Anesthesia, LocalDVRCTNCT04971941

Evaluation of the Dental Vibe Injection Comfort System

A study testing Dental Vibe in people with Anesthesia, Local and Pain, run by Harvard Medical School (HMS and HSDM).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study investigated the Dental Vibe Injection Comfort System (DV), developed to lessen anesthesia pain through pulsed vibration, a form of counter-stimulation. The study's aims were to evaluate DV's efficacy in reducing pain/discomfort from intra-oral long buccal (LB) and inferior alveolar nerve (IAN) injections… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Anesthesia, Local, Pain
What is being tested?: Dental Vibe
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: No sites listed yet
Study dates: Apr 2015to Nov 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

About this study

Read the detailed description

Objective: Pain from local anesthesia injections can be reduced by distraction and counter-stimulation techniques. This study investigated the Dental Vibe Injection Comfort System (DV), developed to lessen anesthesia pain through pulsed vibration, a form of counter-stimulation.

Design: Our study's aims were to evaluate DV's efficacy in reducing pain/discomfort from intra-oral long buccal (LB) and inferior alveolar nerve (IAN) injections and the time needed to achieve complete anesthesia during an IAN block.

Methods: The sixty subjects, equally split by sex, ages 21-32, rated injection pain on a visual analog scale and discomfort, unpleasantness, and difficulty in enduring the injection on a modified symptom severity index. Each subject received bilateral LB injections and an IAN block. Using block design, DV Generation 3 (DV3) was randomly assigned to either the first or second LB injection and to thirty subjects on their third injection, the IAN block. No topical anesthesia was applied.

Conditions: Anesthesia, Local, Pain
Being tested: Dental Vibe
Keywords: Anesthesia, local, Pain
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dental VibeDevice
Use of Dental Vibe during dental anesthesia intervention

Study groups in NCT04971941
Study group	Role	What they receive
DV3 with first LB injection	Active comparator	Use of Dental Vibe with first long buccal block Receives: Device: Dental Vibe
DV3 with first LB and with IAN	Active comparator	Dental Vibe with first long buccal injection and inferior alveolar block Receives: Device: Dental Vibe
DV3 with 2nd LB	Experimental	Use of DentalVibe with 2nd Long Buccal injection Receives: Device: Dental Vibe
DV3 with 2nd LB and IAN	Experimental	Use of DentalVibe with 2nd long buccal and inferior alveolar nerve block Receives: Device: Dental Vibe

What is being measured

The primary outcome is the main question the study is designed to answer.

VAS
VAS (visual analog scale) measured pain during anesthesia procedure on a scale from 0-10 with 0 being no pain and 10 being the most intense pain. The lowest number is the best outcome.
Measured: Measured during anesthesia procedure by the subject and recorded after each individual anesthesia procedure, an average of one minute

Secondary outcomes (2)

SSI
SSI measured tolerability, intensity, and unpleasantness of anesthesia procedure. Each has a scale from 0-28; with 0 being the least discomfort, least intolerable, and lowest intensity; whereas 28 is the most discomfort, most intolerable, and most intense.
Measured: measured by subject during procedure but recorded directly after each procedure
Time in Minutes
Time for complete inferior alveolar nerve block anesthesia with or without use of Dental Vibe measured in minutes. The time was recorded in minutes from when the anesthesia procedure was completed until the subject had a numb lip and could no longer feel cold (ice) applied to their ipsilateral canine tooth
Measured: After procedure until lip numbness, an average of four minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2015Nov 2015

First posted22 Jul 2021
Study startApr 2015
Primary completionNov 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Anesthesia, LocalStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04971941
Sponsor's protocol ID: IRB14-2778
Acronym: DVRCT
Status last verified: Jan 2023
First submitted: 28 Feb 2021
Last updated: 3 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Anesthesia, Local trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Dental Vibe Injection Comfort System
ClinicalTrials.gov ID: NCT04971941
Acronym / sponsor ID: DVRCT / IRB14-2778
Conditions: Anesthesia, Local, Pain
Keywords: Anesthesia, local, Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Harvard Medical School (HMS and HSDM)University, hospital or other
Study start: Apr 2015
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 22 Jul 2021 (actual)
Results: Posted 3 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
DV3 with first LB injection	Active comparator	Device: Dental VibeUse of Dental Vibe with first long buccal block
DV3 with first LB and with IAN	Active comparator	Device: Dental VibeDental Vibe with first long buccal injection and inferior alveolar block
DV3 with 2nd LB	Experimental	Device: Dental VibeUse of DentalVibe with 2nd Long Buccal injection
DV3 with 2nd LB and IAN	Experimental	Device: Dental VibeUse of DentalVibe with 2nd long buccal and inferior alveolar nerve block

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (1 listed)

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
Dental VibeUse of Dental Vibe during dental anesthesia intervention	Device	DV3 with 2nd LB, DV3 with 2nd LB and IAN, DV3 with first LB and with IAN, DV3 with first LB injection

Primary outcome

VAS
Time frame: Measured during anesthesia procedure by the subject and recorded after each individual anesthesia procedure, an average of one minute
VAS (visual analog scale) measured pain during anesthesia procedure on a scale from 0-10 with 0 being no pain and 10 being the most intense pain. The lowest number is the best outcome.

2 secondary outcomes

SSI
Time frame: measured by subject during procedure but recorded directly after each procedure
Time in Minutes
Time frame: After procedure until lip numbness, an average of four minutes

Results and safety

Results posted to the registry on 3 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DV3 With 1st LB Injection	15	15
DV3 With 1st LB Injection and IAN Block (3rd Injection)	15	15
DV3 With 2nd LB Injection	15	15
DV3 With 2nd LB Injection and IAN Block (3rd Injection)	15	15

Primary outcome: VAS

Time frame: Measured during anesthesia procedure by the subject and recorded after each individual anesthesia procedure, an average of one minute. Mean (Standard Deviation). Unit: score on a scale

Measure	Inferior Alveolar Block n = 60	LB Injection With DV First n = 30	Long Buccal Injection With DV Second n = 30
with dental vibe	2.5 (1.48)	2.3 (1.21)	2.7 (1.46)
without dental vibe	4.2 (2.17)	3.3 (1.75)	4.0 (1.74)

Inferior Alveolar Block: Mean Difference (Final Values): 1.7 (95% CI 0.4 to 2.1), p = 0.001, t-test, 2 sided
LB Injection With DV First: Mean Difference (Final Values): -1.6 (95% CI -1.7 to -1.5), p = 0.02, t-test, 2 sided
Long Buccal Injection With DV Second: Mean Difference (Net): 1.2 (95% CI 0.4 to 2.1), p = 0.004, t-test, 2 sided

Population analysed: Subjects getting IAN with or without DV, LB with DV used first, LB with DV used second

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: During time of injection and until full anesthesia was achieved and during the post anesthesia period of 2 hours. The timeframe for adverse events was 2 hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DV3 With First LB Block	0 of 15 (0%)	0 of 15 (0%)	0 of 15
DV3 With 1st LB and IAN Block	0 of 15 (0%)	0 of 15 (0%)	0 of 15
DV3 With 2nd LB	0 of 15 (0%)	0 of 15 (0%)	0 of 15
DV3 With 2nd LB and IAN Block	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Inferior Alveolar Block	0 of 60 (0%)	0 of 60 (0%)	0 of 60
LB Done First	0 of 30 (0%)	0 of 30 (0%)	0 of 30
LB Done 2nd	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Head and Neck Cancer (H&N)
Recruiting
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Musculoskeletal Diseases or Conditions
RecruitingPhase 3
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Prostate Cancer
Not yet recruiting
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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.

Jeffry R Shaefer, DDS MS MPH principal investigator

Harvard School of Dental Medicine

Questions about this trial

What is this clinical trial studying?

A study testing Dental Vibe in people with Anesthesia, Local and Pain, run by Harvard Medical School (HMS and HSDM).

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 0 inclusion and 1 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 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 3 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

VAS (time frame: Measured during anesthesia procedure by the subject and recorded after each individual anesthesia procedure, an average of one minute). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04971941.

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 3 Feb 2023.