PEDIATRIC DENTISTRY V 36 I NO 1 ]AN í FEB M

Clinical Article RANDOMIZED CONTROL TRIAL

Effect of the DentalVibe Injection System on Pain During Local Anesthesia Injections In
Adolescent Patients
David Ching, DMD' • Matthew Finkelman, PhD^ • Cheen Y. Loo, BDS, MPH, PhD, DMD'

Abstract: Purpose: The purpose of this study was to compare the pain rating scale measurements from an exposure group (injections with the aid
of DentalVibe Injection Comfort System) and control group (traditionai injection without the aid of the DentaiVibe) in adoiescent patients using
self-reported pain during administration of local anesthetic injections. Methods: This was a randomized, controlled study. Subjects consisted of 36
10- to 17-year-old patients who required local anesthesia for dentai treatment on both sides of the maxiila or mandible. All subjects received a
conventional injection (control) and an injection using DentalVibe (experimental). A pain rating for each injection was obtained from subjects
using the Wong-Bai<er FACES Pain Rating Scaie. Results: Statistical anaiysis using a Wiicoxon signed rank test found a significant reduction in pain
ratings for injections with the DentalVibe when compared to control injections. There was a positive correiation between the pain rating for
control injection and the difference between the two types of injection, indicating that subjects who reported a higher pain score with the controi
injection had a greater reduction when DentalVibe was used. Conclusion: When compared to a conventional approach, DentalVibe significantiy
lowered self-reported pain during locai anesthesia injection for adolescent subjects in this study (Pediatr Dent 2014:36:51-5) Received September 18,
2012 I Last Revision January 4,2013 I Accepted January 4, 2013

KEYWORDS: LOCAL ANESTHESIA, PAIN, INJECTIONS

Dental procedures are associated with pain and discomfort,
which is considered one of the main reasons for dental fear and
anxiety, with possible severe consequences for the individual's
future dental health. When children experience pain during
dental treatment, they may exhibit greater behavioral problems
at subsequent visits, resulting in greater need for behavior gui-
dance. Injection of local anesthetic is among the most feared
and anxiety-producing procedures during dental intervention'
and may cause subsequent unfavorable behavior.^' It is the
dental procedure that produces the greatest negative response in
children.'' Of even greater concern is the fact that children who
experience discomfort may avoid necessary dental care and may
be more likely to avoid future care as adults.'
As control of pain and anxiety is one of the most important
aspects in administration of local anesthetic in dental practice,
numerous methods have been developed to address the discom-
fort associated with dental injections. Psychological techniques,
such as distraction with audiovisual glasses, have been used
successfully to reduce the pain associated with injections.** An-
other study has shown that precooling of the soft tissues of an
injection site can minimize the discomfort and anxiety associ-
ated with the injection procedure.^
One of the injection systems developed to minimize pain
and discomfort during local anaesthesia injection is the Wand
system, a computer-automated injection system that provides
a precise injection How rate." In previous studies with children,
divergent results were found. Studies have shown lower pain
ratings for injections with the Wandvs injections with a con-
ventional syringe,**'^ while another study reported lower pain
ratings upon deposition of the anesthetic solution using the
'Dr. Ching is a pédiatrie dentist in private practice. Pearl City, Hawaii: 'Dr Finhelman
is an assistant professor. Department of Research Administration, and ^Dr. Loo is an massager,^'''" a vibrating syringe attachment,"''^ or a vibrating
associate professor and postdoctoral program director. Department of Pédiatrie Dentis- swab for topical anesthetic application." Use of the Vibraject,
try, both ot the School of Dental Medicine, Tufts University, Boston. Mass.. USA.
Correspond with Dr Loo at c.loo@tufts.edu
Wand system but similar pain ratings for needle insertion."
Other studies reported no difference between the two injection
methods.'''•" Distraction and counterstimulation, as well as
vibration stimuli, have been found to be effective in reducing
a pain reaction induced by injection of local anesthetic agents.""''^
The "gate control" theory of Melzack and Wall, proposed
in 1965, suggests that the pain experience can be reduced by
activating nerve fibers that conduct non-noxious stimuli.'*'"
This theory proposed that the spinal cord contains a neurolog-
ical "gate" that either blocks pain signals or permits them to
travel up the spinothalamic tract to the brain. Stimulation of
the larger diameter fibers through touch signal mechanore-
ceptors (eg, massage techniques, rubbing, pressure, ice packs,
acupuncture, or vibration) causes a release of inhibitory neurons,
preventing the activation of projection neurons at the synaptic
junction in the dorsal horn of the spinal cord, resulting in a
closure of the gate to the sensation of pain. "'"^° The efFects of
vibration on pain have been reported in both clinicaF'"^' and
experimental^'' settings.
Lundeberg et al. reported reduction of pain during vibra-
tory stimulation in patients suffering acute or chronic mus-
culoskeletal pain of different origins.^' In the orofacial region,
vibration stimuli have been used to raise the pain threshold,^*^'^^
to relieve pain of dental origin, whether pulpal, periodontal, or
postsurgical,^^ and to help manage acute or chronic musculo-
skeletal pain.^''-^* A study investigating the effect of vibration
on pain during local anesthesia injections found that, compared
to no vibration-stimulus injections, injections with vibration
resulted in less pain and lower pain ratings.^'
Numerous methods have been developed to cause stimula-
tion of the mechanoreceptors during delivery of dental injec-
tions in order to reduce pain during injections. The use of
vibration stimuli during injections has included a personal
a small device attached to a traditional dental syringe to transfer
a vibrating stimulus to the needle, did not result in a significant

DENTALVIBE VS. TRADITIONAL INJECTION 51

PEDIATRIC DENTISTRY V 36 ; NO 1 JAN / EEB 14
dectease in pain scotes at needle insettion ot anesthetic in-
A newly matketed technology, the DentalVibe, is a cotd-
less, techatgeable, handheld device that delivets pulsed, per-
cussive micro-oscillations to the site whete an injection is being
administered. The device is atttactive because it tequites no
modification to the ttaditional anesthetic ptotocol, including
injection technique, patient positioning, and time involved. If
effective, the device may tepresent a time-efficient, nonphar-
macological technique to improve the expetience of patients
teceiving local anesthetic duting dental ptocedures. To the best
of out knowledge, no study has been published on the effec-
tiveness of the DentalVibe.
Therefore, the purpose of this study was to compare the
pain tating scale measurements ftom an exposure gtoup (injec-
tions with the aid of DentalVibe Injection Comfort System)
and conttol gtoup (ttaditional injection without the aid of the
DentalVibe) in adolescent patients using self-reported pain
duting administtation of local anesthetic infiltration injections.
We hypothesized that the amount of discomfott expetienced
with the use of the DentalVibe injection comfort system duting
intta-otal injections would be less than ttaditional intra-otal
injections of local anesthetics in the adolescent patient.
Methods
This investigation involved a randomized, conttolled, split-
mouth study of adolescents teceiving local anesthesia fot tou-
tine dental tteatment. The study ptocedute was apptoved by the
Institutional Review Board at Tufts Medical Centet and Tufts
Univetsity Health Sciences Campus, Boston, Mass, and infotmed
consent was obtained from each subject's patent ot legal guatdian.
The study compated the pain tating scale measurements from
an exposure gtoup (injections with the aid of DentalVibe
Injection Comfott System) and conttol gtoup (ttaditional in-
jection without the aid of the DentalVibe). The study was
petfotmed accotding to a split-mouth design, with both types
of injections given to all subjects. A sample size calculation
was performed using nQuety Advisot 7.0 softwate (Statistical
Solutions, Inc, Saugus, Mass., USA). Assuming a mean differ-
ence of 3.0 between gtoups, and a standard deviation of 3.0, a
sample size of N=36 was adequate to achieve a type I etror rate
of a (alpha) =fivepetcent and a powet ovet 99 percent.
Subjects. A total of 36 healthy and coopetative subjects
wete selected ftom patients attending the clinic in the Depart-
ment of Pediattic Dentistty, Tufts University School of Dental
Medicine. Subjects wete selected on the basis of planned dental
tteatment that necessitated local anesthesia administtation
by infiltration injections fot dental tteatment in both sides of
the maxilla ot mandible. The inclusion ctitetia were: 10 to 17
yeats old; no medically ot developmentally comptomising
No Hurts Hurts
Hurt Uttle Bit unie More
Figure 1. Wotlg Baker FACES Pain Rating Scale.''
52 DENTALVIBE VS. TRADITIONAL INJECTION
conditions; English speaking; and in need of dental tteatment
tequiting bilatetal local anesthesia via infilttation injections in
the posteriot tegion of the mouth. The exclusion ctiteria were:
ptesence of tnedically ot developmentally comptomising condi-
tions (eg, autism, cerebtal palsy, modetate/sevete asthma); his-
toty of chtonic disease (eg, seizute disotdet, catdiac disotdet,
hematological disordet, endocrine disotdet, liver disease, renal
disease); and currently taking medication which contraindicated
the use of local anesthetic.
Procedure. Subjects were tandomly assigned, using R 2.11.1
softwate (R Foundation fot Statistical Computing, Vienna,
