Hall Technique for the management of hypomineralized first permanent molars: A protocol of a randomized controlled trial with 3-year follow-up

Detalhes bibliográficos
Autor(a) principal: Guerra, Bianca Mattos dos Santos
Data de Publicação: 2024
Outros Autores: Jorge, Roberta Costa, Reis, Patrícia Papoula Gorni dos, Bonifácio, Clarissa Calil, Hesse, Daniela, Fidalgo, Tatiana Kelly da Silva, Soviero, Vera Mendes
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Research, Society and Development
Texto Completo: https://rsdjournal.org/index.php/rsd/article/view/45066
Resumo: The aim of this clinical protocol is to describe the methodology for the evaluation of the clinical performance of Hall Technique (HT) in comparison with glass ionomer cement (GIC) restorations in first permanent molars (FPM) severely affected by molar incisor hypomineralization (MIH). This protocol is related to a two-arm, parallel group, controlled and randomized superiority trial. It will be included 92 participants, 6 to 12 years-old, presenting at least one FPM with post-eruptive enamel breakdown and/or atypical caries and/or unsatisfactory atypical restoration involving cusp and extending to at least two tooth surfaces. Two trained and calibrated dentists will select the participants and assess the outcomes. Eight experienced clinicians who work as dentists at the public oral health system will be trained to perform the interventions. The participants will be randomized into the test (HT) or the control group (GIC). The outcomes will be assessed every 6 months up to 3 years. The primary outcome is the survival rate of the restorations. Secondary outcomes include satisfaction of the participants, parents, and dentists; impact on oral heath related quality of life; self-reported discomfort during treatment; signs/symptoms of temporomandibular joint dysfunction; and cost-effectiveness. Kaplan-Meier and Cox regression analysis will be used to analyze the primary outcome. Mann-Whitney or t-test will be used to compare the secondary outcomes between groups. We expect to provide scientific evidence about the treatment approach that maximizes success rates and minimizes retreatments in severe HMI.
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spelling Hall Technique for the management of hypomineralized first permanent molars: A protocol of a randomized controlled trial with 3-year follow-upHall Technique para el manejo de hipomineralización molar incisivo: Um protocolo de ensayo clínico aleatório con 3 años de seguimientoHall Technique para o manejo da hipomineralização molar incisivo: Um protocolo de um ensaio clínico randomizado com 3 anos de acompanhamento Hipomineralização de incisivos molaresHall TechniqueCoroa em aço inoxidávelCimento de ionômero de vidroMolar permanente.Molar incisor hypomineralizationHall techniqueStainless-steel crownGlass ionomer cementPermanent molar.Hipomineralización de incisivos molaresHall TechniqueCorona de acero inoxidableCemento de ionómero de vidrioMolar permanente.The aim of this clinical protocol is to describe the methodology for the evaluation of the clinical performance of Hall Technique (HT) in comparison with glass ionomer cement (GIC) restorations in first permanent molars (FPM) severely affected by molar incisor hypomineralization (MIH). This protocol is related to a two-arm, parallel group, controlled and randomized superiority trial. It will be included 92 participants, 6 to 12 years-old, presenting at least one FPM with post-eruptive enamel breakdown and/or atypical caries and/or unsatisfactory atypical restoration involving cusp and extending to at least two tooth surfaces. Two trained and calibrated dentists will select the participants and assess the outcomes. Eight experienced clinicians who work as dentists at the public oral health system will be trained to perform the interventions. The participants will be randomized into the test (HT) or the control group (GIC). The outcomes will be assessed every 6 months up to 3 years. The primary outcome is the survival rate of the restorations. Secondary outcomes include satisfaction of the participants, parents, and dentists; impact on oral heath related quality of life; self-reported discomfort during treatment; signs/symptoms of temporomandibular joint dysfunction; and cost-effectiveness. Kaplan-Meier and Cox regression analysis will be used to analyze the primary outcome. Mann-Whitney or t-test will be used to compare the secondary outcomes between groups. We expect to provide scientific evidence about the treatment approach that maximizes success rates and minimizes retreatments in severe HMI.El objetivo de este protocolo es describir la metodología para la evaluación de la Hall Technique (HT) en comparación con ionómero de vidrio (IV) en el tratamiento de los primeros molares permanentes (PMP) gravemente afectados por la hipomineralización molar incisiva (HMI). Se trata de un estudio de superioridad de dos brazos, aleatorizado, controlado. Se necesitarán 92 participantes, 6-12 años, con al menos un PMP con fractura post-eruptiva y/o caries atípica y/o restauración atípica insatisfactoria que involucre cúspide y se extienda, al menos, dos superficies dentales. Dos dentistas entrenadas y calibradas realizarán la selección de los participantes y la evaluación de los resultados. Ocho dentistas experimentados que trabajan en la red pública de salud bucal serán entrenados para realizar las intervenciones. Los participantes serán aleatorizados al grupo de prueba (HT) o control (IV). Los resultados serán evaluados semestralmente durante 3 años. El resultado primario es la tasa de supervivencia de las restauraciones. Los resultados secundarios incluyen la satisfacción de los participantes/padres/dentistas; impacto en la calidad de vida relacionada con la salud bucal; malestar autorreferido durante el tratamiento; signos/síntomas de disfunción de la articulación temporomandibular; y costo-efectividad. El análisis de Kaplan-Meier y la regresión de Cox se utilizarán para analizar el resultado primario. Dependiendo del patrón de distribución de los datos, se utilizará Mann-Whitney o prueba-t para comparar los resultados secundarios entre los grupos. Se espera que el ensayo clínico proporcione evidencia científica sobre el enfoque de tratamiento para la HMI grave que maximice las tasas de éxito y minimice los retratamientos.O objetivo deste protocolo é descrever a metodologia para avaliação do desempenho da Hall Technique (HT) em comparação com restaurações de cimento ionômero de vidro (CIV) no tratamento de primeiros molares permanentes (PMP) gravemente afetados pela hipomineralização molar incisivo (HMI). Trata-se de um estudo de superioridade de dois braços, randomizado e controlado. Serão necessários 92 participantes, sendo elegíveis, escolares entre 6 e 12 anos, com pelo menos um PMP com fratura pós-eruptiva e/ou cárie atípica e/ou restauração atípica insatisfatória envolvendo cúspide e estendendo-se a, pelo menos, duas superfícies dentárias. Duas dentistas treinadas e calibradas realizarão a seleção dos participantes e a avaliação dos desfechos. Oito dentistas experientes que atuam na rede pública de saúde bucal serão treinados para realizar as intervenções. os participantes serão randomizados para o grupo teste (HT) ou controle (CIV). Os desfechos serão avaliados semestralmente por 3 anos. O desfecho primário é a taxa de sobrevivência das restaurações. Os desfechos secundários incluem satisfação dos participantes, pais e dentistas; impacto na qualidade de vida relacionada à saúde bucal; desconforto autorreferido durante o tratamento; sinais/sintomas de disfunção da articulação temporomandibular; e custo-efetividade. A análise de Kaplan-Meier e regressão de Cox serão utilizadas para analisar o desfecho primário. Dependendo do padrão de distribuição dos dados, o teste Mann-Whitney ou teste-t será utilizado para comparar os desfechos secundários entre os grupos. A expectativa é que o ensaio clínico forneça evidências científicas sobre a abordagem de tratamento para a HMI grave que maximize as taxas de sucesso e minimize os retratamentos.Research, Society and Development2024-03-07info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://rsdjournal.org/index.php/rsd/article/view/4506610.33448/rsd-v13i3.45066Research, Society and Development; Vol. 13 No. 3; e1313345066Research, Society and Development; Vol. 13 Núm. 3; e1313345066Research, Society and Development; v. 13 n. 3; e13133450662525-3409reponame:Research, Society and Developmentinstname:Universidade Federal de Itajubá (UNIFEI)instacron:UNIFEIenghttps://rsdjournal.org/index.php/rsd/article/view/45066/36059Copyright (c) 2024 Bianca Mattos dos Santos Guerra; Roberta Costa Jorge; Patrícia Papoula Gorni dos Reis; Clarissa Calil Bonifácio; Daniela Hesse; Tatiana Kelly da Silva Fidalgo; Vera Mendes Sovierohttps://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessGuerra, Bianca Mattos dos Santos Jorge, Roberta Costa Reis, Patrícia Papoula Gorni dos Bonifácio, Clarissa Calil Hesse, Daniela Fidalgo, Tatiana Kelly da Silva Soviero, Vera Mendes 2024-04-04T18:36:46Zoai:ojs.pkp.sfu.ca:article/45066Revistahttps://rsdjournal.org/index.php/rsd/indexPUBhttps://rsdjournal.org/index.php/rsd/oairsd.articles@gmail.com2525-34092525-3409opendoar:2024-04-04T18:36:46Research, Society and Development - Universidade Federal de Itajubá (UNIFEI)false
dc.title.none.fl_str_mv Hall Technique for the management of hypomineralized first permanent molars: A protocol of a randomized controlled trial with 3-year follow-up
Hall Technique para el manejo de hipomineralización molar incisivo: Um protocolo de ensayo clínico aleatório con 3 años de seguimiento
Hall Technique para o manejo da hipomineralização molar incisivo: Um protocolo de um ensaio clínico randomizado com 3 anos de acompanhamento
title Hall Technique for the management of hypomineralized first permanent molars: A protocol of a randomized controlled trial with 3-year follow-up
spellingShingle Hall Technique for the management of hypomineralized first permanent molars: A protocol of a randomized controlled trial with 3-year follow-up
Guerra, Bianca Mattos dos Santos
Hipomineralização de incisivos molares
Hall Technique
Coroa em aço inoxidável
Cimento de ionômero de vidro
Molar permanente.
Molar incisor hypomineralization
Hall technique
Stainless-steel crown
Glass ionomer cement
Permanent molar.
