Discomfort Evaluation During Atraumatic Restorative Treatment in Children

Faculty Sao Leopoldo Mandic Campinas40 enrolled

Overview

This study evaluates the patient 's discomfort when submitted to partial caries removal through the atraumatic restorative treatment compared to chemo-mechanical caries removal using Papacarie™ gel.

This study will evaluate the patient 's discomfort through oximeter (measuring the heart rate of the caries) prior to removal of the carious tissue, and when subjected to partial caries removal through the atraumatic restorative treatment compared to removal of chemo - mechanical caries with Papacarie gel ™.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dental Caries Primary Teeth Post Dental Restoration

Interventions

Caries removal using only manual instrumentsOTHER

Caries removal using only manual instruments according to Atraumatic Restorative Treatment

Caries removal using Papacarie gelOTHER

Caries removal using a chemical-mechanical method - Papacarie gel and manual instruments.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 9 Years

Medical Language ↔ Plain English

Inclusion Criteria: * normoreactive, * in good general health conditions, * cooperative during screening, * with at least one oclusal caries cavity in primary molars. * Caregivers and/or children's parents must accept and sign the consent form. * Children must accept their participation by nodding (assent). Exclusion Criteria: * pulp exposition, * spontaneous pain, * mobility, * fistula, * swollen area around the tooth, * furcation, * cervical lesion, * restorations, * sealants, * developmental defect of enamel.

Locations (1)

Faculdade Sao Leopoldo Mandic

Campinas, São Paulo, Brazil

Outcomes

Primary Outcomes

Discomfort evaluation with Wong-Baker

The discomfort of each type of treatment will be evaluated using the facial scale of Wong-Baker (Wong, Baker, 1998). This scale indicates the discomfort of an individual who has to choose among six faces. The first image is a smiling happy face, indicating no discomfort, followed by gradually less cheerful expressions, up to the last one which is a very sad face covered by tears, indicating great discomfort. The participant will be asked to choose the face that is more similar to how he/she felt during the treatment immediately after the procedure. This answer should be given solely by the child, which means no parental or professional interference

Time frame: immediately after treatment

Discomfort evaluation with heart beat and oxygen saturation

Time frame: Before the procedure (when the patient is in the dental chair and there is no intervention), and during the procedure (removal of the cavity tissue).

Secondary Outcomes

Time of restorative procedure

Time frame: Will be evaluated the time required for removal of the caries tissue only with manual removal and when manual removal with the product Papacárie ™

Operators satisfaction

Time frame: immediately after treatment

Data from ClinicalTrials.gov

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