Austtia), to teceive the injection accotding to the ttaditional
technique (control) at one visit, while the DentalVibe (BING
Innovations, Boca Raton, Fla., USA) was used for the other
injection (expetimental). Ptiot to all injections, topical anesthesia
gel containing 20 petcent benzocaine (Centtix, Shelton, Conn.,
USA) was placed on dtied soft tissue in the atea of the injection
site fot two minutes. Fot all injection ptocedures, local infiltra-
tion with a 30-gauge extra-short needle with two percent
lidocaine containing 1:100,000 epinephrine (Novocol, Cam-
bridge, Ontario, Canada) was used to anesthetize patients. Each
subject received 0.85 ml of the anesthetic solution, which was
delivered at a constant täte ovet 30 to 40 seconds. All injections
wete timed and performed by one opetatot using standatd-
ized techniques in ordet to control for opetatot-related variables
such as ptevious expetience and technical expettise.
Duting the anesthesia injection, the conttol injection was
administered using the ttaditional method. To conttol fot po-
tential subject-expectancy effects and ptessure ftom placement
of the DentalVibe, it was placed near the injection site for all
injections; howevet, it was not tutned on for the conttol injec-
tions. The DentalVibe comfort tip was used as a tetractor in
the same mannet as a dental mirror. The comfort tip ptongs
wete positioned on the soft tissue in the area of the injection,
and the lip was tettacted with the same sttength as with a den-
tal mittot.
When the expetimental injections wete administered, all
ptocedutes wete identical, except fot the fact that the Dental-
Vibe was tutned on to stimulate the area of intended needle
penetration. After five seconds of vibration, the needle was
insetted close to one of the ptongs on the comfott tip. The
DentalVibe continued vibtation duting needle insettion and
anesthetic delivery. Aftet the anesthetic was deliveted, the
needle was temoved, followed by temoval of the DentalVibe.
Pain assessment. Immediately aftet each injection, sub-
jects wete asked to täte the amount of discomfott expetienced
duting the injection ftom 1 to 10, with 1 being no pain and 10
being wotst pain, using the Wong Baket FACES Pain Rating
Scale in Fisute 1 .'^
10
Hurts Hurts
Even More Whol® Lot Worst
 PEDIATRIC DENTISTRY V 36 ! NO 1 JAN i FEB 14

injection were significantly higher (median=3, inter-

D Control
quartile range=2.5, range=O to 8) than the Den-
• wnh DMitalVibe talVibe injection (median=l, interquartile range=2,
range=0-5). The median "difference" (pain rating with
control injection minus pain rating with DentalVibe
I injection) was 2, with an interquartile range of 3 and
ranging from -4 to 8.
There was a positive correlation between pain
rating after the control injection and the difference
(Spearman's correlation coefficient=0.79, P<.00\),
indicating subjects who reported higher pain rating
with the control injection had a greater reduction in
pain rating when DentalVibe was used during the

I
injection (Figure 3). There was no statistically signifi-
cant correlation between age and difference in pain

1
11
2 3 4 5 6 7 8 9 10 11 12 13 14 16 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 :
rating (Spearman's correlation coefficient=0.023,
i'=.89).
The Mann-Whitney U test, used to determine
Subject
whether there was a statistically significant associa-
tion between difference in pain ratings and gender
Figure 2. Graph showing the perceived pain as measured on the Wong Baker FACES or sequencing of the injections, found no significant
Pain Rating Scale after control and DentalVibe injections for each of the 36 subjects. effect for either (7^=.64 and P=.27, respectively).

