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. |
Register:
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REBEC |
Last refreshed on:
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29 May 2023 |
Main ID: |
RBR-989h4f |
Date of registration:
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19/06/2018 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Clinical evaluation of restorations of posterior teeth using different types of composite resins
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Scientific title:
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Evaluation of admira fusion vs admira fusion xtra resins in posterior teeth restorations: randomized double-blind clinical trial |
Date of first enrolment:
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01/07/2015 |
Target sample size:
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Recruitment status: |
Data analysis completed |
URL:
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http://ensaiosclinicos.gov.br/rg/RBR-989h4f |
Study type:
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Intervention |
Study design:
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Treatment clinical trial, randomized-controlled, parallel, double-blind, two-arm
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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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Carlos Rocha Gomes
Torres |
Address:
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Av. Eng. Francisco José Longo, 777, Jardim São Dimas
12245000
São José dos Campos
Brazil |
Telephone:
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+551239479376 |
Email:
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carlos.rgt@ict.unesp.br |
Affiliation:
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Instituto de Ciência e Tecnologia da Universidade Estadual Paulista de São José dos Campos |
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Name:
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Carlos Rocha Gomes
Torres |
Address:
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Av. Eng. Francisco José Longo, 777, Jardim São Dimas
12245000
São José dos Campos
Brazil |
Telephone:
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+551239479376 |
Email:
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carlos.rgt@ict.unesp.br |
Affiliation:
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Instituto de Ciência e Tecnologia da Universidade Estadual Paulista de São José dos Campos |
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Key inclusion & exclusion criteria
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Inclusion criteria: Presence of cavities, fractures or cosmetic demands; first or second molars and permanent premolars needing restorations; should be performed at least two Class II restorations in each patient (the number of restorations of each material should be equal in each patient); presence of the antagonist and the adjacent tooth making contact; pulp vitalized and absence of painful symptoms; teeth that have never been subjected to direct pulp capping; no history of hypersensitivity in the teeth to be restored; size of the isthmus with no more than 2/3 of the intercuspal distance; permanent dentition.
Exclusion criteria: Presence of deleterious habits and bruxism; bad oral health and presence of periodontal disease; patients who are suffering from severe systemic diseases or allergies.
Age minimum:
18Y
Age maximum:
80Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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C07.793.221
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C07.793.720.210
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Dental caries, dental leakage
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Intervention(s)
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D05.750.716.822.308
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In this split-mouth study, each patient will receive two direct restorations made with two different composite resins, which will be divided into two groups: Control group - 30 patients will receive direct restorations in a posterior (molar or pre-molar) class I or II with composite resin Admira Fusion (Voco - Germany) by conventional tchnique; Experimental group: the same 30 patients will receive in another posterior tooth (molar or premolar) another direct restoration class I or II with the composite resin by bulk fill technique with Admira Fusion Xtra (Voco - Germany). The restorations will be allocated randomly for each tooth. Evaluations will be performed in the periods after 6, 12 and 24 months from the restorative procedure.
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E06.323.428
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Procedure/surgery
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Primary Outcome(s)
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Clinical success rate after 24 months, evaluated by tactile and visual examination by clinical exam, given in percentage.
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The success rate after 24 months for restorations with Admira Fusion composite resin was 100% and Admira Fusion Xtra was 96.15%. This difference was not significant.
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Secondary Outcome(s)
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Time necessary to perform the restoration with a timer, given in seconds.
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The time necessary to apply the restorative material, make the sculpture, light-cure the increments and complete the restoration was higher for Admira Fusion than Admira Fusion Xtra. The results of t-test for independent samples showed significant differences between the groups.
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Source(s) of Monetary Support
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Voco do Brasil Ltda
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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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