Discomfort Evaluation During Atraumatic Restorative Treatment in Children

December 21, 2018 updated by: Jose Carlos P Imparato, Faculty Sao Leopoldo Mandic Campinas

Discomfort Evaluation During Atraumatic Restorative Treatment in Children- Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Campinas, SP, Brazil, 13045-755
        • Faculdade Sao Leopoldo Mandic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 9 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Atraumatic Restorative Treatment
Partial removal of carious tissue using manual instruments.
Other: Caries removal using only manual instruments
Caries removal using only manual instruments according to Atraumatic Restorative Treatment
EXPERIMENTAL: Chemo-mechanical Removal
Partial removal of carious tissue using manual instruments and the material Chemo-mechanical removal group using Papacarie™gel.
Other: Caries removal using Papacarie gel
Caries removal using a chemical-mechanical method - Papacarie gel and manual instruments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
immediately after treatment
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).
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

Outcome Measure
Time Frame
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 ™
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
Time Frame: immediately after treatment
immediately after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculty Sao Leopoldo Mandic Campinas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2017

Primary Completion (ACTUAL)

October 15, 2017

Study Completion (ACTUAL)

October 30, 2017

Study Registration Dates

First Submitted

February 21, 2017

First Submitted That Met QC Criteria

May 3, 2017

First Posted (ACTUAL)

May 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 24, 2018

Last Update Submitted That Met QC Criteria

December 21, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ART discomfort

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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