Effectiveness of DentalVibe in Reducing Injection Pain and Anxiety During Local Anaesthesia in Children
Condition: Pain Management; Local Anaesthesia
Study type: Interventional

Summary: 
      The aim of this study is to determine the effectiveness of DentalVibe (DV) in reducing
      injection pain and anxiety associated with local anaesthesia in paediatric patients.

      The clinical trial is a randomized split-mouth assignment. Included patients are 8-12 years
      old requiring local anesthetic infiltration with conventional syringe (CS) for extraction of
      two primary maxillary molars bilaterally. Eligible patients undergo two single-visit
      treatments after CFSS-DS measurement before each, where as DV is allocated to either first or
      second local anaesthesia procedure. Primary outcome measure will be pain felt during
      injection, reported by patient on VAS. Secondary outcome measures: self-reported anxiety
      during injection on FIS; pain-related behavior according to FLACC scale; heart-rate dynamics;
      patient preference to local anaesthesia method - CS or CS+DV.
    

Detailed description: 
      Achieving local anaesthesia in children is one of the critical aspects of pain management.

      In recent years, several innovative dental appliances have been developed on the concept to
      reduce the pain of needle injection by applying pressure, vibration, microoscillations or a
      combination of them.

      Тhe aim of this study is to determine the effectiveness of DentalVibe (DV) in reducing
      injection pain and anxiety associated with local anaesthesia in paediatric patients.

      The clinical trial is a randomized split-mouth assignment. Included patients are healthy
      positive children 8-12 years old requiring local anesthetic infiltration for extraction of
      two primary maxillary molars bilaterally.

      Eligible patients undergo two single-visit treatments after CFSS-DS measurement of dental
      fear prior to each. Local anaethetic is delivered through buccal infiltration with
      conventional syringe, where as DentalVibe Comfort System Injection is allocated to either
      first or second local anaesthesia procedure. Primary outcome measure will be pain felt during
      injection, reported by patient on visual analogue scale. Secondary outcome measures:
      self-reported anxiety during injection on Facial Image Scale; pain-related behavior according
      to FLACC scale; heart-rate dynamics; patient preference to local anaesthesia method -
      traditional infiltration or DentalVibe-assisted injection.
    

Intervention name(s): Local anaesthesia with conventional syringe; Local anaesthesia with conventional syringe + Dentalvibe
Intervention type(s): Procedure; Device
Intervention description(s): Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized.
Local anaesthetic infiltration speed 1ml/min. Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL; Buccal infiltration in posterior maxillary region. The tip of the DentalVibe device is placed in the mucobuccal fold above the tooth to be anesthetized. The device is activated for 5 s. A 27 gauge short needle is inserted as close as possible to the inner side of the prong while the vibration is still on.
Local anaesthetic infiltration speed 1ml/min. After injection the needle is withdrawn and vibration continues for another 5 s.
Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized Intervention Model: Split-mouth assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pain control; paediatric dental patients; local anaesthesia; dentalvibe