Discomfort Evaluation During Atraumatic Restorative Treatment in Children

Faculty Sao Leopoldo Mandic Campinas

Status: Completed

Conditions: Post Dental Restoration; Dental Caries; Primary Teeth

Treatments: Other: Caries removal using only manual instruments; Other: Caries removal using Papacarie gel

Study type: Interventional

Funder types: Other

Identifiers

NCT03143387

ART discomfort

Details and patient eligibility

About

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.

Full 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 ™.

Enrollment: 40 patients

Sex: All

Ages: 4 to 9 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Atraumatic Restorative Treatment

Active Comparator group

Description:

Partial removal of carious tissue using manual instruments.

Treatment:

Other: Caries removal using only manual instruments

Chemo-mechanical Removal

Experimental group

Description:

Partial removal of carious tissue using manual instruments and the material Chemo-mechanical removal group using Papacarie™gel.

Treatment:

Other: Caries removal using Papacarie gel