Hall Technique for the management of hypomineralized first permanent molars: A protocol of a randomized controlled trial with 3-year follow-up
Autor(a) principal: | |
---|---|
Data de Publicação: | 2024 |
Outros Autores: | , , , , , |
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. |
id |
UNIFEI_788f0b75eb3c2b226fc90d1096772207 |
---|---|
oai_identifier_str |
oai:ojs.pkp.sfu.ca:article/45066 |
network_acronym_str |
UNIFEI |
network_name_str |
Research, Society and Development |
repository_id_str |
|
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 |
_version_ |
1797052638224711680 |