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

Sponsor
Universidade Estadual de Ponta Grossa (Other)
Overall Status
Completed
CT.gov ID
NCT03176446
Collaborator
(none)
210
1
3
17
12.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Local anesthesia with traditional technique
  • Device: Local anesthesia with computerized technique
  • Device: Local anesthesia with DentalVibe technique
  • Drug: Topic anesthesia
  • Drug: Local anesthetic
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
210 participants
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.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
Official Title:
Pain and Anxiety Evaluation in Children Using Different Techniques of Local Anesthesia for Dental Treatment
Actual Study Start Date :
Oct 1, 2017
Actual Primary Completion Date :
Nov 30, 2018
Actual Study Completion Date :
Mar 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control Group

The children anesthesia will be traditional technique

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
Other Names:
  • Traditional anesthesia
  • Conventional anesthesia
  • Drug: Topic anesthesia
    Application of topical anesthetic for 60 seconds with benzocaine
    Other Names:
  • Topical anesthesia
  • Drug: Local anesthetic
    2% lidocaine with epinephrine 1: 100000 1.8 mL
    Other Names:
  • Anesthetic
  • Active Comparator: Computerized Group

    The children anesthesia will be computerized technique

    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
    Other Names:
  • Computerized anesthesia
  • Drug: Topic anesthesia
    Application of topical anesthetic for 60 seconds with benzocaine
    Other Names:
  • Topical anesthesia
  • Drug: Local anesthetic
    2% lidocaine with epinephrine 1: 100000 1.8 mL
    Other Names:
  • Anesthetic
  • Active Comparator: DentalVibe Group

    The children anesthesia will be DentalVibe technique

    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
    Other Names:
  • DentalVibe anesthesia
  • Drug: Topic anesthesia
    Application of topical anesthetic for 60 seconds with benzocaine
    Other Names:
  • Topical anesthesia
  • Drug: Local anesthetic
    2% lidocaine with epinephrine 1: 100000 1.8 mL
    Other Names:
  • Anesthetic
  • Outcome Measures

    Primary Outcome Measures

    1. Self-perception of pain [Immediately after anesthesia]

      The pain will be analyzed by the Wong Baker Faces scales

    2. Pain Behavior [During the anesthetic procedure]

      The pain will be analyzed by the FLACC

    3. Self-perception of pain [Immediately after anesthesia]

      The pain will be analyzed by the Visual Analogue Scale (0-10). 0- no pain, 10- severe pain

    Secondary Outcome Measures

    1. SCARED Questionnaire [Before anesthesia]

      Children will be evaluated for the anxiety behavior prior to any anesthesia by answering the SCARED questionnaire

    2. Corah Questionnaire [Before anethesia]

      Children will be evaluated for the dentistry anxiety prior to any anesthesia

    3. VPT modified [Before anethesia and immediately after anesthesia]

      Children will be evaluated for the anxiety after to any anesthesia

    4. Blood pressure [Immediately before anesthesia, during anesthesia]

      The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of blood pressure

    5. Respiratory rate [Immediately before anesthesia, during anesthesia]

      The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of respiratory rate

    6. Heart rate [Immediately before anesthesia, during anesthesia]

      The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of heart rate

    7. Oxygen saturation [Immediately before anesthesia, during anesthesia]

      The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of oxygen saturation

    8. Salivary cortisol [Immediately before anesthesia, during anesthesia]

      The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of salivary cortisol

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ponta Grossa State University Ponta Grossa ParanĂ¡ Brazil 84030900

    Sponsors and Collaborators

    • Universidade Estadual de Ponta Grossa

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Priscila de Camargo Smolarek, PhD student, Universidade Estadual de Ponta Grossa
    ClinicalTrials.gov Identifier:
    NCT03176446
    Other Study ID Numbers:
    • 64773417.3.0000.5689
    First Posted:
    Jun 5, 2017
    Last Update Posted:
    Apr 30, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 30, 2020