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VibraJect- The Analgesic Syringe Clip Fact Sheet

What is the Competition to VibraJect?

The CompuDent with the Wand hand piece (formerly The Wand) and the Comfort Control
Syringe (CCS) from Dentsply are the competitors to VibraJect. A third competitor, the
IntraFlow dental anesthesia system from IntraVantage Inc. , was introduced at the
Chicago Mid-Winter Meeting, 2002, as was the VibraJect.

How Do Competitive Systems Compare With VibraJect?

CompuDent and CCS are similar systems to each other. They are electronic devices that
employ microprocessors that control the volume and pressure of local anesthetic. CCS
costs $891 and the CompuDent with Wand hand piece costs $1,395. Both systems
require the purchase of additional disposable items which cost about $1.10 for the Wand
and 52 cents for the CCS per usage.
Both products rely on giving the injection slowly to reduce the pain. This increases chair
time. The CompuDent requires a floor foot pedal in addition to the several already used
in the dental operatory. The CCS is bulky and somewhat awkward to use.
IntraFlow is a totally different concept that injects anesthetic directly into the bone. It
uses a pneumatic hand piece that is compatible with standard clinic equipment. A
disposable transfuser in the hand piece holds an anesthetic cartridge and a 24 gauge
rotating needle/drill. After a topical anesthetic is applied, the hand piece delivers the
anesthetic in a combined process of bone perforation, infusion and withdrawal. The cost
of this system is unknown.
VibraJect advantages: No electricity, no foot pedals, no hand piece or special needles,
no disposable items to increase costs, no special technique that could double the chair
time for an injection, no topical anesthetic and has an economical kit price of $269. It
attaches to conventional or disposable syringes including intraligamental syringes.

Do Dentists Need This Technology?

Statistics tell us that only 50 percent of the US population visit a dentist on a regular
basis. The other 50% need dental care but are fearful of the dental experience. These
statistics were published in 1985 by the NIDCR ( National Institute of Dental and
Craniofacial Research). One major association people have with pain in the dental office is
the fear of injections.
Dentists have given injections for years and have developed distracting techniques like
shaking the cheek while dispensing the anesthetic. Many will tell you that their injections
don’t hurt but the reality is that their injections are probably not painless. Theuse of an
instrument like VibraJect allows the dentist to consistently give more comfortable
injections.
There are injections that no matter how inventive the dentist is that hurt. Palatal,
intraligamental, PDL, and blocks are examples of such injections. VibraJect is
particularly effective with these injections.

Do These Products Work Equally Well for All Patients?

The answer is no. Pain research has shown a correlation between patient fear and pain.
There is a segment of patients that do not fear injections or have a higher pain tolerance
level. These patients may not feel a difference between an injection with or without an
anesthetic injection system.
However, it is impossible for the dentist to determine the pain tolerance capability of a
patient until an injection is given. Anesthetic injection systems cause no negative result to
this segment of patients but it gives a more comfortable experience to those patients that
experience injection pain.
A study completed by Queen’s University of Belfast, UnitedKingdom has quantified the
pain reduction results of using the VibraJect. Subjects receiving the conventional
injection methods had a mean pain score of 4.6 (± 0.414) The VibraJect group had a mean
pain score of 1.71 (±0.235)(P<0.05).
Children are a specific patient group that are developing their comfort level or fear to
dentistry. If pain could be removed from this patient group, the comfort level would be
developed for a lifetime. An anesthetic injection system can aid in the reduction/removal
of pain and fear.

How Does VibraJect Work?

VibraJect removes or reduces pain from injections based on the Gate Control Theory of
Pain Management. In a normal injection, the pain receptors indicate that “tissue damage”
is occurring. In contrast, pressure or vibration on areas of the mouth are interpreted
simply as “pressure” or “vibration”. When these signals are combined, as inthe case with
an injection using the VibraJect, the “tactile “ pathway has an inhibitory action on the
“pain” pathway at the dorsal horn ofthe spinal cord (or wherever these nerve fibers
actually connect). Thus, the patient doesn’t feel the pain, because the “pain signal” is
essentially masked by the “vibration” signal.
The VibraJect attachment effectively raises the pain threshold of the nerve tissue
involved during dental injections. This modulation of the pain threshold can be explained
for the following reasons.
First, of the variety of nerve cells in the human body, two types are most likely associated
with the pain reduction phenomenon created by the VibraJect attachment. These cells
include free nerve endings and mechanoreceptors or tactile nerves in the oral tissues.
The free nerve endings (receptors) are small nerve fibers without insulation. These
receptors respond relatively slowly to stimulation and their signal intensity is also
relatively low. These receptors are associated with sensing temperature and pain.
Tactile nerve cells (mechanoreceptors), such as Pacinian corpuscles, are larger as well
as insulated. These cells respond quickly to stimulation and have a relatively high signal
intensity. These receptors are associated with pressure and vibration; i.e., “tactile”
sensations.

The basic process of sensory nerve functions involves the following steps. First, the
receptor (nerve cell) receives a stimulus. Next, the receptor transforms the stimulus to a
nerve impulse. Finally, this impulse is passed on to the nerve fiber, and on to a series of
synapes that end up in the spinal cord, which communicates with the brain where
sensation is interpreted.

Sensory circuits are made up of the small and large nerve fibers that connect at synapse
junctions at the dorsal horn of the spinal cord. The types of sensations are interpreted as
pain, temperature change, pressure, etc. based on a complex filtering process involving
nerve signal differentials, among other interpretive functions.

How To Use The VibraJect?

The VibraJect attachment is a combination of a battery powered motor and clip bracket
that attaches to any conventional syringe. The clip bracket is autoclavable and it is
intended to remain on the syringe. The motor can be cleaned with alcohol or disinfecting
solution.

The attachment is clipped onto the syringe and can be positioned anywhere on the barrel
to provide maximum visibility. The motor is turned on by twisting a control knob on the
top of the motor. A topical anesthetic is not necessary when using the VibraJect
attachment. Use a standard injection technique for any injection including shaking the
cheek if desired.

The six batteries included in the Kit provide for approximately 200 injections.
Replacement batteries can be purchased in packages of 6 or 10 batteries through Fcop
Corporation (888-267-2737) or a local drug store or mass merchandiser. The batteries are 1.5V
batteries and two are required.

Installation of the Batteries:

Unscrew the control knob in a counter clockwise motion to remove. The batteries are
located in the top of the control knob. Batteries are placed into the control knob with the
wider, flat side facing to the top of the control knob. Screw in the control knob, clock
wise, until motor starts to operate and turn back
two full turns to stop to avoid drainage
of the batteries during non-usage.

Autoclavability:

The clip brackets are autoclavable and are intended to remain on the syringe. Additional
clip brackets are available through ITL Dental ( ask for code VJCB). The motor is not to be
autoclaved. Clean the motor with an alcohol wipe or disinfecting solution.

VibraJect Published Evaluations

CRA Associates Volume 26, Issue 12 December, 2002
Dental Economics December, 2002
Kisco Perspective Newsletter Volume #4
Reality Now February, 2003 No: 149

IF YOU HAVE ANY QUESTIONS, PLEASE CALL Fcop Corp  (888)267 2737