NCT02377297

Brief Summary

The aim of this study is to evaluate the survival rate and the cost-effectiveness of occlusal-ART restorations using three GIC brands (Fuji IX, GC Europe; Maxxion R, FGM; Vitro Molar, DFL) in primary molars.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

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

First Submitted

Initial submission to the registry

October 14, 2014

Completed
18 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2018

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

October 14, 2014

Last Update Submit

May 22, 2020

Conditions

Dental Caries

Keywords

dental atraumatic restorative treatmentprimary toothocclusal restorationglass-ionomer cement

Outcome Measures

Primary Outcomes (1)

  • Survival rate occlusal restorations between the 3 groups

    The evaluation criteria will be that described by Roeleveld et al., 2006, in which scores 00 or 10 will be considered as success. On the other hand, scores 11, 12, 13, 20, 21, 30, 40 or 50 will considered as failure of the restoration. The remaining scores 60, 70 or 90 will not be considered as success or failure (censored data).

    Every 6 months up to 2 years

Secondary Outcomes (2)

  • Difference differents DMFTs between the patients and the sucess rate of the restoration

    After 2 years

  • Cost analysis between three groups

    Every 6 months up to 2 years

Study Arms (3)

Restoration with Fuji IX

ACTIVE COMPARATOR

The cavities will be restored with Fuji IX (GC Europe, Leuven, BE).

Procedure: Restoration with Fuji IX

Restoration with Vitro Molar

EXPERIMENTAL

The cavities will be restored with Vitro Molar (DHL, Rio de Janeiro, BR).

Procedure: Restoration with Vitro Molar

Restoration with Maxxion R

EXPERIMENTAL

The cavities will be restored with Maxxion R (FGM, Rio de Janeiro, BR).

Procedure: Restoration with Maxxion R

Interventions

Restoration with Fuji IXPROCEDURE

The cavities will be restored with Fuji IX (GC Europe, Leuven, BE).

Restoration with Fuji IX
Restoration with Vitro MolarPROCEDURE

The cavities will be restored with Vitro Molar (DHL, Rio de Janeiro, BR).

Restoration with Vitro Molar
Restoration with Maxxion RPROCEDURE

The cavities will be restored with Maxxion R (FGM, Rio de Janeiro, BR).

Restoration with Maxxion R

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • healthy
  • cooperative
  • at least one occlusal carious lesion in a primary molar
  • lesion extending to the dentin with dimensions not greater than 2 mm occluso-cervical
  • intact edge list
  • signed consent form from the responsible part

You may not qualify if:

  • the tooth cannot present ulcer, abscess, fistula, or pathological mobility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo

São Paulo, 05508-000, Brazil

Location

Related Publications (3)

  • Bonifacio CC, Hesse D, Raggio DP, Bonecker M, van Loveren C, van Amerongen WE. The effect of GIC-brand on the survival rate of proximal-ART restorations. Int J Paediatr Dent. 2013 Jul;23(4):251-8. doi: 10.1111/j.1365-263X.2012.01259.x. Epub 2012 Aug 14.

    PMID: 22891625BACKGROUND

  • Holmgren CJ, Roux D, Domejean S. Minimal intervention dentistry: part 5. Atraumatic restorative treatment (ART)--a minimum intervention and minimally invasive approach for the management of dental caries. Br Dent J. 2013 Jan;214(1):11-8. doi: 10.1038/sj.bdj.2012.1175.

    PMID: 23306489BACKGROUND

  • Olegario IC, Pacheco AL, de Araujo MP, Ladewig NM, Bonifacio CC, Imparato JC, Raggio DP. Low-cost GICs reduce survival rate in occlusal ART restorations in primary molars after one year: A RCT. J Dent. 2017 Feb;57:45-50. doi: 10.1016/j.jdent.2016.12.006. Epub 2016 Dec 9.

    PMID: 27956016RESULT

MeSH Terms

Conditions

Dental Caries

Interventions

fuji IX

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Daniela P Raggio, prof.

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor at Paediatric Dentistry

Study Record Dates

First Submitted

October 14, 2014

First Posted

March 3, 2015

Study Start

November 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 6, 2018

Last Updated

May 27, 2020

Record last verified: 2020-05

Locations

BR(1)