Evaluation of Pain Perception and Heart Rate in Children Who Received Dental Anesthesia
Condition: Dental Anxiety
Study type: Interventional

Summary: 
      The aim of this single-blind split-mouth study is to compare traditional syringe technique
      versus computer-controlled Wand® anesthetic System to evaluate pain perception, assessed with
      Visual Numerical Rating Scale, and heart rate in children requiring at least two tooth
      extractions on opposite sides of the maxilla. The investigators suppose that the feeling of
      fear during anesthesia administration is related to the use of the conventional syringe and
      that the pain to the lack of control of the plunger of the syringe.

      The computer-controlled delivery system allows the operator to hide the needle and to control
      the pressure exerted during anesthetic administration.
    

Detailed description: 
      The sample of this single-blind split mouth study will be made up of 76 consecutive children
      (38 men and 38 female) between 5 and 12 years attending the Paediatric Dentistry Unit of
      Catholic University of Sacred Heart, Rome, Italy, from November 2016 for routinary dental
      treatments who needed at least two dental extractions on both left and right maxillary
      arches. The participants will have to be in good general health state with no
      contraindications to local anesthetics. Exclusion criteria are: suffering from any medical
      condition that could alter pain perception or taking any antibiotic or antinflammatory drugs
      in the last month before the procedures. A detailed informed written consent form will be
      signed by each patient's parent or guardian of children enrolled in this study before every
      clinical procedure. Patients will be informed that a computer controlled and traditional
      syringe techniques will be used for their dental procedures. No patients should have
      previously experienced a conventional syringe technique nor the Wand® injection. The sample
      size was calculated performing a power analysis based on the results of previous studies to
      detect at least a 1 grade Numerical Visual Rating Scale difference with Standard Deviation of
      1.05 and at least a 3 mmHg difference with Standard Deviation of 4 mmHg between groups. The
      alpha and beta values were set as 0.01 and 0.95 respectively and the sample size was
      calculated to be 30 subjects for each group.

      MEASURES Pain perception will be explained to patients before injections. The Numerical
      Visual Rating Scale is a pain scale based on Visual rating scale and Numerical rating scale
      that was used for the same purpose on adults in a previous report. This scale demonstrated to
      be easier to understand by the patients and was preferred to other scales that could have
      caused difficulties in evaluation by the children. Heart rate will be assessed using a pulse
      oximeter before and after the injection.

      PROCEDURES One half of the maxilla will be anesthetized using the Wand® system and the
      contralateral half by a conventional syringe. In both halves the intraligamentary technique
      will be the sole used. Anesthesia will be administered by the same previously calibrated
      operator. The order of techniques will be randomly selected. Randomization will be obtained
      through a random sequence generated by a Personal Computer. A distraction technique for
      palatal injections, in the form of pressure applied using the handle of the dental mirror,
      will be used before needle's insertion in both techniques. Following the intraligamentary
      technique the needle will be inserted parallel to the long axis of the tooth into the sulcus
      of each root and some drops of the local anesthetic solution will be administered before the
      needle entered the tissue. After few seconds the needle will be advanced penetrating the
      tissue and an additional amount of solution will be administered. The Wand® will be set on a
      pre-programmed injection mode named "Single Tooth Anesthesia" (speed mode 0,005 mL/sec). Once
      anesthesia will be achieved, tooth extractions will be performed. Patients should have been
      previously blindfolded with a commonly used sleeping mask so they will not distinguish which
      anesthetic delivery system was being used. Anesthesia procedures and tooth extractions will
      be completed in the same session according to a split-mouth design. The Wand® system produces
      audible beeps that will be deactivated. Immediately after delivery of local anesthetic,
      children will be asked to remove their mask and rate the pain felt during the anesthetic
      administration.

      All patients will receive mepivacaine 3% with a vasoconstrictor (Carbocaine 20 mg/ml with
      epinephrine 1:100.000 Dentsply Italy srl). A 1.8 mL anesthetic cartridge will be used for
      both procedures (Wand® vs. traditional). The local anesthetic will be injected with an
      extra-short 30 gauge dental needle for both Wand® (30 G handpiece and needle, Milestone
      Scientific) and with a traditional 30 Gauge needle (Trend Ject 0.30x21mm) for conventional
      injections.

      The following data will be collected through the use of a structured form:

        1. Patient's age

        2. Patient's gender

        3. Number of tooth/teeth extracted

        4. Score on Visual numerical Rating Scale

        5. Heart Rate before injection

        6. Heart Rate after injection

      STATISTICAL ANALYSIS All analyses will be performed using a commercially available software
      program (SPSS®, version 20.0, SPSS Inc., Chicago, Illinois, USA). Exploratory statistics
      revealed that all variables were normally distributed with equality of variances.

      Pain perception and Heart Rate changes during injection will be evaluated and paired t-test
      will be used to assess statistical significance for each outcome. All comparisons will be
      considered significant at p < 0.05.
    

Intervention name(s): Dental anesthesia
Intervention type(s): Procedure
Intervention description(s): A tooth extraction will be performed
Other intervention name(s): Device: computer controlled delivery system named Wand®
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study has a split-mouth model so participants will be anesthetized in one half of the maxilla with a conventional syringe and in the other half with the computer controlled delivery system.
The anesthetic techniques will be the same in the two haves.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Child; RCT; Anesthesia; Tooth extraction