Local Anesthesia With Computerized Device for Restorative Procedures in Pediatric Patients
Condition: Dental Pain and Sensation Disorder; Dental Caries in Children
MeSH terms: Dental Caries; Sensation Disorders
Study type: Interventional

Summary: 
      The aim of the present study is to assess if there are differences on perceived pain during
      local anesthesia performed with SleeperOne device or with a traditional syringe in pediatric
      patients.

      Patients responding to the inclusion criteria will be asked to participate to the study.
      After signing the informed consent, they will undergo local anesthesia procedure on first or
      second primary molars for the subsequent performing of dental filling. The split-mouth design
      will randomly allocate first or second primary molar from one quadrant to SleeperOne
      procedure, while the contralateral one will be subdued to local anesthesia with traditional
      syringe.

      After the procedure, patients will be asked to assess the perceived pain with a Visual
      Analogue Scale from a range 0-10. VAS scales will be used to assess sensations of "size"
      (related to the two instruments), bitter and vomit.
    

Detailed description: 
      The aim of the present study is to assess if there are differences on perceived pain during
      local anesthesia performed with SleeperOne device or with a traditional syringe in pediatric
      patients.

      Patients responding to the inclusion criteria will be asked to participate to the study.
      After signing the informed consent, they will undergo local anesthesia procedure on first or
      second primary molars for the subsequent performing of dental filling. Teeth will be randomly
      allocated to the two different local anesthesia types according to a split-mouth design:
      first or second primary molar from one quadrant will undergo SleeperOne anesthesia, while the
      contralateral one will undergo local anesthesia with traditional syringe.

      After the procedure, patients will be asked to assess the perceived pain with a Visual
      Analogue Scale from a range 0-10. VAS scales will be used to assess sensations of size
      (related to the two instruments), bitter and vomit.

      Sample size calculation (alfa = 0.05; power = 95%) for two independent study group and a
      continuous primary endpoint is performed concerning the primary outcome "VAS scale for pain".
      An expected mean of 2.6 with an expected mean difference of 1.7 and a standard deviation of
      1.84 are hypothesized [Palm et al., 2004]; therefore, 30 teeth per group are required and a
      total of 30 patients for the split-mouth design study should be enrolled.

      Statistical analysis will be performed. Data normality of distribution will be assessed with
      Kolmogorov-Smirnov test. Subsequently, the most appropriate test will be conducted to compare
      VAS differences between the two groups for the four variables "pain", "size", "bitter",
      "vomit".

      Linear regressions will be performed to assess of the following independent variables on
      "pain", "size", "bitter" and vomit": technique, quadrant, dental arch, tooth, dentition, sex,
      age.
    

Intervention name(s): local anaesthetic injection
Intervention type(s): Drug
Intervention description(s): Local anesthetic injection of articaine 4% + adrenaline 1/100.000 (Septanest, Septodont, Saint Maur des Fossés, France) with 30G - 9 mm needle (DENTAL HI TEC, ZI de l'Appentière, Mazières-en-Mauges, France).
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split-mouth design
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dental anesthesia