Pain and Anxiety Evaluation in Children Using Different Techniques of Local Anesthesia for Dental Treatment
Condition: Pediatric Dentistry; Local Anesthesia; Pain Management
Study type: Interventional

Summary: 
      Fear and dental anxiety are often associated with the use of needles and syringes for local
      anesthesia, and painful perception during the administration of local anesthetics is often
      the main reason for anxiety behaviors and defensive reactions. Dental trauma originates in
      childhood, through experience misconduct. The objective of this study is to evaluate the pain
      and anxiety related to 4 different modalities of anesthesia in children. Will be selected
      volunteers aged between 5 and 12 years who need restorative dental treatment in posterior
      teeth in the upper 2 quadrants. All patients will receive 1 modality of anesthesia:
      conventional anesthesia (control group), computerized anesthesia, Dental Vibe anesthesia and
      computerized anesthesia + DentalVibe anesthesia. Evaluations will be made with physiological
      and behavioral criteria. For the physiological evaluation will be measured the blood
      pressure, respiratory rate, heart rate, oximetry and salivary cortisol before and during each
      anesthesia. As criteria for evaluation of anxiety will be applied the methods, Corah and
      modified VPT before anesthesia and modified VPT will be repeated after anesthesia. The pain
      will be assessed at the end of each anesthesia with Visual Analogue Scale (VAS) and Wong
      Baker Faces. The results will be submitted to parametric and non-parametric statistical
      analysis, according to the data obtained in the different evaluation criteria.
    


Intervention name(s): Local anesthesia with traditional technique; Local anesthesia with computerized technique; Local anesthesia with DentalVibe technique; Topic anesthesia; Local anesthetic
Intervention type(s): Device; Device; Device; Drug; Drug
Intervention description(s): Puncture with short needle in the region of the apical third of the tooth to be anesthetized Injection of local anesthetic, with speed 1ml / min; Puncture with short needle in the region of the apical third of the tooth to be anesthetized according to the recommendations of the manufacturer Injection of local anesthetic with computerized anesthesia equipment, with speed 0.5 ml / min; Use of DentalVibe in the apical region of the tooth to be anesthetized according to the manufacturer's guidelines Puncture with short needle enters the tips of the DentalVibe Injection of local anesthetic with traditional carpule, with speed 1 ml / min; Application of topical anesthetic for 60 seconds with benzocaine; 2% lidocaine with epinephrine 1: 100000 1.8 mL
Other intervention name(s): Traditional anesthesia; Conventional anesthesia; Computerized anesthesia; DentalVibe anesthesia; Topical anesthesia; Anesthetic
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The total sample is divided into two subgroups, with 105 children aged 5 to 8 years and 105 children aged 9 to 12 years. The analysis is more sensitive and specific to each subgroup. The results of each subgroup will be analyzed in isolation and give rise to two different papers.
Masking: Single (Investigator)
Primary purpose: Device Feasibility