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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02578160
Other study ID # EBEMATECH
Secondary ID
Status Active, not recruiting
Phase N/A
First received October 12, 2015
Last updated October 22, 2016
Start date November 2015
Est. completion date November 2016

Study information

Verified date October 2016
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

This will be a randomized, controlled, parallel-group clinical trial. The aim of this study will be to evaluate the effectiveness of "Tell-Show-Do" 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, University of Sao Paulo, Brazil. 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 anesthetic or systemic/neurological diseases and who did not take local anesthesia before the study will be include in this research.


Description:

Children will be randomly allocated to treatment groups (n = 26 for each group) according to the technique: (1) Tell-Show-Do 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 Frankl.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 52
Est. completion date November 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Both
Age group 36 Months to 71 Months
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

1. Preschool children with history of allergies to Lidocaine (local anesthetic)

2. Preschool children with systemic or neurological diseases

3. Preschool children who have received local dental anaesthesia before this study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Intervention

Procedure:
inferior alveolar and lingual nerve block procedure
inferior alveolar and lingual nerve block

Locations

Country Name City State
Brazil Faculdade de Odontologia da Universidade de Sao Paulo Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
Evelyn Alvarez Vidigal

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Preschool children's anxiety levels changes before and after anesthesia procedure - 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 and after one week No
Secondary Preschool children's pain levels - Wong-Baker FACES Pain Scale The children were 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) At the end of the local anesthesia procedure (2 minutes) No
Secondary Preschool children's behavior - Frankl Behavioral Rating Scale It will be evaluated children's behavior (definitely negative, negative, definitely positive, positive) during de local anesthesia procedure Baseline and during the local anesthesia procedure (2 minutes) No
Secondary Heart rates Baseline and during local anesthesia procedure No
Secondary Parent's anxiety levels - Corah's dental anxiety scale (DAS) - parent questionnaire Baseline No
Secondary family socioeconomic indicators - questionnaire related to socioeconomic conditions questionnaire related to family socioeconomic conditions Baseline No
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