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

NCT03176446 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2020-04-30

No results posted yet for this study

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.

Conditions

  • Pediatric Dentistry
  • Local Anesthesia
  • Pain Management

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

Sponsors & Collaborators

  • Universidade Estadual de Ponta Grossa

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2018-11-30
Completion
2019-03-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03176446 on ClinicalTrials.gov