Dental Caries, Post Dental Restoration, Primary Teeth
Conditions
Brief summary
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
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 ™.
Interventions
OTHERCaries removal using only manual instruments
Caries removal using only manual instruments according to Atraumatic Restorative Treatment
OTHERCaries removal using Papacarie gel
Caries removal using a chemical-mechanical method - Papacarie gel and manual instruments.
Sponsors
Faculty Sao Leopoldo Mandic Campinas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 9 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discomfort evaluation with Wong-Baker | immediately after treatment | 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 |
| 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
| Measure | 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 |
Countries
Brazil
Outcome results
None listed