Effect of the DentalVibe Injection System on Pain During Local Anesthesia Injections in Children
Condition: Pain
Study type: Interventional

Summary: 
      Title: Effect of the DentalVibe injection system on pain during local anesthesia injections
      in children.

      Purpose: The purpose of this study is to compare self-reported pain scale measurements using
      the Wong-Baker FACES pain rating scale from an experimental group (local anesthesia injection
      with DentalVibe system) and a control group (traditional local anesthesia injection with
      DentalVibe system turned off) in children.

      Eligibility: Children age 5-11 years old who require local anesthesia for bilateral dental
      treatment at University of Nebraska Medical Center (UNMC) pediatric dental clinic. Children
      must understand and speak English.

      Interventions and evaluations: Each patient will have two separate restorative appointments
      where the DentalVibe will be used during local anesthetic injections. One appointment the
      DentalVibe will be turned on and one appointment the DentalVibe will be turned off. After
      each injection the child will be shown the Wong Baker FACES Pain Rating Scale and asked to
      pick a face associated with their level of hurt during the injection.

      Follow-up: All children will be followed up with any necessary recommended dental treatment.
    

Detailed description: 
      Up to 50 children between the ages of 5-11 years will participate in this randomized,
      controlled, cross-over, 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 hydrochloride (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.
    

Intervention name(s): DentalVibe
Intervention type(s): Device
Intervention description(s): The DentalVibe is a handheld device that delivers vibration to the tissue during local anesthetic administration.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a randomized cross-over clinical trial wherein the study subject serves as his or her own control.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care