Discomfort Evaluation During Atraumatic Restorative Treatment in Children- Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dental Caries
- Sponsor
- Faculty Sao Leopoldo Mandic Campinas
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Discomfort evaluation with heart beat and oxygen saturation
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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 ™.
Investigators
Jose Carlos P Imparato
Principal Investigator
Faculty Sao Leopoldo Mandic Campinas
Eligibility Criteria
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,
- •swollen area around the tooth,
- •furcation,
- •cervical lesion,
- •restorations,
- •sealants,
- •developmental defect of enamel.
Outcomes
Primary Outcomes
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).
Discomfort evaluation with Wong-Baker
Time Frame: 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
Secondary Outcomes
- Operators satisfaction(immediately after treatment)
- 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 ™)