Effect of the DentalVibe Injection System on Pain During Local Anesthesia Injections in Children

Up to 50 children between the ages of 5-11 years will participate in this randomized,
controlled, split-mouth study. There will be no gender restrictions used in this study.
Participants will be recruited from a continuous sample of patient seen at the UNMC pediatric
dental clinic and will be selected based on their need for dental treatment. Each child will
have 2 separate dental appointments.

Written consent will be obtained from parent or guardian prior to first restorative
appointment. Verbal consent will be obtained prior to second restorative appointment.

Dr. Marshall will be the provider for every patient. The same dental assistant will be used
for each appointment. All treatment will be completed in the same private quiet room. Both
Dr. Marshall and the dental assistant will wear the same color scrubs and black lab jackets
during all appointments.

One appointment patient will receive local anesthetic dental injection with the DentalVibe
turned on and at one appointment the child will receive local anesthetic dental injection
with the DentalVibe off. Used strictly as a check/lip retractor. The child will be randomly
assigned via a random number generator to either the DentalVibe on or off during the initial
appointment. During the DentalVibe turned on appointment, the DentalVibe will be introduced
to each child to make him/her familiar with the vibration sensation.

All patients will receive 5 mins of O2, then nitrous oxide (N2O) will be titrated up to
50%N2O/50%O2. When appointment is complete the child will receive 5 mins of 100% O2.

At both restorative appointment a cotton tip applicator with 20% Benzocaine topical
anesthetic gel (Patterson) will be administered for 1 min. 2% Lidocaine HCl with
1:100,000epinepherine (Patterson Dental) will the be deposited using a medium-length (0.4mm)
with 27-gauge short needles. Local anesthetic injections will be referred to as "sleepy
juice." Buccal and lingual infiltration will perform on the maxilla. Mandibular blocks will
be performed on the mandible. One cartridge of local anesthetic will be used at each
appointment. After administration, patient will be shown the Wong Baker FACES pain rating
scale and asked to rate the amount of discomfort experienced during the injection by pointing
to the face or number. The following manuscript will be used:

"Each face represents a person who has no hurt, or some hurt, or a lot of hurt." "Face 0
doesn't hurt at all. Face 2 hurts just a little bit. Face 4 hurts a little bit more. Face 6
hurts even more. Face 8 hurts a whole lot. Face 10 hurts as much as you can imagine, although
you don't have to be crying to have this worst pain." "Touch the face of the hurt you felt
when I gave you the sleepy juice."

After child has rated pain Dr. Marshall will continue with restorative treatment. The same
process will be followed at the second appointment. Appointments will be scheduled 3-4 weeks
apart.

Inclusion Criteria:

- Children between the ages of 5-11 who require dental treatment that requires bilateral
local anesthesia on the maxilla or mandible. Subjects must understand and speak
English.

Exclusion Criteria:

- No children with presence of medically or developmentally compromising conditions
(autism, cerebral palsy, moderate/severe asthma); history of chronic disease (seizure
disorder, cardiac disorder, hematological disease, endocrine disorder, liver disease,
renal disease). Non-English speakers will be excluded. Subject who require oral
sedation or general anesthesia for treatment due to behavior or medical history will
be excluded.