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NCT Number: NCT02591797

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

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.

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Key information

Conditions

Dental Anxiety Behavior Child Behavior Heart Rate and Rhythm Disorders Infant Behavior Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

36 month–71 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Facultad de Odontología. Universidad Cardenal Herrera CEU

Valencia, 46010, Spain

About this study

Children will be randomly allocated to treatment groups (n=26 for each group) according to the technique: 1)"Hands/Eyes/mouth" and 2) Conventional. Anxiety and pain will be evaluated by the Scale of facial Image (EIF) and Wong-Baker Pain Scale, respectively. The cooperation of the patient will be evaluated by behavioral Scale Frank

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Preschool children with severe dental caries who need dental pulp treatment and/or tooth extraction of inferior primary molars

Exclusion criteria

  • Preschool children with history of allergies to lidocaine (local anesthetic)
  • Preschool children with systemic or neurological diseases
  • Preschool children who have received local dental anesthesia before this study
  • Preschool children who do not understand Spanish or Valencian language

Treatment and study plan

inferior alveolar and lingual nerve block procedure

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:

  • Topical Anesthetic: Benzocaine 20% (Hurricaine, Clarben Laboratories SA, Madrid, Spain).
  • Dental Needle: short needles (21mm/30g) (Octoplus, Clarben Laboratories SA, Madrid, Spain)
  • anesthetic: lidocaine hydrochloride 2% with epinephrine 1: 100,000 (2% XILOCAINE, Dentsply, Spain).
  • Syringe: carpule syringe-conventional harpoon with suction system.

Other names: inferior alveolar and lingual nerve block

Primary outcomes

  1. Preschool children´s anxiety levels-Facial Image Scale (FIS)

    Time frame: Baseline

    The children will be asked to point at which face they felt most like at that moment (row of five faces ranging from very happy to very unhappy-FIS)

Secondary outcomes

  1. Preschool children´s pain levels-Wong Baker Faces Pain Scale

    Time frame: At the end of local anesthesia procedure (2 minutes)

    The children will be asked to point at which face they felt most like at that moment (row of six faces ranging from very happy-does not hurt to very unhappy-hurt as much as you can imagine)

Other outcomes

  1. Preschool children´s behavior-Frank behavioral rating Scale

    Time frame: baseline and during the local anesthesia procedure (2 minutes)

    It will be evaluated children´s behavior (definitely negative, negative,definitely positive, positive)during the local anethesia procedure

  2. Heart rates

    Time frame: baseline and during the local anesthesia procedure (2 minutes)

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Registry information

Official study title

Effectiveness of Hand/Eyes/Mouth Behavior Management Technique in Anxiety, Pain and Behavior Levels During an Inferior Alveolar and Lingual Nerve Block Procedure in Preschool Children: a Randomized Clinical Trial

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 30, 2015
Registry last updated
Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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