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Discomfort Evaluation During Atraumatic Restorative Treatment in Children

Primary Purpose

Dental Caries, Primary Teeth, Post Dental Restoration

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Caries removal using only manual instruments
Caries removal using Papacarie gel
Sponsored by
Faculty Sao Leopoldo Mandic Campinas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries

Eligibility Criteria

4 Years - 9 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Faculdade Sao Leopoldo Mandic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Atraumatic Restorative Treatment

Chemo-mechanical Removal

Arm Description

Partial removal of carious tissue using manual instruments.

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

Outcomes

Primary Outcome Measures

Discomfort evaluation with Wong-Baker
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

Secondary Outcome Measures

Time of restorative procedure
Operators satisfaction

Full Information

First Posted
February 21, 2017
Last Updated
December 21, 2018
Sponsor
Faculty Sao Leopoldo Mandic Campinas
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1. Study Identification

Unique Protocol Identification Number
NCT03143387
Brief Title
Discomfort Evaluation During Atraumatic Restorative Treatment in Children
Official Title
Discomfort Evaluation During Atraumatic Restorative Treatment in Children- Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
October 15, 2017 (Actual)
Study Completion Date
October 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculty Sao Leopoldo Mandic Campinas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 ™.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Primary Teeth, Post Dental Restoration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atraumatic Restorative Treatment
Arm Type
Active Comparator
Arm Description
Partial removal of carious tissue using manual instruments.
Arm Title
Chemo-mechanical Removal
Arm Type
Experimental
Arm Description
Partial removal of carious tissue using manual instruments and the material Chemo-mechanical removal group using Papacarie™gel.
Intervention Type
Other
Intervention Name(s)
Caries removal using only manual instruments
Intervention Description
Caries removal using only manual instruments according to Atraumatic Restorative Treatment
Intervention Type
Other
Intervention Name(s)
Caries removal using Papacarie gel
Intervention Description
Caries removal using a chemical-mechanical method - Papacarie gel and manual instruments.
Primary Outcome Measure Information:
Title
Discomfort evaluation with Wong-Baker
Description
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
Time Frame
immediately after treatment
Title
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 Outcome Measure Information:
Title
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 ™
Title
Operators satisfaction
Time Frame
immediately after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
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, fistula, swollen area around the tooth, furcation, cervical lesion, restorations, sealants, developmental defect of enamel.
Facility Information:
Facility Name
Faculdade Sao Leopoldo Mandic
City
Campinas
State/Province
SP
ZIP/Postal Code
13045-755
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
6590605
Citation
Berggren U, Meynert G. Dental fear and avoidance: causes, symptoms, and consequences. J Am Dent Assoc. 1984 Aug;109(2):247-51. doi: 10.14219/jada.archive.1984.0328.
Results Reference
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PubMed Identifier
21678665
Citation
Bussadori SK, Guedes CC, Bachiega JC, Santis TO, Motta LJ. Clinical and radiographic study of chemical-mechanical removal of caries using Papacarie: 24-month follow up. J Clin Pediatr Dent. 2011 Spring;35(3):251-4. doi: 10.17796/jcpd.35.3.75803m02524625h5.
Results Reference
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PubMed Identifier
23532809
Citation
Colares V, Franca C, Ferreira A, Amorim Filho HA, Oliveira MC. Dental anxiety and dental pain in 5- to 12-year-old children in Recife, Brazil. Eur Arch Paediatr Dent. 2013 Feb;14(1):15-9. doi: 10.1007/s40368-012-0001-8. Epub 2013 Jan 30.
Results Reference
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PubMed Identifier
24402057
Citation
Frencken JE, Holmgren CJ. Caries management through the Atraumatic Restorative Treatment (ART) approach and glass-ionomers: update 2013. Braz Oral Res. 2014;28:5-8. doi: 10.1590/S1806-83242013000600001. No abstract available.
Results Reference
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PubMed Identifier
22824915
Citation
Frencken JE, Leal SC, Navarro MF. Twenty-five-year atraumatic restorative treatment (ART) approach: a comprehensive overview. Clin Oral Investig. 2012 Oct;16(5):1337-46. doi: 10.1007/s00784-012-0783-4. Epub 2012 Jul 24.
Results Reference
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PubMed Identifier
25409545
Citation
Mattos-Silveira J, Floriano I, Ferreira FR, Vigano ME, Frizzo MA, Reyes A, Novaes TF, Moriyama CM, Raggio DP, Imparato JC, Mendes FM, Braga MM. New proposal of silver diamine fluoride use in arresting approximal caries: study protocol for a randomized controlled trial. Trials. 2014 Nov 19;15:448. doi: 10.1186/1745-6215-15-448.
Results Reference
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PubMed Identifier
26038668
Citation
Simon AK, Bhumika TV, Nair NS. Does atraumatic restorative treatment reduce dental anxiety in children? A systematic review and meta-analysis. Eur J Dent. 2015 Apr-Jun;9(2):304-309. doi: 10.4103/1305-7456.156841.
Results Reference
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PubMed Identifier
23635899
Citation
Staman NM, Townsend JA, Hagan JL. Observational study: discomfort following dental procedures for children. Pediatr Dent. 2013 Jan-Feb;35(1):52-4.
Results Reference
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PubMed Identifier
27095334
Citation
Soares FC, Lima RA, Santos Cda F, de Barros MV, Colares V. Predictors of dental anxiety in Brazilian 5-7years old children. Compr Psychiatry. 2016 May;67:46-53. doi: 10.1016/j.comppsych.2016.01.006. Epub 2016 Jan 21.
Results Reference
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PubMed Identifier
24155626
Citation
Venkataraghavan K, Kush A, Lakshminarayana C, Diwakar L, Ravikumar P, Patil S, Karthik S. Chemomechanical Caries Removal: A Review & Study of an Indigen-ously Developed Agent (Carie Care (TM) Gel) In Children. J Int Oral Health. 2013 Aug;5(4):84-90. Epub 2013 Aug 28.
Results Reference
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Discomfort Evaluation During Atraumatic Restorative Treatment in Children

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