NCT03520309

Brief Summary

There is still great divergence in the aspects related to caries lesions around restorations. The methods and the systems used for the detection of secondary caries lesions have presented low validity. Also, the consequent treatment decisions of this kind of lesions have presented a lot of variation. However, the correct diagnosis of secondary caries may guarantee greater longevity to the restorative treatment, as well as oral health to the patients, reducing the cost and clinical time of the dentists. Therefore, the investigators aimed to perform this study to evaluate and compare two visual criteria for the evaluation of restorations in primary teeth in medium and long term outcomes for the patients, through a randomized clinical study. These criteria are the system proposed by the World Dental Federation (FDI) and the International Caries Classification and Management System - ICCMS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
163

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 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

Study Start

First participant enrolled

November 16, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 9, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

October 20, 2021

Status Verified

October 1, 2021

Enrollment Period

1 year

First QC Date

March 6, 2018

Last Update Submit

October 14, 2021

Conditions

Dental CariesSecondary Dental Caries

Keywords

DiagnosisVisual inspectionQuality of LifeRestorations

Outcome Measures

Primary Outcomes (1)

  • Restoration survival

    Major failures of restorations: restorations presenting failures that need replacement or teeth with pulp involvement, pain or that need extraction (except due to orthodontic reasons). For restorations involving occlusal surfaces, score 4 of Frencken et al. criteria (1996) will be considered. For restorations involving other surfaces, the scores 21, 30, and 40. The primary outcome was changed due to the COVID-19 pandemic situation. As we were not able to assess patients' restorations at 24 months, we could not evaluate the need for operative treatment at this time. Therefore, restoration survival was set as the primary outcome, as we can determine the restoration failure by the assessment date.

    24 months

Secondary Outcomes (5)

  • Operative treatment needs of the evaluated restorations (success of restoration)

    24 months.

  • Necessity to repair the restoration

    24 months.

  • Restoration replacement

    24 months.

  • Presence of secondary caries lesion with dentin exposure

    24 months.

  • Restored teeth that presents symptoms of pulp inflammation or episode of pain

    24 months.

Other Outcomes (2)

  • Impact of Oral Health on quality of life

    24 months

  • Cost of the treatments

    24 months

Study Arms (2)

International Dental Federation

EXPERIMENTAL

Dental Treatment: according to the decision based on the International Dental Federation (FDI) criteria

Procedure: Dental treatment

Caries Around Restorations System

EXPERIMENTAL

Dental Treatment: according to the decision based on the Caries Around Restorations System (CARS) and treatment decision proposed by the International Caries Classification and Management System (ICCMS)

Procedure: Dental treatment

Interventions

Dental treatmentPROCEDURE

Treatment of all dental restorations of the children according to the diagnosis criteria

Caries Around Restorations SystemInternational Dental Federation

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children who sought dental treatment in our dental school (School of Dentistry, University of Sao Paulo, Sao Paulo, Brazil)
  • Children aged 3 to 6 years
  • Children with at least one restoration on a primary tooth of any material, on any dental surface and regardless of its condition.

You may not qualify if:

  • Children whose parents refuse to participate of the research
  • Children who refuse to participate of the research or exhibited behavioral problems during the initial appointment
  • All child's restorations will be included in the evaluation, except for restorations presenting fistula, abscess, pulp exposure, history of spontaneous dental pain or mobility.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dentistry, University of Sao Paulo

São Paulo, 05508-000, Brazil

Location

Related Publications (9)

  • Ismail AI, Pitts NB, Tellez M; Authors of International Caries Classification and Management System (ICCMS); Banerjee A, Deery C, Douglas G, Eggertsson H, Ekstrand K, Ellwood R, Gomez J, Jablonski-Momeni A, Kolker J, Longbottom C, Manton D, Martignon S, McGrady M, Rechmann P, Ricketts D, Sohn W, Thompson V, Twetman S, Weyant R, Wolff M, Zandona A. The International Caries Classification and Management System (ICCMS) An Example of a Caries Management Pathway. BMC Oral Health. 2015;15 Suppl 1(Suppl 1):S9. doi: 10.1186/1472-6831-15-S1-S9. Epub 2015 Sep 15. No abstract available.

    PMID: 26391116BACKGROUND

  • Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation - clinical criteria for the evaluation of direct and indirect restorations. Update and clinical examples. J Adhes Dent. 2010 Aug;12(4):259-72. doi: 10.3290/j.jad.a19262.

    PMID: 20847997BACKGROUND

  • Martins-Junior PA, Ramos-Jorge J, Paiva SM, Marques LS, Ramos-Jorge ML. Validations of the Brazilian version of the Early Childhood Oral Health Impact Scale (ECOHIS). Cad Saude Publica. 2012 Feb;28(2):367-74. doi: 10.1590/s0102-311x2012000200015.

    PMID: 22331162BACKGROUND

  • Shivakumar K, Prasad S, Chandu G. International Caries Detection and Assessment System: A new paradigm in detection of dental caries. J Conserv Dent. 2009 Jan;12(1):10-6. doi: 10.4103/0972-0707.53335.

    PMID: 20379434BACKGROUND

  • Roeleveld AC, van Amerongen WE, Mandari GJ. Influence of residual caries and cervical gaps on the survival rate of Class II glass ionomer restorations. Eur Arch Paediatr Dent. 2006 Jun;7(2):85-91. doi: 10.1007/BF03320820.

    PMID: 17140533BACKGROUND

  • Olegario IC, Moro BLP, Tedesco TK, Freitas RD, Passaro AL, Garbim JR, Oliveira R, Mendes FM; CARDEC 03 collaborative group; Raggio DP. Use of rubber dam versus cotton roll isolation on composite resin restorations' survival in primary molars: 2-year results from a non-inferiority clinical trial. BMC Oral Health. 2022 Oct 10;22(1):440. doi: 10.1186/s12903-022-02449-y.

    PMID: 36217147DERIVED

  • Moro BLP, Pontes LRA, Maia HC, Freitas RD, Tedesco TK, Raggio DP, Braga MM, Ekstrand KR, Imparato JCP, Cenci MS, Mendes FM. Clinical Accuracy of Two Different Criteria for the Detection of Caries Lesions around Restorations in Primary Teeth. Caries Res. 2022;56(2):98-108. doi: 10.1159/000523951. Epub 2022 May 3.

    PMID: 35504257DERIVED

  • Freitas RD, Moro BLP, Pontes LRA, Maia HCM, Passaro AL, Oliveira RC, Garbim JR, Vigano MEF, Tedesco TK, Deery C, Raggio DP, Cenci MS, Mendes FM, Braga MM; CARDEC collaborative group - CARDEC-03 trial. The economic impact of two diagnostic strategies in the management of restorations in primary teeth: a health economic analysis plan for a trial-based economic evaluation. Trials. 2021 Nov 12;22(1):794. doi: 10.1186/s13063-021-05722-7.

    PMID: 34772437DERIVED

  • Moro BLP, Signori C, Freitas RD, Pontes LRA, Lenzi TL, Tedesco TK, Raggio DP, Braga MM, Ekstrand KR, Cenci MS, Mendes FM; CARDEC collaborative group; CaCIA collaborative group. The effect of two clinical criteria in the assessment of caries lesions around restorations in children (CARDEC-03): study protocol for a diagnostic randomized clinical trial. F1000Res. 2020 Jun 26;9:650. doi: 10.12688/f1000research.23801.3. eCollection 2020.

    PMID: 33520191DERIVED

MeSH Terms

Conditions

Dental CariesDisease

Interventions

Dental Care

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DentistryDental Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Fausto M Mendes, PhD

    School of Dentistry, University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 6, 2018

First Posted

May 9, 2018

Study Start

November 16, 2017

Primary Completion

November 30, 2018

Study Completion

September 15, 2021

Last Updated

October 20, 2021

Record last verified: 2021-10

Locations

BR(1)