Anesthesia, Local, Pain
Conditions
Keywords
Anesthesia, local, Pain
Brief 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 and the time needed to achieve complete anesthesia during an IAN block.
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.
Interventions
DEVICEDental Vibe
Use of Dental Vibe during dental anesthesia intervention
Sponsors
Harvard Medical School (HMS and HSDM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Able to volunteer for dental anesthesia -
Exclusion criteria
Non volunteer \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SSI | measured by subject during procedure but recorded directly after each procedure | 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. |
| Time in Minutes | After procedure until lip numbness, an average of four 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 |
Participant flow
Recruitment details
A total of 60 subjects participated in this study. Each participant had 3 procedures done (bilateral buccal nerve blocks one with or without the use of Dentalvibe, and then one inferior alveolar nerve (IAN) block for which 30 subjects had it done with the Dentalvibe and 30 subjects had it done without the use of the Dentalvibe. The IAN blocks with or w/o the Dentalvibe was chosen randomly.and which side went first with or without the Dentalvibe was also chosen randomly.
Participants by arm
| Arm | Count |
|---|---|
| DV3 With 1st LB Injection DV3 with First Long Buccal Use of Dental Vibe during dental anesthesia intervention | 15 |
| DV3 With 1st LB Injection and IAN Block (3rd Injection) Dental Vibe with first long buccal injection and IAN
Dental Vibe: Use of Dental Vibe during dental anesthesia intervention | 15 |
| DV3 With 2nd LB Injection DV3 with 2nd Long Buccal Injection
Dental Vibe: Use of Dental Vibe during dental anesthesia intervention | 15 |
| DV3 With 2nd LB Injection and DV3 With 2nd LB and IAN Injections DV3 with 2nd Long Buccal Injection and also with Inferior Alveolar injection | 15 |
| Total | 60 |
Baseline characteristics
| Characteristic | DV3 With 1st LB Injection and IAN Block (3rd Injection) | DV3 With 2nd LB Injection | DV3 With 2nd LB Injection and DV3 With 2nd LB and IAN Injections | DV3 With 1st LB Injection | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 15 Participants | 15 Participants | 60 Participants |
| Age, Continuous | 24 years STANDARD_DEVIATION 1 | 27 years STANDARD_DEVIATION 1.5 | 26 years STANDARD_DEVIATION 1 | 23 years STANDARD_DEVIATION 1.5 | 25 years STANDARD_DEVIATION 1.25 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Region of Enrollment United States | 15 Participants | 15 Participants | 15 Participants | 15 Participants | 60 Participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 7 Participants | 7 Participants | 30 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants | 8 Participants | 8 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 60 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 60 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 60 | 0 / 30 | 0 / 30 |
Outcome results
Primary
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.
Time frame: Measured during anesthesia procedure by the subject and recorded after each individual anesthesia procedure, an average of one minute
Population: Subjects getting IAN with or without DV, LB with DV used first, LB with DV used second
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inferior Alveolar Block | VAS | with dental vibe | 2.5 score on a scale | Standard Deviation 1.48 |
| Inferior Alveolar Block | VAS | without dental vibe | 4.2 score on a scale | Standard Deviation 2.17 |
| LB Injection With DV First | VAS | with dental vibe | 2.3 score on a scale | Standard Deviation 1.21 |
| LB Injection With DV First | VAS | without dental vibe | 3.3 score on a scale | Standard Deviation 1.75 |
| Long Buccal Injection With DV Second | VAS | with dental vibe | 2.7 score on a scale | Standard Deviation 1.46 |
| Long Buccal Injection With DV Second | VAS | without dental vibe | 4.0 score on a scale | Standard Deviation 1.74 |
Comparison: Sample size estimation from Nanitsos 2010: Using the P value from the paired T test with 61 degrees of freedom the T statistic calculated at 4.365. From mean difference 9.3 SD was calculated as 16.66 for an effect size of 0.558. This generated a sample size of 44 subjects, receiving 2 injections (1 with DV3 and 1 without), is necessary to attain 95% power for a paired t-test comparing the 2 pain measures at a two-tailed alpha level of 0.05. P value for IANp-value: 0.00195% CI: [0.4, 2.1]t-test, 2 sided
p-value: 0.0295% CI: [-1.7, -1.5]t-test, 2 sided
p-value: 0.00495% CI: [0.4, 2.1]t-test, 2 sided
Secondary
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.
