Pain and Anxiety Evaluation in Children Using Different Techniques of Local Anesthesia for Dental Treatment

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Device Feasibility
    • Masking: Single (Investigator)
  • Study Primary Completion Date: November 30, 2018

Interventions

  • Device: Local anesthesia with traditional technique
    • 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
  • Device: Local anesthesia with computerized technique
    • 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
  • Device: Local anesthesia with DentalVibe technique
    • 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
  • Drug: Topic anesthesia
    • Application of topical anesthetic for 60 seconds with benzocaine
  • Drug: Local anesthetic
    • 2% lidocaine with epinephrine 1: 100000 1.8 mL

Arms, Groups and Cohorts

  • Active Comparator: Control Group
    • The children anesthesia will be traditional technique
  • Active Comparator: Computerized Group
    • The children anesthesia will be computerized technique
  • Active Comparator: DentalVibe Group
    • The children anesthesia will be DentalVibe technique

Clinical Trial Outcome Measures

Primary Measures

  • Self-perception of pain
    • Time Frame: Immediately after anesthesia
    • The pain will be analyzed by the Wong Baker Faces scales
  • Pain Behavior
    • Time Frame: During the anesthetic procedure
    • The pain will be analyzed by the FLACC
  • Self-perception of pain
    • Time Frame: Immediately after anesthesia
    • The pain will be analyzed by the Visual Analogue Scale (0-10). 0- no pain, 10- severe pain

Secondary Measures

  • SCARED Questionnaire
    • Time Frame: Before anesthesia
    • Children will be evaluated for the anxiety behavior prior to any anesthesia by answering the SCARED questionnaire
  • Corah Questionnaire
    • Time Frame: Before anethesia
    • Children will be evaluated for the dentistry anxiety prior to any anesthesia
  • VPT modified
    • Time Frame: Before anethesia and immediately after anesthesia
    • Children will be evaluated for the anxiety after to any anesthesia
  • Blood pressure
    • Time Frame: Immediately before anesthesia, during anesthesia
    • The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of blood pressure
  • Respiratory rate
    • Time Frame: Immediately before anesthesia, during anesthesia
    • The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of respiratory rate
  • Heart rate
    • Time Frame: Immediately before anesthesia, during anesthesia
    • The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of heart rate
  • Oxygen saturation
    • Time Frame: Immediately before anesthesia, during anesthesia
    • The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of oxygen saturation
  • Salivary cortisol
    • Time Frame: Immediately before anesthesia, during anesthesia
    • The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of salivary cortisol

Participating in This Clinical Trial

Inclusion Criteria

  • Children of both sexes, aged between 5 and 12 years, requiring dental treatment under local anesthesia in the first permanent molars or deciduous maxilla. Exclusion Criteria:

  • The person responsible does not authorize the participation of the child as a research volunteer. – Be using pain modulating drugs. – Be using anxiety modulating drugs. – Patients with a history of hypersensitivity to local anesthetics. – Patients with a history of systemic diseases.

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Universidade Estadual de Ponta Grossa
  • Provider of Information About this Clinical Study
    • Principal Investigator: Priscila de Camargo Smolarek, PhD student – Universidade Estadual de Ponta Grossa

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