Assessment of Needleless Jet Injection in Pain and Anxiety Management During Vital Pulpotomy of Primary Molars
Condition: Anesthesia
Study type: Interventional

Summary: 
      To evaluate and compare the efficiency of needleless jet injection versus traditional
      inferior alveolar nerve block anesthesia in management of pain and anxiety during vital
      pulpotomy of lower second primary molars using Wong-Baker FACES Pain Rating Scale and
      Venham's anxiety and behavioral rating scale..
    

Detailed description: 
      One of the most effective ways to control pain during invasive dental procedures is the use
      of local anesthesia which considers the most painful phase of treatment. The idea of
      receiving an injection is fear-inducing for many individuals, both children and adults which
      can lead patients to avoid dental treatments. Although such fears are outside the control of
      dentists, some treatment aspects can be modified to increase patient comfort.(1)

      Dental care may be associated with pain which may be intertwined with fear and anxiety,
      especially among children with treatment needs. The pain intensity is multiplied by having
      higher dental anxiety, a disability, age less than 14 years old and gender (female). The
      young patient's pain expectations may also add to the situational complexity. Consequently,
      dental health care may be perceived as insurmountable problem. (2) Administrating an
      anesthetic agent with a traditional syringe causes discomfort during the puncture and
      injection stages. (3) Incorrect handling of the syringe is a determining factor for pain (4),
      which is exacerbated due to excessive pressure on the plunger and rapid injection of large
      volumes of anesthetic solution.(5)

      To minimize the painful sensation during local anesthesia, other methods can be adopted, such
      as applying topical anesthetics prior to injection (6), using computerized injection systems,
      and using needleless jet injection systems (7). A needleless system includes a spring coupled
      to an apparatus that generates sufficient Pressure to (8) push the plunger of the ampoule
      (9)and makes the anesthetic solution pass through a micro orifice at high speed.

      The absence of a needle in a jet injection can result in a more comfortable experience, as
      this eliminates the puncture and injection phases, which are considered the most painful
      steps during traditional anesthesia (3). This difference is important as approximately one in
      five adults have phobia of dental anesthesia due to fear of injections, which leads to
      interruption of dental treatment (10).

      Since there are no studies about the efficacy of needleless jet injection systems during
      pulpotomy of lower second primary molars, the aim of this clinical trial was to evaluate and
      compare the efficiency of needleless jet injection versus traditional inferior alveolar nerve
      block anesthesia in management of pain and anxiety during vital pulpotomy of lower second
      primary molars
    

Intervention name(s): Needleless jet injector
Intervention type(s): Device
Intervention description(s): Device consist of injection pen, ampule and activator.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment