Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DV3 with first LB injection | Active Comparator | Use of Dental Vibe with first long buccal block |
|
| DV3 with first LB and with IAN | Active Comparator | Dental Vibe with first long buccal injection and inferior alveolar block |
|
| DV3 with 2nd LB | Experimental | Use of DentalVibe with 2nd Long Buccal injection |
|
| DV3 with 2nd LB and IAN | Experimental | Use of DentalVibe with 2nd long buccal and inferior alveolar nerve block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental Vibe | Device | Use of Dental Vibe during dental anesthesia intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 during anesthesia procedure by the subject and recorded after each individual anesthesia procedure, an average of one minute |
| Measure | Description | Time Frame |
|---|---|---|
| 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 by subject during procedure but recorded directly after each procedure |
Not provided
Inclusion Criteria: Able to volunteer for dental anesthesia -
Exclusion Criteria: Non volunteer
-
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeffry R Shaefer, DDS MS MPH | Harvard School of Dental Medicine | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | DV3 With 1st LB Injection | This group had DV3 only with 1st Long Buccal injection |
| FG001 | DV3 With 1st LB Injection and IAN Block (3rd Injection) | This group had DV3 with their first Long Buccal injection and their IAN block injection |
| FG002 | DV3 With 2nd LB Injection | This group had the DV3 used only during their 2nd long buccal injection |
| FG003 | DV3 With 2nd LB Injection and IAN Block (3rd Injection) | This group had the DV3 used with their 2nd Long Buccal injection and during their IAN injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
60 subjects participated in the study. In the long bucal portion each subject had an injection with and without the Dental Vibe with the DV3 being used first on the left side in 30 subjects and first on the right side in 30 subjects while in the IAN part of the study 30 had an injection without the Dentalvibe and 30 with the Dentalvibe. Pain and tolerability, and time to complete anesthesia were compared.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DV3 With 1st LB Injection | DV3 with First Long Buccal Use of Dental Vibe during dental anesthesia intervention |
| BG001 | DV3 With 1st LB Injection and IAN Block (3rd Injection) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Subjects getting IAN with or without DV, LB with DV used first, LB with DV used second | Posted | Mean | Standard Deviation | score on a scale | Measured during anesthesia procedure by the subject and recorded after each individual anesthesia procedure, an average of one minute |
|
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.
Common dental anesthesia procedures were done during this study with no serious side affects anticipated. No participants had mild or serious affects during his/her procedure
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DV3 With First LB Block | Dental Vibe: Use of Dental Vibe during dental anesthesia intervention for Long Buccal only |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffry R Shaefer | Harvard School of Dental Medicine | (781) 718-6793 | jeffry_shaefer@hms.harvard.edu |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| After procedure until lip numbness, an average of four minutes |
Dental Vibe with first long buccal injection and IAN
Dental Vibe: Use of Dental Vibe during dental anesthesia intervention
| BG002 | DV3 With 2nd LB Injection | DV3 with 2nd Long Buccal Injection Dental Vibe: Use of Dental Vibe during dental anesthesia intervention |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Each subject had bilateral LB injections. These subjects had use of Dental Vibe during dental anesthesia intervention for the initial LB injection as compared to the second LB done on opposite side w/o DV |
| OG002 | Long Buccal Injection With DV Second | Dental Vibe: Use of Dental Vibe during dental anesthesia intervention after LB w/o DentalVibe was done initially with opposite side then receiving a LB with DentalVibe |
|
|
|
| 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. | scale from 0-28 with zero being non discomfort, completely tolerable, no unpleasantness | Posted | Mean | Standard Deviation | score on a scale | measured by subject during procedure but recorded directly after each procedure |
|
|
|
|
| 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 to complete mandibular anesthesia was measured | Posted | Mean | Standard Deviation | minutes | After procedure until lip numbness, an average of four minutes |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | DV3 With 1st LB and IAN Block | Dental Vibe with long buccal injection and IAN block | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | DV3 With 2nd LB | Dental Vibe: Use of Dental Vibe during dental anesthesia intervention for LB only | 0 | 15 | 0 | 15 | 0 | 15 |
| EG003 | DV3 With 2nd LB and IAN Block | Use of DV3 with LB and IAN blocks | 0 | 15 | 0 | 15 | 0 | 15 |
| EG004 | Inferior Alveolar Block | IAN block without DV | 0 | 60 | 0 | 60 | 0 | 60 |
| EG005 | LB Done First | LB done without DV | 0 | 30 | 0 | 30 | 0 | 30 |
| EG006 | LB Done 2nd | LB done without DV | 0 | 30 | 0 | 30 | 0 | 30 |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|
| without dental vibe |
|
|
| 0.003 |
| Superiority |
| t-test, 2 sided | 0.003 | Superiority |
| t-test, 2 sided | 0.058 | Superiority |
| t-test, 2 sided | 0.008 | Superiority |
| t-test, 2 sided | 0.044 | Superiority |
| t-test, 2 sided | 0.023 | Superiority |
| t-test, 2 sided | 0.042 | Superiority |
| t-test, 2 sided | 0.053 | Superiority |
|