After administration of the standardized amount of anes-
thesia and the completion of the pain assessment, additional
anesthesia was provided, if necessary. The amount of additional
anesthetic and route of administration was determined and
administered by the dentist completing the dental treatment.
Statistical analysis. Statistical analyses were performed
using the Wilcoxon signed rank test, Spearman correlation, and
Mann-Whitney U test. All analyses were conducted using SAS
9.1 software (SAS Institute Inc, Cary, N.C., USA). The five
percent level of significance was adopted (ie, a P-value of <.O5
was considered statistically significant).
Results
This study included a total of 36 10- to 17-year-old subjects
(median age=l4 years old)—15 males and 21 females. Nine-
teen subjects had the first injection with the traditional tech-
nique (control), and 17 subjects had the first injection with
the DentalVibe. The difference in reported pain ratings
(difFerence=pain rating from control injection minus pain rating
with the DentalVibe), with positive values indicating greater
pain during the control injection. Thirty subjects (-83 percent)
found the injection with the DentalVibe to be less painful
than the injection with the traditional technique, while three
(-eight percent) found the injection with the DentalVibe to be
more painful than the control injection (Figure 2). Three of the
36 subjects (-eight percent) found the two techniques to be
Discussion
This study applied the gate control theory of pain modulation to
determine whether large A-beta nerve fiber input from a vibra-
tion stimulus would inhibit smaller fiber A-delta and C fiber
(nociceptive) input from an intraoral infiltration injection. The
study revealed that vibration applied using the DentalVibe
decreased pain associated with a local anesthetic injection de-
livered via infiltration. Most subjects (83 percent) found the
injection with the DentalVibe to be less painful than the injec-
tion with the traditional technique, while approximately eight
percent found the injection with the DentalVibe to be more
painful than the control injection. Subjects in the DentalVibe
group had significantly lower pain scores than those in the
control group.
These results agree with the findings of Nanitsos et al.,
who found that adult subjects in the vibration group exhibited
>•
*
Difference

equally painful. The subjects who found the injection with the *

DentalVibe to be more painful than the control injection had

low pain ratings (0 or 1) with the control injection.
* *
Interestingly, 17 subjects (-47 percent) reported no pain
0•
with the DentalVibe injection (pain rating=O). In comparison, 4 7
only three subjects (-eight percent) felt no pain with the con-
ventional injection, and one of these three subjects also felt no •1 <

pain with the DentalVibe. Pain during infiltration injection was

eliminated in a total of 16 subjects (-44 percent) with the use
of the DentalVibe when compared to the traditional technique.
Using the Wilcoxon signed rank test, the data showed
there was a statistically significant difference in the self-report-
ed pain using the Wong-Baker FACES pain sale between the
two types of injections (PK.OOI). Pain ratings after the control
-4
Control
Figure 3. Scatterplot between pain raring of control injection and the difference
in pain rating (difference-pain rating from control injection minus pain rating
with the DentalVibe; Spearman correlation coefficient=0.79, P<.001).

DENTALVIBE VS. TRADITIONAL INIECTION 53

PEDIATRIC DENTISTRY V 36 i NO 1 JAN i EEB 14
significantly less pain during local anesthesia injections vs. the
control group.^' This agreement may be attributed to the larger
area of stimulus in the two techniques. By contrast, use of the
Vibraject, a vibrating attachment for a traditional syringe, did
not reduce the subjects' pain. The possible reason may be that
the vibrations were extremely small and did not activate the
large nervefibersin that area for many individuals.'^
A correlation was observed between the pain rating with
the eontrol injeetions and the differenee between the control
and the DenvalVibe injections. There was a higher reduction
of perceived pain with the DentalVibe in subjects with a higher
pain response during the control injection. This was in agree-
ment with the findings of Palm, Kirkegaard, and Poulsen, who
investigated the effect of pain during mandibular block injec-
tions using the Wand.** Their study found that there was a
significantly greater reduction in perceived pain with the Wand
in patients with a higher pain perception during traditional
injection.* As the level of dental anxiety may have a strong infiu-
enee on an individual's reaction, knowledge of each patient's
level of dental anxiety may help tailor treatment to the patient's
needs.
Three of the subjects reported the infiltration injection with
the DentalVibe to be more painful than the control injection.
Interestingly, all of these subjects reported low pain ratings
(0 or 1) with the control injection. This eould be attributed to
the fact that individuals were uncomfortable with the vibration
sensation experienced with the DentalVibe and reported this
discomfort as a higher pain rating. A previous study using vibra-
tion during local anesthesia also reported that, although most
subjects in the study reported less pain, a minority (19 percent)
experienced more pain when vibration was used.^'
Efforts were used to minimize differences between the two
procedures, such as timing each injection, placing the Dental-
Vibe near the injection site for all injections, having the same
experienced operator perform all the injections, and using topical
anesthesia before all injections to minimize pain during needle
insertion. As the anatomical location of an injection is an im-
portant determinant of pédiatrie pain reaetion,''' this study
evaluated injections administered in the posterior areas only.
A limitation to this study is that patients eould not be blinded
due to inherent physieal vibrational stimulation experieneed
with the DentalVibe. On the other hand, while the DentalVibe
was only turned on for those in the experimental group, it was
plaeed on all the subjeets, providing a eontrol for the potential
confounding influences of seeing the device in place. As sub-
jects were 10 to 17 years old, it is unknown if this technique
will be effective in a younger pédiatrie population. Further re-
search is planned to evaluate the effect of the DentalVibe on
a younger age group.
Conclusion
Based on this study's results, the following conclusion can be
made:
1. Use of the DentalVibe injection system significantly
reduced pain associated with infiltration injection of
local anesthesia in an adolescent population.
Acknowledgments
This study was supported by DHHS-HRSA grant no.
D84HP19955. The authors wish to thank Dr. Catherine De-
Furia for her assistance in preparing this manuscript.
54 DENTALVIBE VS. TRADITIONAL IN|ECTION
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Abstract of Electronic Publication in this Issue

Case Report

Calcium Enriched Mixture Cement for Primary Molars Exhibiting Root Perforations and Extensive Root
Resorption: Report of Three Cases
Sara Tavassoli-Hojjati, DD5, MS' • Somayeh Kameli, DDS-^ • Sara Rahimian-Emam, DDS^ • Maryam Ahmadyar, DDS" • Saeed Asgary, DDS, MS''

Abstract: In primary molars with root perforations of endodontic origin, tooth extraction and space maintainer are recommended. Calcium-
enriched mixture (CEM) cement is a new biomateriai demonstrating favorable sealabiiity/biocompatibiiity. This report presents a novel treat-
ment modality for cases of primary moiar teeth with root perforations associated with a periodontal lesion due to extensive inflammatory
root résorption, whereby CEM was used as a perforation repair/pulpotomy biomateriai. Three cases of primary molar root perforations due
to inflammatory résorption were selected; all cases were associated with furcal lesions of endodontic origin. Pulp chambers were accessed/
irrigated with NaOCI; the root canal oriflces were filled with CEM and restored with stainiess steel crowns. Clinical/radiographic exami-
nations up to 17 months revealed that all teeth were functional and free of signs/symptoms of infection and all had complete bone healing.
Further trials are suggested to conflrm CEM use for management of root perforations in primary molars exhibiting root perforation. (Pediatr
Dent 2OI4:36:E23-E27) Received December 31, 2012 I Last Revision April 6,2013 I Accepted April 7,2013

KEYWORDS: DENTITION PRIMARY, ROOT RESORPTION, CALCIUM-ENRICHED MIXTURE, CEM CEMENT, ENDODONTICS

DENTALVIBE VS. TRADITIONAL INJECTION 55

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