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Occlusal ART Restorations in Primary Molars Using 3 Different GIC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02377297
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : May 27, 2020
Sponsor:
Collaborator:
Academic Centre for Dentistry in Amsterdam
Information provided by (Responsible Party):
Daniela Prócida Raggio, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Dental Caries Procedure: Restoration with Fuji IX Procedure: Restoration with Vitro Molar Procedure: Restoration with Maxxion R Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Survival Rate and Cost Effectiveness of Occlusal ART Restorations in Primary Molars Using 3 Different Glass Ionomers Cements - a Randomized Clinical Trial
Study Start Date : November 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 6, 2018

Arm Intervention/treatment
Active Comparator: Restoration with Fuji IX
The cavities will be restored with Fuji IX (GC Europe, Leuven, BE).
Procedure: Restoration with Fuji IX
The cavities will be restored with Fuji IX (GC Europe, Leuven, BE).

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

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




Primary Outcome Measures :
  1. Survival rate occlusal restorations between the 3 groups [ Time Frame: Every 6 months up to 2 years ]
    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).


Secondary Outcome Measures :
  1. Difference differents DMFTs between the patients and the sucess rate of the restoration [ Time Frame: After 2 years ]
    Analyse the difference differents DMFTs between the patients and the sucess rate of the restoration. If higher DMFT has some influence in the sucess of the restoration (poor hygiene or big cavities around)

  2. Cost analysis between three groups [ Time Frame: Every 6 months up to 2 years ]
    For cost evaluation, the time of each restorative session will be recorded by an external researcher. All costs, subdivided into materials and professionals costs, measured in Brazilian real and converted to US Dollar (1.0 R$= 0.25U$ dollar) will be considered to analyze baseline cost and an estimation will be done for treatments' cumulative cost.



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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377297


Locations
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Brazil
University of Sao Paulo
Sao Paulo, Brazil, 05508-000
Sponsors and Collaborators
University of Sao Paulo
Academic Centre for Dentistry in Amsterdam
Investigators
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Principal Investigator: Daniela P Raggio, prof. University of Sao Paulo
Publications of Results:
Other Publications:
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Responsible Party: Daniela Prócida Raggio, Associated Professor at Paediatric Dentistry, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02377297    
Other Study ID Numbers: USPOART2014
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Keywords provided by Daniela Prócida Raggio, University of Sao Paulo:
dental atraumatic restorative treatment
primary tooth
occlusal restoration
glass-ionomer cement
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases