Comparison of Intraosseous Anesthesia Osteocentral With Electronic Assistance to Injection With Conventional Anesthesia
Condition: Pain
Study type: Interventional

Summary: 
      Anesthesia systems with electronic injection assistance for slow injection pressure-limiting
      drips (especially for intraosseous anaesthesia) are offered to limit pain. The European
      Academy of Pediatric Dentistry (EAPD) recommends them for their pen-like appearance which
      avoids the negative aspect of the classic syringe (Kühnisch 2017). A review systematic review
      of the literature (Smolarek et al 2019) including 20 randomized controlled trials conducted
      at children and adolescents showed a significant reduction in pain with the systems with
      electronic assistance compared to conventional anaesthesia performed with a syringe (-0.8:
      IC95% (-1.3, -0.3)). Only four of them (Tahmassebi et al 2009, Kandiah and Tahmassebi 2012,
      Patini et al 2018, Smail-Faugeron et al 2019) were at low risk of bias, and only two parallel
      group trials were of poor quality and included only children in temporary dentition in which
      anaesthesia, often problematic, was performed only in the maxilla (Allen et al 2002, Klein et
      al, 2005) without assessing the intensity of the pain felt.

      (FPS-R).

      The tested strategy, anesthesia system with electronic injection assistance (SleeperOne® 5
      Dental Hi Tec), compared to a conventional metallic anaesthetic syringe currently considered
      as the standard for performing local anesthesia during oral treatments painful, meets the ISO
      13485: 2016 standard.

      Elements justifying that the particular surveillance modalities added by research do not
      involve negligible risks and constraints

      Specific monitoring modalities added by research include :

        -  Explanation of the study to each eligible child and his or her legal guardians

        -  Gathering the informed consent of the child and his or her legal guardians

        -  The determination of comparative anesthesia systems (SleeperOne® 5 versus syringe metal)

        -  Data collection during the two care sessions (maximum 15 days apart)

      It is a use of a product placed on the market whose conditions of use are in conformity with
      its destination and its current conditions of use (RIPH Category 2 application decree) There
      is no additional consultation or visit, nor any additional examination, in relation to the
      management in accordance with the recommendations of good practice of a child affected by a
      carious disease corresponding to the children included. On the other hand, the consultation
      will take a little longer due to the indicators to be collected and the data entry. These
      particular surveillance modalities added by research have only negligible constraints.
    


Intervention name(s): sleeper one; conventional technis
Intervention type(s): Device; Device
Intervention description(s): anesthesic injection with sleeper one device; anesthesic injection with the conventional technic
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a multicentre, randomized, split-mouth, randomized controlled trial in which the experimental and control anesthetic systems will be randomly assigned to the teeth (randomization unit) of the tooth pair. controlerals considered in the same patient. This design allows a gain in power, each subject being its own witness without any carry-across effect, the two treatments being separated by one to two weeks ("split-mouth cross-over").
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention