NCT03143387

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
24 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2017

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
Last Updated

December 24, 2018

Status Verified

December 1, 2018

Enrollment Period

5 months

First QC Date

February 21, 2017

Last Update Submit

December 21, 2018

Conditions

Dental CariesPrimary TeethPost Dental Restoration

Outcome Measures

Primary Outcomes (2)

  • 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

    immediately after treatment

  • 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 Outcomes (2)

  • 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 ™

  • Operators satisfaction

    immediately after treatment

Study Arms (2)

Atraumatic Restorative Treatment

ACTIVE COMPARATOR

Partial removal of carious tissue using manual instruments.

Other: Caries removal using only manual instruments

Chemo-mechanical Removal

EXPERIMENTAL

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

Other: Caries removal using Papacarie gel

Interventions

Caries removal using only manual instrumentsOTHER

Caries removal using only manual instruments according to Atraumatic Restorative Treatment

Atraumatic Restorative Treatment
Caries removal using Papacarie gelOTHER

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

Chemo-mechanical Removal

Eligibility Criteria

Age4 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • pulp exposition,
  • spontaneous pain,
  • mobility,
  • fistula,
  • swollen area around the tooth,
  • furcation,
  • cervical lesion,
  • restorations,
  • sealants,
  • developmental defect of enamel.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade Sao Leopoldo Mandic

Campinas, São Paulo, 13045-755, Brazil

Location

Related Publications (10)

  • 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.

    PMID: 6590605BACKGROUND

  • 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.

    PMID: 21678665BACKGROUND

  • 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.

    PMID: 23532809BACKGROUND

  • 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.

    PMID: 24402057BACKGROUND

  • 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.

    PMID: 22824915BACKGROUND

  • 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.

    PMID: 25409545BACKGROUND

  • 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.

    PMID: 26038668BACKGROUND

  • Staman NM, Townsend JA, Hagan JL. Observational study: discomfort following dental procedures for children. Pediatr Dent. 2013 Jan-Feb;35(1):52-4.

    PMID: 23635899BACKGROUND

  • 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.

    PMID: 27095334BACKGROUND

  • 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.

    PMID: 24155626BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 21, 2017

First Posted

May 8, 2017

Study Start

June 1, 2017

Primary Completion

October 15, 2017

Study Completion

October 30, 2017

Last Updated

December 24, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)