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

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 Overview

• Status: Completed
• Conditions: Local Anesthesia; Pain Management; Pediatric Dentistry
• Intervention / Treatment: Device: Local anesthesia with traditional technique; Drug: Topic anesthesia; Drug: Local anesthetic; Device: Local anesthesia with computerized technique; Device: Local anesthesia with DentalVibe technique

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Paraná
    • Ponta Grossa, Paraná, Brazil, 84030900
      • Ponta Grossa State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / 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: Conventional anesthesia; Traditional 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	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; 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
ACTIVE_COMPARATOR: DentalVibe Group; The children anesthesia will be DentalVibe technique	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; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidade Estadual de Ponta Grossa

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2017
• Primary Completion (ACTUAL): November 30, 2018
• Study Completion (ACTUAL): March 1, 2019

Study Registration Dates

• First Submitted: May 12, 2017
• First Submitted That Met QC Criteria: June 1, 2017
• First Posted (ACTUAL): June 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 28, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: 64773417.3.0000.5689

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Approval of the ethics committee
   Information identifier: 1.941.369

Drug and device information, study documents

• 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