Discomfort Evaluation During Atraumatic Restorative Treatment in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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 ™.

Official Title
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Discomfort Evaluation During Atraumatic Restorative Treatment in Children- Clinical Trial

Conditions
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Dental Caries, Primary Teeth, Post Dental Restoration

Intervention / Treatment
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* Other: Caries removal using only manual instruments
* Other: Caries removal using Papacarie gel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atraumatic Restorative Treatment<br>Partial removal of carious tissue using manual instruments. | Other: Caries removal using only manual instruments<br>* Caries removal using only manual instruments according to Atraumatic Restorative Treatment<br>|
| Experimental: Chemo-mechanical Removal<br>Partial removal of carious tissue using manual instruments and the material Chemo-mechanical removal group using Papacarie™gel. | Other: Caries removal using Papacarie gel<br>* Caries removal using a chemical-mechanical method - Papacarie gel and manual instruments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | immediately after treatment | 
| Discomfort evaluation with heart beat and oxygen saturation |  | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of restorative procedure |  | 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 |  | immediately after treatment |