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Evaluation of Pain Perception and Heart Rate in Children Who Received Dental Anesthesia

NCT03348800 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2019-01-30

No results posted yet for this study

Summary

The aim of this single-blind split-mouth study is to compare traditional syringe technique versus computer-controlled Wand® anesthetic System to evaluate pain perception, assessed with Visual Numerical Rating Scale, and heart rate in children requiring at least two tooth extractions on opposite sides of the maxilla. The investigators suppose that the feeling of fear during anesthesia administration is related to the use of the conventional syringe and that the pain to the lack of control of the plunger of the syringe.

The computer-controlled delivery system allows the operator to hide the needle and to control the pressure exerted during anesthetic administration.

Conditions

  • Dental Anxiety

Interventions

PROCEDURE

Dental anesthesia

A tooth extraction will be performed

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • Massimo Cordaro, MD, Dean · Catholic University of Sacred Heart

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-22
Primary Completion
2017-11-22
Completion
2018-05-21

Countries

  • Italy

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 NCT03348800 on ClinicalTrials.gov