Skip to main content
Clinical Trials/NCT03176446
NCT03176446
Completed
Not Applicable

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

Universidade Estadual de Ponta Grossa1 site in 1 country210 target enrollmentOctober 1, 2017

Overview

Phase
Not Applicable
Intervention
Local anesthesia with traditional technique
Conditions
Pediatric Dentistry
Sponsor
Universidade Estadual de Ponta Grossa
Enrollment
210
Locations
1
Primary Endpoint
Self-perception of pain
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2017
End Date
March 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Priscila de Camargo Smolarek

PhD student

Universidade Estadual de Ponta Grossa

Eligibility Criteria

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.

Arms & Interventions

Control Group

The children anesthesia will be traditional technique

Intervention: Local anesthesia with traditional technique

DentalVibe Group

The children anesthesia will be DentalVibe technique

Intervention: Topic anesthesia

Control Group

The children anesthesia will be traditional technique

Intervention: Topic anesthesia

Control Group

The children anesthesia will be traditional technique

Intervention: Local anesthetic

Computerized Group

The children anesthesia will be computerized technique

Intervention: Local anesthesia with computerized technique

Computerized Group

The children anesthesia will be computerized technique

Intervention: Topic anesthesia

Computerized Group

The children anesthesia will be computerized technique

Intervention: Local anesthetic

DentalVibe Group

The children anesthesia will be DentalVibe technique

Intervention: Local anesthesia with DentalVibe technique

DentalVibe Group

The children anesthesia will be DentalVibe technique

Intervention: Local anesthetic

Outcomes

Primary Outcomes

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

Pain Behavior

Time Frame: During the anesthetic procedure

The pain will be analyzed by the FLACC

Secondary Outcomes

  • SCARED Questionnaire(Before anesthesia)
  • Corah Questionnaire(Before anethesia)
  • VPT modified(Before anethesia and immediately after anesthesia)
  • Blood pressure(Immediately before anesthesia, during anesthesia)
  • Respiratory rate(Immediately before anesthesia, during anesthesia)
  • Heart rate(Immediately before anesthesia, during anesthesia)
  • Oxygen saturation(Immediately before anesthesia, during anesthesia)
  • Salivary cortisol(Immediately before anesthesia, during anesthesia)

Study Sites (1)

Loading locations...

Similar Trials