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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
RBR-8sw24r |
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Date of registration:
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12/07/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of a Restoarative Cement recommended for Atraumatic Restorative Treatment (ART) and a Composite resin in primary molars:
Clinical Trial
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Scientific title:
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Evaluation of a Glass Ionomer Cement recommended for ART and a Nanofilled Composite resin in primary molars:
Randomized Clinical Trial
- ART: Atraumatic Restorative Cement |
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Date of first enrolment:
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23/09/2013 |
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Target sample size:
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Recruitment status: |
Recruitment completed |
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URL:
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http://ensaiosclinicos.gov.br/rg/RBR-8sw24r |
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Study type:
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Intervention |
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Study design:
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Treatment Clinical trial, paralel, opened, randomized controlled with two arms.
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Juliana Ignácio Borges
Issa |
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Address:
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Rua Luís Antonio Adani 123
13148243
Paulínia
Brazil |
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Telephone:
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+551932536152 |
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Email:
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julianaib@hotmail.com |
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Affiliation:
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Centro de Pesquisas Odontológicas São Leopoldo Mandic |
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Name:
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José Carlos Petorrossi
Imparato |
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Address:
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Avenida Professor Lineu Prestes
05508-000
2227
Brazil |
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Telephone:
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+5511998686008 |
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Email:
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jimparato@usp.br |
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Affiliation:
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Centro de Pesquisas Odontológicas São Leopoldo Mandic |
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Key inclusion & exclusion criteria
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Inclusion criteria: age between 7 and 10 years old;presence of occlusal-proximal cavities in deciduous molars with isthmus between 1 and 3.0 mm and a depth less than 2.5 mm at the deepest point of the cavity.
Exclusion criteria: deficient restorations;pulp exposure;pain;history of fistula;tooth mobility;cavities smaller than 1mm and proximal atypical cavities (larger than 3mm) and deeper than 2.5mm
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Dental Caries
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C07.793.720.210
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Intervention(s)
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D05.750.716.822.308
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E06.070
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D25.339.291.402
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Procedure/surgery
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Radiation
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A total of 43 children were selected and the patients were allocated into two intervention groups: glass ionomer cement (Vitromolar A ART) and Composite nanoparticulate resin (Filtek Z350). All restorations were performed according to the principles of Atraumatic Restorative Treatment (ART).
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Primary Outcome(s)
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The primary outcome of this study was to evaluate the longevity of ART restorations in occlusal-proximal cavities of primary molars, using two restorative materials: glass ionomer cement and nanoparticulate composite resin.
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Secondary Outcome(s)
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To evaluate if other variables such as volume of the cavity, side, molar (1st or 2nd molar), gender may interfere in the longevity of the treatment.
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Source(s) of Monetary Support
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Centro de Pesquisas Odontológicas São Leopoldo Mandic
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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