Discomfort Evaluation During Atraumatic Restorative Treatment in Children

Not Applicable

Completed

• Conditions: Post Dental Restoration; Dental Caries; Primary Teeth
• Interventions: Other: Caries removal using only manual instruments; Other: Caries removal using Papacarie gel

• Registration Number: NCT03143387
• Lead Sponsor: Faculty Sao Leopoldo Mandic Campinas

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 ™.

Study Timeline

• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-08
• Study Start: 2017-06-01
• Primary Completion: 2017-10-15
• Study Completion: 2017-10-30
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-21
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atraumatic Restorative Treatment	Caries removal using only manual instruments	Partial removal of carious tissue using manual instruments.
Chemo-mechanical Removal	Caries removal using Papacarie gel	Partial removal of carious tissue using manual instruments and the material Chemo-mechanical removal group using Papacarie™gel.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 ™

Trial Locations

Locations (1)

Faculdade Sao Leopoldo Mandic; 🇧🇷 Campinas, SP, Brazil