Public trial
RBR-2b2vvf5 Caries prevention around the orthodontic appliance
Date of registration: 08/23/2021 (mm/dd/yyyy)Last approval date : 08/23/2021 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
en
Effect of using low-viscosity resinous infiltrant (Icon®) to prevent carious lesions around orthodontic brackets: a randomized clinical study
pt-br
Efeito da utilização de infiltrante resinoso de baixa viscosidade (icon®) na prevenção de lesões cariosas ao redor de braquetes Ortodônticos: um estudo clínico randomizado
es
Effect of using low-viscosity resinous infiltrant (Icon®) to prevent carious lesions around orthodontic brackets: a randomized clinical study
Trial identification
- UTN code:
-
Public title:
en
Caries prevention around the orthodontic appliance
pt-br
Prevenção de cárie ao redor do aparelho ortodôntico
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Scientific acronym:
-
Public acronym:
-
Secondaries identifiers:
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81495617.3.0000.5374
Issuing authority: Órgão emissor: Plataforma Brasil
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2.541.091
Issuing authority: Órgão emissor: Comitê de Ética em Pesquisa da Faculdade São Leopoldo Mandic
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81495617.3.0000.5374
Sponsors
- Primary sponsor: São Leopoldo Mandic
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Secondary sponsor:
- Institution: São Leopoldo Mandic
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Supporting source:
- Institution: Centro Universitário de Patos
Health conditions
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Health conditions:
en
Tooth desmineralization, Dental Caries, white spot
pt-br
Desmineralização dentária, Cárie dentária, manchas brancas
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General descriptors for health conditions:
en
3745 Dental Caries
pt-br
3745 Cárie dentária
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Specific descriptors:
en
25151 Desmineralization
pt-br
25151 Desmineralização
en
3745 White stop
pt-br
3745 Mancha branca
Interventions
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Interventions:
en
96 hemi-arches of 23 participants were divided into two groups: Experimental group 1 (Group G1), treated with the Icon ® resinous infiltrate (DMG), applied to an upper hemi-arch and necessarily its lower contralateral and experimental group 2 (Group G2), called control, treated with a fluorine-free placebo agent (Listerine), applied to the two other hemi-arches, so each patient is his control. The study was divided into three phases: T0 (application of resinous infiltrant), T1 (six months after application) and T2 (one year after application).
pt-br
96 hemiarcadas de 23 participantes foram divididas em dois grupos: Grupo experimental 1 (Grupo G1), tratado com o Infiltrante resinoso Icon ® (DMG), aplicado em um hemi-arco superior e necessariamente seu contra-lateral inferior e grupo experimental 2 (Grupo G2), denominado controle, tratado com um agente placebo livre de flúor (Listerine), aplicado nos dois outros hemi-arcos, sendo portanto cada paciente controle dele mesmo. O estudo foi dividido em três fases: T0 (aplicação do infiltrante resinoso ), T1 (seis meses pós-aplicação) e T2 (um ano pós aplicação).
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Descriptors:
en
D003743 Dental Enamel
pt-br
D003743 Esmalte Dentário
Recruitment
- Study status: Data analysis completed
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Countries
- Brazil
- Date first enrollment: 04/01/2018 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 23 - 12 Y 20 Y -
Inclusion criteria:
en
Age between 12 and 20 years; incisors, canines and premolars present in the arch, all with a healthy buccal surface at the beginning of orthodontic treatment; ICDAS greater than 2; no history of previous orthodontic treatment.
pt-br
Idade entre 12 e 20 anos; incisivos, caninos e pré-molares presentes no arco, todos com superfície vestibular hígida no início do tratamento ortodôntico; ICDAS maior que 2; sem histórico de tratamento ortodôntico prévio.
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Exclusion criteria:
en
Abuse of any type of medication, alcohol, nicotine or other types of drugs; systemic, metabolic or mental illness; craniofacial syndrome, cleft lip and / or palate.
pt-br
Uso abusivo de qualquer tipo de medicamento, álcool, nicotina ou outros tipos de drogas; doença sistêmica, metabólica ou mental; síndrome craniofacial, fissura labial e / ou palatina.
Study type
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Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase Prevention Parallel 2 Single-blind Randomized-controlled N/A
Outcomes
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Primary outcomes:
en
Ability of the resinous infiltrant (Icon) to prevent the formation of a white spot lesion (tooth demineralization) obtained in scores (ordinal categorical variable with 7 categories), through the International Caries Detection and Assessment System (ICDAS), when compared to a group in which no intervention was performed (control group).
pt-br
Capacidade do infiltrante resinoso (Icon) impedir a formação de lesão de mancha branca (desmineralização dentária) obtida em escores (variável categórica ordinal com 7 categorias), através do índice International Caries Detection and Assessment System (ICDAS), when compared to a group in which no intervention was performed (control group).
en
Capacity of the resinous infiltrant (Icon) to prevent the formation of white spot lesions (dental demineralization) during one year of follow-up, obtained in scores (ordinal categorical variable with 7 categories), through the International Caries Detection and Assessment System index ( ICDAS), verified six months (T1) and one year (T2) after application of the resinous infiltrate (T0).
pt-br
Capacidade do infiltrante resinoso (Icon) manter-se impedido a formação de lesão de mancha branca (desmineralização dentária) durante um ano de acompanhamento, obtida em escores (variável categórica ordinal com 7 categorias), através do índice International Caries Detection and Assessment System (ICDAS), verificada seis meses (T1) e um ano (T2) após aplicação do infiltrante resinoso (T0).
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Secondary outcomes:
en
Secondary outcomes are not expected.
pt-br
Não são esperados desfechos secundários
en
Secondary outcomes are not expected.
pt-br
Não são esperados desfechos secundários.
Contacts
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Public contact
- Full name: Patricia Pereira Maciel
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- Address: Rua Francisco de Assis Silva, 03
- City: Nazarezinho / Brazil
- Zip code: 58817-000
- Phone: +5583981076153
- Email: patriciamaciel.p@hotmail.com
- Affiliation:
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Scientific contact
- Full name: Patricia Pereira Maciel
-
- Address: Rua Francisco de Assis Silva, 03
- City: Nazarezinho / Brazil
- Zip code: 58817-000
- Phone: +5583981076153
- Email: patriciamaciel.p@hotmail.com
- Affiliation:
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Site contact
- Full name: Patricia Pereira Maciel
-
- Address: Rua Francisco de Assis Silva, 03
- City: Nazarezinho / Brazil
- Zip code: 58817-000
- Phone: +5583981076153
- Email: patriciamaciel.p@hotmail.com
- Affiliation:
Additional links:
Total de Ensaios Clínicos 16962.
Existem 8358 ensaios clínicos registrados.
Existem 4701 ensaios clínicos recrutando.
Existem 239 ensaios clínicos em análise.
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