Trial Outcomes & Findings for Evaluation of the Dental Vibe Injection Comfort System (NCT NCT04971941)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Measured during anesthesia procedure by the subject and recorded after each individual anesthesia procedure, an average of one minute

Results posted on

2023-02-03

Participant Flow

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.

Participant milestones

Participant milestones
Measure	DV3 With 1st LB Injection This group had DV3 only with 1st Long Buccal injection	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	DV3 With 2nd LB Injection This group had the DV3 used only during their 2nd long buccal injection	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
Overall Study STARTED	15	15	15	15
Overall Study COMPLETED	15	15	15	15
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DV3 With 1st LB Injection n=15 Participants DV3 with First Long Buccal Use of Dental Vibe during dental anesthesia intervention	DV3 With 1st LB Injection and IAN Block (3rd Injection) n=15 Participants Dental Vibe with first long buccal injection and IAN Dental Vibe: Use of Dental Vibe during dental anesthesia intervention	DV3 With 2nd LB Injection n=15 Participants DV3 with 2nd Long Buccal Injection Dental Vibe: Use of Dental Vibe during dental anesthesia intervention	DV3 With 2nd LB Injection and DV3 With 2nd LB and IAN Injections n=15 Participants DV3 with 2nd Long Buccal Injection and also with Inferior Alveolar injection	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=60 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=15 Participants	15 Participants n=15 Participants	15 Participants n=15 Participants	15 Participants n=15 Participants	60 Participants n=60 Participants
Age, Categorical >=65 years	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=60 Participants
Age, Continuous	23 years STANDARD_DEVIATION 1.5 • n=15 Participants	24 years STANDARD_DEVIATION 1 • n=15 Participants	27 years STANDARD_DEVIATION 1.5 • n=15 Participants	26 years STANDARD_DEVIATION 1 • n=15 Participants	25 years STANDARD_DEVIATION 1.25 • n=60 Participants
Sex: Female, Male Female	7 Participants n=15 Participants	8 Participants n=15 Participants	8 Participants n=15 Participants	7 Participants n=15 Participants	30 Participants n=60 Participants
Sex: Female, Male Male	8 Participants n=15 Participants	7 Participants n=15 Participants	7 Participants n=15 Participants	8 Participants n=15 Participants	30 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	15 Participants n=15 Participants	15 Participants n=15 Participants	15 Participants n=15 Participants	15 Participants n=15 Participants	60 Participants n=60 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Inferior Alveolar Block n=60 Participants Use of DentalVibe with or without inferior alveolar nerve block Use of DentalVibe during dental anesthesia intervention compared to inferior alveolar nerve block without DentalVibe	LB Injection With DV First n=30 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	Long Buccal Injection With DV Second n=30 Participants 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	SSI Tolerability LB Block DV First Long buccal (LB) nerve block with DV used first while opposite side LB done without DV done second	SSI Tolerabilty Long Buccal Block DV Second This group had LB without DV first and then DV was used for the opposite side LB injection	SSI Discomfort LB DV First Long buccal (LB) nerve block with DV used first while opposite side LB done without DV done second	SSI Discomfort LB DV Second Long buccal (LB) nerve block without DV done first while opposite side LB with DV done second	SSI Unpleasantness LB With DV First Long buccal (LB) nerve block with DV used first while opposite side LB done without DV done second	SSI Unpleasantness LB DV Second Long buccal (LB) nerve block without DV done first while opposite side LB done with DV done second
VAS with dental vibe	2.5 score on a scale Standard Deviation 1.48	2.3 score on a scale Standard Deviation 1.21	2.7 score on a scale Standard Deviation 1.46	—	—	—	—	—	—
VAS without dental vibe	4.2 score on a scale Standard Deviation 2.17	3.3 score on a scale Standard Deviation 1.75	4.0 score on a scale Standard Deviation 1.74	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Inferior Alveolar Block n=60 Participants Use of DentalVibe with or without inferior alveolar nerve block Use of DentalVibe during dental anesthesia intervention compared to inferior alveolar nerve block without DentalVibe	LB Injection With DV First n=60 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	Long Buccal Injection With DV Second n=60 Participants 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	SSI Tolerability LB Block DV First n=30 Participants Long buccal (LB) nerve block with DV used first while opposite side LB done without DV done second	SSI Tolerabilty Long Buccal Block DV Second n=30 Participants This group had LB without DV first and then DV was used for the opposite side LB injection	SSI Discomfort LB DV First n=30 Participants Long buccal (LB) nerve block with DV used first while opposite side LB done without DV done second	SSI Discomfort LB DV Second n=30 Participants Long buccal (LB) nerve block without DV done first while opposite side LB with DV done second	SSI Unpleasantness LB With DV First n=30 Participants Long buccal (LB) nerve block with DV used first while opposite side LB done without DV done second	SSI Unpleasantness LB DV Second n=30 Participants Long buccal (LB) nerve block without DV done first while opposite side LB done with DV done second
SSI with dental vibe	4.8 score on a scale Standard Deviation 3.02	6.2 score on a scale Standard Deviation 4.31	5.8 score on a scale Standard Deviation 4.04	4.0 score on a scale Standard Deviation 3.23	5.0 score on a scale Standard Deviation 3.77	5.3 score on a scale Standard Deviation 3.04	6.8 score on a scale Standard Deviation 4.5	5.3 score on a scale Standard Deviation 3.51	6.5 score on a scale Standard Deviation 4.36
SSI without dental vibe	8.9 score on a scale Standard Deviation 5.67	10.2 score on a scale Standard Deviation 5.42	9.8 score on a scale Standard Deviation 5.90	6.0 score on a scale Standard Deviation 4.66	7.6 score on a scale Standard Deviation 4.72	7.9 score on a scale Standard Deviation 4.21	9.1 score on a scale Standard Deviation 4.06	7.6 score on a scale Standard Deviation 4.67	8.8 score on a scale Standard Deviation 4.60

SECONDARY outcome

Timeframe: After procedure until lip numbness, an average of four minutes

Population: time to complete mandibular anesthesia was measured

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

Outcome measures

Outcome measures
Measure	Inferior Alveolar Block n=60 Participants Use of DentalVibe with or without inferior alveolar nerve block Use of DentalVibe during dental anesthesia intervention compared to inferior alveolar nerve block without DentalVibe	LB Injection With DV First 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	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	SSI Tolerability LB Block DV First Long buccal (LB) nerve block with DV used first while opposite side LB done without DV done second	SSI Tolerabilty Long Buccal Block DV Second This group had LB without DV first and then DV was used for the opposite side LB injection	SSI Discomfort LB DV First Long buccal (LB) nerve block with DV used first while opposite side LB done without DV done second	SSI Discomfort LB DV Second Long buccal (LB) nerve block without DV done first while opposite side LB with DV done second	SSI Unpleasantness LB With DV First Long buccal (LB) nerve block with DV used first while opposite side LB done without DV done second	SSI Unpleasantness LB DV Second Long buccal (LB) nerve block without DV done first while opposite side LB done with DV done second
Time in Minutes with Dentalvibe	6 minutes Standard Deviation 5.0	—	—	—	—	—	—	—	—
Time in Minutes without DentalVibe	7.8 minutes Standard Deviation 5.6	—	—	—	—	—	—	—	—

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jeffry R Shaefer

Harvard School of Dental Medicine

Phone: (781) 718-6793

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place