Hipomineralización de incisivos molares
Hall Technique
Corona de acero inoxidable
Cemento de ionómero de vidrio
Molar permanente.
title_short Hall Technique for the management of hypomineralized first permanent molars: A protocol of a randomized controlled trial with 3-year follow-up
title_full Hall Technique for the management of hypomineralized first permanent molars: A protocol of a randomized controlled trial with 3-year follow-up
title_fullStr Hall Technique for the management of hypomineralized first permanent molars: A protocol of a randomized controlled trial with 3-year follow-up
title_full_unstemmed Hall Technique for the management of hypomineralized first permanent molars: A protocol of a randomized controlled trial with 3-year follow-up
title_sort Hall Technique for the management of hypomineralized first permanent molars: A protocol of a randomized controlled trial with 3-year follow-up
author Guerra, Bianca Mattos dos Santos
author_facet Guerra, Bianca Mattos dos Santos
Jorge, Roberta Costa
Reis, Patrícia Papoula Gorni dos
Bonifácio, Clarissa Calil
Hesse, Daniela
Fidalgo, Tatiana Kelly da Silva
Soviero, Vera Mendes
author_role author
author2 Jorge, Roberta Costa
Reis, Patrícia Papoula Gorni dos
Bonifácio, Clarissa Calil
Hesse, Daniela
Fidalgo, Tatiana Kelly da Silva
Soviero, Vera Mendes
author2_role author
author
author
author
author
author
dc.contributor.author.fl_str_mv Guerra, Bianca Mattos dos Santos
Jorge, Roberta Costa
Reis, Patrícia Papoula Gorni dos
Bonifácio, Clarissa Calil
Hesse, Daniela
Fidalgo, Tatiana Kelly da Silva
Soviero, Vera Mendes
dc.subject.por.fl_str_mv Hipomineralização de incisivos molares
Hall Technique
Coroa em aço inoxidável
Cimento de ionômero de vidro
Molar permanente.
Molar incisor hypomineralization
Hall technique
Stainless-steel crown
Glass ionomer cement
Permanent molar.
Hipomineralización de incisivos molares
Hall Technique
Corona de acero inoxidable
Cemento de ionómero de vidrio
Molar permanente.
topic Hipomineralização de incisivos molares
Hall Technique
Coroa em aço inoxidável
Cimento de ionômero de vidro
Molar permanente.
Molar incisor hypomineralization
Hall technique
Stainless-steel crown
Glass ionomer cement
Permanent molar.
Hipomineralización de incisivos molares
Hall Technique
Corona de acero inoxidable
Cemento de ionómero de vidrio
Molar permanente.
description The aim of this clinical protocol is to describe the methodology for the evaluation of the clinical performance of Hall Technique (HT) in comparison with glass ionomer cement (GIC) restorations in first permanent molars (FPM) severely affected by molar incisor hypomineralization (MIH). This protocol is related to a two-arm, parallel group, controlled and randomized superiority trial. It will be included 92 participants, 6 to 12 years-old, presenting at least one FPM with post-eruptive enamel breakdown and/or atypical caries and/or unsatisfactory atypical restoration involving cusp and extending to at least two tooth surfaces. Two trained and calibrated dentists will select the participants and assess the outcomes. Eight experienced clinicians who work as dentists at the public oral health system will be trained to perform the interventions. The participants will be randomized into the test (HT) or the control group (GIC). The outcomes will be assessed every 6 months up to 3 years. The primary outcome is the survival rate of the restorations. Secondary outcomes include satisfaction of the participants, parents, and dentists; impact on oral heath related quality of life; self-reported discomfort during treatment; signs/symptoms of temporomandibular joint dysfunction; and cost-effectiveness. Kaplan-Meier and Cox regression analysis will be used to analyze the primary outcome. Mann-Whitney or t-test will be used to compare the secondary outcomes between groups. We expect to provide scientific evidence about the treatment approach that maximizes success rates and minimizes retreatments in severe HMI.
publishDate 2024
dc.date.none.fl_str_mv 2024-03-07
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://rsdjournal.org/index.php/rsd/article/view/45066
10.33448/rsd-v13i3.45066
url https://rsdjournal.org/index.php/rsd/article/view/45066
identifier_str_mv 10.33448/rsd-v13i3.45066
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv https://rsdjournal.org/index.php/rsd/article/view/45066/36059
dc.rights.driver.fl_str_mv https://creativecommons.org/licenses/by/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Research, Society and Development
publisher.none.fl_str_mv Research, Society and Development
dc.source.none.fl_str_mv Research, Society and Development; Vol. 13 No. 3; e1313345066
Research, Society and Development; Vol. 13 Núm. 3; e1313345066
Research, Society and Development; v. 13 n. 3; e1313345066
2525-3409
reponame:Research, Society and Development
instname:Universidade Federal de Itajubá (UNIFEI)
instacron:UNIFEI
instname_str Universidade Federal de Itajubá (UNIFEI)
instacron_str UNIFEI
institution UNIFEI
reponame_str Research, Society and Development
collection Research, Society and Development
repository.name.fl_str_mv Research, Society and Development - Universidade Federal de Itajubá (UNIFEI)
repository.mail.fl_str_mv rsd.articles@gmail.com
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