetic
Discomfort / pain intensity rating will be recorded by using a visual analogue scale (VAS)
5 secondary outcomes
Pain Experience
Time frame: Immediately after injection of the anaesthetic
Electronic Pulp Test
Time frame: 15 minutes after injection
Thermal Pulp Test
Time frame: 10 minutes after injection
Pin-Prick Test
Time frame: 2 minute intervals alternating with fine touch test until onset of soft tissue anaesthesia
Fine Touch Test
Time frame: 2 minute intervals alternating with pin-prick test until onset of soft tissue anaesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darius Sagheri principal investigator
University of Dublin, Trinity College
Ciarán P Devine principal investigator
University of Dublin, Trinity College
June H Nunn principal investigator
University of Dublin, Trinity College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedle Device (Experimental) and 30-gauge Short Hypodermic Needle in people with Dental Pain and Anesthesia, Local, run by University of Dublin, Trinity College at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Evaluation (time frame: Immediately after injection of the anaesthetic). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.