Time frame: measured by subject during procedure but recorded directly after each procedure
Population: scale from 0-28 with zero being non discomfort, completely tolerable, no unpleasantness
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inferior Alveolar Block | SSI | with dental vibe | 4.8 score on a scale | Standard Deviation 3.02 |
| Inferior Alveolar Block | SSI | without dental vibe | 8.9 score on a scale | Standard Deviation 5.67 |
| LB Injection With DV First | SSI | with dental vibe | 6.2 score on a scale | Standard Deviation 4.31 |
| LB Injection With DV First | SSI | without dental vibe | 10.2 score on a scale | Standard Deviation 5.42 |
| Long Buccal Injection With DV Second | SSI | with dental vibe | 5.8 score on a scale | Standard Deviation 4.04 |
| Long Buccal Injection With DV Second | SSI | without dental vibe | 9.8 score on a scale | Standard Deviation 5.9 |
| SSI Tolerability LB Block DV First | SSI | with dental vibe | 4.0 score on a scale | Standard Deviation 3.23 |
| SSI Tolerability LB Block DV First | SSI | without dental vibe | 6.0 score on a scale | Standard Deviation 4.66 |
| SSI Tolerabilty Long Buccal Block DV Second | SSI | with dental vibe | 5.0 score on a scale | Standard Deviation 3.77 |
| SSI Tolerabilty Long Buccal Block DV Second | SSI | without dental vibe | 7.6 score on a scale | Standard Deviation 4.72 |
| SSI Discomfort LB DV First | SSI | without dental vibe | 7.9 score on a scale | Standard Deviation 4.21 |
| SSI Discomfort LB DV First | SSI | with dental vibe | 5.3 score on a scale | Standard Deviation 3.04 |
| SSI Discomfort LB DV Second | SSI | without dental vibe | 9.1 score on a scale | Standard Deviation 4.06 |
| SSI Discomfort LB DV Second | SSI | with dental vibe | 6.8 score on a scale | Standard Deviation 4.5 |
| SSI Unpleasantness LB With DV First | SSI | with dental vibe | 5.3 score on a scale | Standard Deviation 3.51 |
| SSI Unpleasantness LB With DV First | SSI | without dental vibe | 7.6 score on a scale | Standard Deviation 4.67 |
| SSI Unpleasantness LB DV Second | SSI | with dental vibe | 6.5 score on a scale | Standard Deviation 4.36 |
| SSI Unpleasantness LB DV Second | SSI | without dental vibe | 8.8 score on a scale | Standard Deviation 4.6 |
p-value: 0.00114% CI: [0.4, 4.8]t-test, 2 sided
p-value: 0.003t-test, 2 sided
p-value: 0.003t-test, 2 sided
p-value: 0.058t-test, 2 sided
p-value: 0.008t-test, 2 sided
p-value: 0.044t-test, 2 sided
p-value: 0.023t-test, 2 sided
p-value: 0.042t-test, 2 sided
p-value: 0.053t-test, 2 sided
Secondary
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
Time frame: After procedure until lip numbness, an average of four minutes
Population: time to complete mandibular anesthesia was measured
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inferior Alveolar Block | Time in Minutes | with Dentalvibe | 6 minutes | Standard Deviation 5 |
| Inferior Alveolar Block | Time in Minutes | without DentalVibe | 7.8 minutes | Standard Deviation 5.6 |
Comparison: The null hypothesis is that there is no relation between use of DV and numb times. There were no studies from which to perform a power calculation for this outcome measurep-value: 0.459t-test, 2 sided