Public trial
RBR-8x8pf6d 3D digital analysis of dental arches before and after surgery in patients with unilateral and bilateral cleft lip and pa...
Date of registration: 06/30/2023 (mm/dd/yyyy)Last approval date : 06/30/2023 (mm/dd/yyyy)
Study type:
Observational
Scientific title:
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Use of 3D Sterephotogrammetry for volumetric analysis and image superimposition of the dental arches before and after surgeries in patients with unilateral and bilateral cleft lip and palate
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Uso da Esterefotogrametria 3D para análises volumétricas e sobreposição de imagens dos arcos dentários pré e pós-cirurgias de pacientes com fissura labiopalatina unilateral e bilateral
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Use of 3D Sterephotogrammetry for volumetric analysis and image superimposition of the dental arches before and after surgeries in patients with unilateral and bilateral cleft lip and palate
Trial identification
- UTN code: U1111-1292-8234
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Public title:
en
3D digital analysis of dental arches before and after surgery in patients with unilateral and bilateral cleft lip and palate
pt-br
Análise digital 3D dos arcos dentários pré e pós-cirurgias de pacientes com fissura labiopalatina unilateral e bilateral
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Scientific acronym:
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Public acronym:
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Secondaries identifiers:
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77285417.0.0000.5417
Issuing authority: Plataforma Brasil
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4.658.281
Issuing authority: Comitê de Ética em Pesquisa da Universidade de São Paulo
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77285417.0.0000.5417
Sponsors
- Primary sponsor: Universidade de São Paulo
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Secondary sponsor:
- Institution: Universidade de São Paulo
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Supporting source:
- Institution: Fundação de Amparo a Pesquisa do Estado de São Paulo
Health conditions
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Health conditions:
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Cleft Palate
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Fissura Palatina
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General descriptors for health conditions:
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C05.500.460 Jaw Abnormalities
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C05.500.460 Anormalidades Maxilomandibulares
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Specific descriptors:
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C05.500.460.185 Cleft Palate
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C05.500.460.185 Fissura Palatina
Interventions
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Interventions:
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The objective of the retrospective observational study was to evaluate the dental arches of children with cleft lip and palate before and after plastic rehabilitation surgeries. Group of fisty six (56) participants with cleft lip and palate who were molded before and after plastic rehabilitative surgeries at University of São Paulo. Dental models were digitized by a scanner and measurements were performed using software. The dental arches were evaluated in three periods.
pt-br
O objetivo do estudo observacional retrospectivo foi avaliar os arcos dentários de crianças com fissura labiopalatina antes e após as cirurgias plásticas reabiltadoras. Grupo de cinquenta e seis (56) participantes com fissura labiopalatina que foram moldadados antes e após as cirurgias plásticas reabilitadoras na Universidade de São Paulo. Os modelos dentários foram digitalizados por um scanner e as medidas foram efetuadas por meio de um software. Os arcos dentários foram avaliados em três períodos.
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Descriptors:
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V03.175.500 Observational Study
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V03.175.500 Estudo Observacional
Recruitment
- Study status: Data analysis completed
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Countries
- Brazil
- Date first enrollment: 08/01/2018 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 56 - 0 0 -
Inclusion criteria:
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Participants with non-syndromic unilateral cleft lip and palate; all surgical procedures were performed by a single plastic surgeon; male and female genders
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Participantes com fissura labiopalatal unilateral não sindrômica; todos os procedimentos cirúrgicos realizados por um único cirurgião plástico; gêneros masculino e feminino
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Exclusion criteria:
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Poor quality dental models
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Modelos dentários de qualidade inadequada
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
Outcomes
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Primary outcomes:
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Expected outcome 1, it was expected that surgical techniques could influence the development of dental arches
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Desfecho esperado 1, Esperava-se que as técnicas cirúrgicas poderiam influenciar no desenvolvimento dos arcos dentários
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Outcome found 1, it was found that, regardless of the surgical techniques, the dental arches are influenced by the rehabilitation protocol
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Desfecho encontrado 1, encontrou-se que, independentemente das técnicas cirúrgicas, as arcadas dentárias são influenciadas pelo protocolo reabilitador
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Secondary outcomes:
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Secondary outcomes are not expected.
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Não são esperados desfechos secundários.
Contacts
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Public contact
- Full name: Eloá Cristina Passucci Ambrosio
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- Address: Doutor Octávio Pinheiro Brisolla 75 Quadra 9
- City: Bauru / Brazil
- Zip code: 17012-901
- Phone: +55(14)3235-8356
- Email: eloacpambrosio@usp.br
- Affiliation: Universidade de São Paulo
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Scientific contact
- Full name: Eloá Cristina Passucci Ambrosio
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- Address: Doutor Octávio Pinheiro Brisolla 75 Quadra 9
- City: Bauru / Brazil
- Zip code: 17012-901
- Phone: +55(14)3235-8356
- Email: eloacpambrosio@usp.br
- Affiliation: Universidade de São Paulo
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Site contact
- Full name: Eloá Cristina Passucci Ambrosio
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- Address: Doutor Octávio Pinheiro Brisolla 75 Quadra 9
- City: Bauru / Brazil
- Zip code: 17012-901
- Phone: +55(14)3235-8356
- Email: eloacpambrosio@usp.br
- Affiliation: Universidade de São Paulo
Additional links:
Total de Ensaios Clínicos 16960.
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