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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-07-31

Brief Summary

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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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Detailed Description

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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

Conditions

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Dental Anxiety Pain Infant Behavior Heart Rate and Rhythm Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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"hand-eye-mouth" technique

"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

Group Type EXPERIMENTAL

inferior alveolar and lingual nerve block procedure

Intervention Type 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.

Conventional technique

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

Group Type ACTIVE_COMPARATOR

inferior alveolar and lingual nerve block procedure

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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inferior alveolar and lingual nerve block

Eligibility Criteria

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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

Minimum Eligible Age

36 Months

Maximum Eligible Age

71 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No