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

NCT02591797 | Completed

• 1 other identifier: AMLUCHBR
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pain; Infant Behavior; Heart rate; Dental Anxiety

Outcome Measures

Primary Outcomes (1)

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

  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)

  Baseline

Secondary Outcomes (1)

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

  At the end of local anesthesia procedure (2 minutes)

Other Outcomes (2)

• Preschool children´s behavior-Frank behavioral rating Scale

  baseline and during the local anesthesia procedure (2 minutes)

• Heart rates

  baseline and during the local anesthesia procedure (2 minutes)

Study Arms (2)

"hand-eye-mouth" technique

EXPERIMENTAL

"hand-eye-mouth" (MOB) seeks to focus the patient in performing a sequence of movements in a fun way so that your attention is diverted from the puncture dental needle, also it seeks to the patient does not see the needle. The operator prior to infiltrate local anesthetic teaches the child a "game" to put "the sleepy little water".After explain a first time, the sequence once or twice is repeated until the patient has mastered. We call this test. When we apply the anesthetic, the entire sequence must be repeated as in trials with the same tranquility and in the same tone of the game. The operator will use this technique during the inferior alveolar and lingual nerve block procedure

Procedure: inferior alveolar and lingual nerve block procedure

Conventional technique

ACTIVE COMPARATOR

the operator will explain how he/she will do the inferior alveolar and lingual nerve block procedure in phrases appropriates to the child. Then quietly cover the child´s field of view by hand during the inferior alveolar and lingual nerve block

Procedure: inferior alveolar and lingual nerve block procedure

Interventions

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: 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.

Also known as: inferior alveolar and lingual nerve block

"hand-eye-mouth" technique; Conventional technique

Eligibility Criteria

• Age: 36 Months - 71 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardenal Herrera University: lead

Study Sites (1)

Facultad de Odontología. Universidad Cardenal Herrera CEU

Valencia, 46010, Spain

Location

Related Publications (1)

• Leyda-Menendez AM, Vidigal EA, Abanto J, Ribelles-Llop M. Efficacy of two behavioural management techniques during inferior alveolar nerve block administration in pre-school children: a randomised clinical trial. Eur Arch Paediatr Dent. 2023 Feb;24(1):85-93. doi: 10.1007/s40368-022-00758-y. Epub 2022 Oct 19.

  PMID: 36260279 DERIVED

MeSH Terms

Conditions

Pain; Infant Behavior

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Child Behavior; Behavior

Study Officials

• Marta Ribelles Llop, PhD

  Director of Pediatric Dentistry Master. Cardenal Herrera CEU University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Associate Professor to the Pediatric Dentistry Master

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: October 30, 2015
• Study Start: October 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 19, 2017

Record last verified: 2017-07

Locations

ES (1)