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Completed

NCT Number: NCT03143387

Discomfort Evaluation During Atraumatic Restorative Treatment in Children

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.

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Key information

Conditions

Dental Caries Post Dental Restoration Primary Teeth Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

4 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculdade Sao Leopoldo Mandic

Campinas, São Paulo, 13045-755, Brazil

About this study

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 ™.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Caries removal using only manual instruments

Other

Caries removal using only manual instruments according to Atraumatic Restorative Treatment

Caries removal using Papacarie gel

Other

Caries removal using a chemical-mechanical method - Papacarie gel and manual instruments.

Primary outcomes

  1. 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

  2. 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).

Secondary outcomes

  1. Time of restorative procedure

    Time frame: Will be evaluated the time required for removal of the caries tissue only with manual removal and when manual removal with the product Papacárie ™

  2. Operators satisfaction

    Time frame: immediately after treatment

Sponsors and collaborators

Lead sponsor

Faculty Sao Leopoldo Mandic Campinas

Other

Registry information

Official study title

Discomfort Evaluation During Atraumatic Restorative Treatment in Children- Clinical Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 8, 2017
Registry last updated
Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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