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Effectiveness of Hand/Eyes/Mouth Behavior Management Technique During Local Anesthesia in Preschool Children

NCT02591797 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2017-07-19

No results posted yet for this study

Summary

This will be a randomized, controlled, parallel-group clinical trial. The aim of this studio will be to evaluate the effectiveness of "Hands/Eyes/mouth" behavior management technique versus a conventional technique (covering the patient´s vision) during an inferior alveolar and lingual nerve block in preschool children referred for treatment at the School of Dentistry, Cardenal Herrera CEU University (Valencia, Spain). The sample will consist of 52 children from 3 years old to 5 years 11 months old who need dental pulp treatment and/or tooth extraction of primary molars. Preschool children with no history of allergies to Lidocaine or systemic/neurological diseases and who did not take local anesthesia before the study will be include in this research.

Conditions

  • Dental Anxiety
  • Pain
  • Infant Behavior
  • Heart Rate and Rhythm Disorders

Interventions

PROCEDURE

inferior alveolar and lingual nerve block procedure

The needle is inserted laterally to the pterygomandibular pit at its deepest point without noticing any resistance. In children the positioning of the syringe must be perpendicular, between the canine and the first molar on the opposite side and puncture is performed slightly below the occlusal plane. It was initially deposited 2/3 anesthetic carpule solution and then the needle is slightly recede depositing there the remaining third of anesthetic solution. The application of anesthesia shall be in accordance with the following guidelines: 1. Topical Anesthetic: Benzocaine 20% (Hurricaine, Clarben Laboratories SA, Madrid, Spain). 2. Dental Needle: short needles (21mm/30g) (Octoplus, Clarben Laboratories SA, Madrid, Spain) 3. anesthetic: lidocaine hydrochloride 2% with epinephrine 1: 100,000 (2% XILOCAINE, Dentsply, Spain). 4. Syringe: carpule syringe-conventional harpoon with suction system.

Sponsors & Collaborators

  • Cardenal Herrera University

    lead OTHER

Principal Investigators

  • Marta Ribelles Llop, PhD · Director of Pediatric Dentistry Master. Cardenal Herrera CEU University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
36 Months
Max Age
71 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-06-30
Completion
2017-07-31

Countries

  • Spain

Study Locations

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Entities

Diseases

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 NCT02591797 on ClinicalTrials.gov