Efetividade e custo-efetividade de três alternativas de tratamento para reabilitação do desdentado mandibular: ensaio clínico randomizado com acompanhamento de 1 ano

Detalhes bibliográficos
Ano de defesa: 2019
Autor(a) principal: Hartmann, Roberto lattes
Orientador(a): Leles, Cláudio Rodrigues lattes
Banca de defesa: Leles, Cláudio Rodrigues, Gonçalves, Thais Marques Simek Vega, Abreu, Mauro Henrique Nogueira Guimarães de, Ribeiro-Rotta, Rejane Faria, Nogueira, Túlio Eduardo
Tipo de documento: Tese
Tipo de acesso: Acesso aberto
Idioma: eng
Instituição de defesa: Universidade Federal de Goiás
Programa de Pós-Graduação: Programa de Pós-graduação em Odontologia (FO)
Departamento: Faculdade de Odontologia - FO (RG)
País: Brasil
Palavras-chave em Português:
Palavras-chave em Inglês:
Área do conhecimento CNPq:
Link de acesso: http://repositorio.bc.ufg.br/tede/handle/tede/10168
Resumo: This randomized trial compared the effectiveness and cost-effectiveness (cost x patient centered outcomes) of three treatment alternatives for mandibular edentulism rehabilitation: unit-implant-retained mandibular overdenture (Group I), two-implant-retained mandibular overdenture (Group II) and four-implant-supported mandibular fixed prosthesis (Group III). We included 50 fully edentulous patients who initially received new conventional total dentures (baseline) and were later randomly allocated to one of the treatment groups. External hexagon implants (Titamax TI Cortical, Neodent, Curitiba, Brazil) were installed following the conventional loading installation protocol. Generalized Estimating Equations (GEE) was used to calculate the primary outcome variables were the direct dental costs which were identified, measured and valued; oral health-related quality of life (OHIP-Edent) and patient satisfaction with prostheses in all groups for a follow-up period of 1 year. Masticatory performance, prosthetic complications, maintenance events and peri-implant evaluation (marginal bone loss, peri-implant tissue status, implant stability quotient - ISQ) were evaluated as secondary outcomes. Data from 37 participants: Group I (n = 11); Group II (n = 13); Group III (n = 13) were collected and were similar in relation to baseline clinical characteristics and outcomes of initial treatment with conventional full dentures. Incremental cost-effectiveness - ICER ranged for Group II (compared to Group I) from R$ 36.20 to R$ 81.46 for a 1-point increase in patient satisfaction (base value = R$ 54.30) for Group III (compared to Group I) ranged from R$ 1321.12 to R$ 2972.52 (base value = R$ 1981.68). The total cost of treatment for the surgical and prosthetic phases was R$ 2,370.70 for Group I, R$ 3,185.20 for Group II and R$ 5,739.50 for Group III. There was a significant difference between the costs in the three groups (p <0.001). The greatest impacts on total treatment cost were related to the initial laboratory, implant and component costs in Group III. The satisfaction questionnaires and OHIP-Edent satisfaction scores in the 12 months improved in all groups compared to baseline. and were similar in intergroup comparison at baseline (with new conventional full dentures) and 1 year after implant prosthesis capture. In intra- and inter-group comparisons there was no significant change regarding satisfaction with the maxillary prosthesis. Regarding masticatory performance, there was no difference between groups evaluated in the same period for the different cycles (20 and 50 cycles) with gradual improvement for all groups up to 6 months and a slight decrease in 12 months for all groups. It was concluded that the rehabilitation of edentulous patients with implants significantly improved patient-reported outcomes in all treatment groups. Regarding the economic aspects of the treatments, the direct dental cost and the clinical time spent to perform the treatment and follow-up during the 1 year period in the fixed prosthesis (Group III) was approximately three times higher than in Group I, which did not correspond to a proportional gain in effectiveness as well as the additional cost of overdenture retained by two implants did not result in significant effectiveness gain over overdenture retained per unit implant. The implant survival was 100% in all groups after the 1-year follow-up. Considering the limitations of the study, implant-retained overdentures were the most cost-effective modalities.
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spelling Leles, Cláudio Rodrigueshttp://lattes.cnpq.br/6740286066154410Schimmel, MartinLeles, Cláudio RodriguesGonçalves, Thais Marques Simek VegaAbreu, Mauro Henrique Nogueira Guimarães deRibeiro-Rotta, Rejane FariaNogueira, Túlio Eduardohttp://lattes.cnpq.br/5981857085438577Hartmann, Roberto2019-11-11T15:24:08Z2019-08-23HARTMANN, R. Efetividade e custo-efetividade de três alternativas de tratamento para reabilitação do desdentado mandibular: ensaio clínico randomizado com acompanhamento de 1 ano. 2019. 102 f. Tese (Doutorado em Odontologia) - Universidade Federal de Goiás, Goiânia, 2019.http://repositorio.bc.ufg.br/tede/handle/tede/10168This randomized trial compared the effectiveness and cost-effectiveness (cost x patient centered outcomes) of three treatment alternatives for mandibular edentulism rehabilitation: unit-implant-retained mandibular overdenture (Group I), two-implant-retained mandibular overdenture (Group II) and four-implant-supported mandibular fixed prosthesis (Group III). We included 50 fully edentulous patients who initially received new conventional total dentures (baseline) and were later randomly allocated to one of the treatment groups. External hexagon implants (Titamax TI Cortical, Neodent, Curitiba, Brazil) were installed following the conventional loading installation protocol. Generalized Estimating Equations (GEE) was used to calculate the primary outcome variables were the direct dental costs which were identified, measured and valued; oral health-related quality of life (OHIP-Edent) and patient satisfaction with prostheses in all groups for a follow-up period of 1 year. Masticatory performance, prosthetic complications, maintenance events and peri-implant evaluation (marginal bone loss, peri-implant tissue status, implant stability quotient - ISQ) were evaluated as secondary outcomes. Data from 37 participants: Group I (n = 11); Group II (n = 13); Group III (n = 13) were collected and were similar in relation to baseline clinical characteristics and outcomes of initial treatment with conventional full dentures. Incremental cost-effectiveness - ICER ranged for Group II (compared to Group I) from R$ 36.20 to R$ 81.46 for a 1-point increase in patient satisfaction (base value = R$ 54.30) for Group III (compared to Group I) ranged from R$ 1321.12 to R$ 2972.52 (base value = R$ 1981.68). The total cost of treatment for the surgical and prosthetic phases was R$ 2,370.70 for Group I, R$ 3,185.20 for Group II and R$ 5,739.50 for Group III. There was a significant difference between the costs in the three groups (p <0.001). The greatest impacts on total treatment cost were related to the initial laboratory, implant and component costs in Group III. The satisfaction questionnaires and OHIP-Edent satisfaction scores in the 12 months improved in all groups compared to baseline. and were similar in intergroup comparison at baseline (with new conventional full dentures) and 1 year after implant prosthesis capture. In intra- and inter-group comparisons there was no significant change regarding satisfaction with the maxillary prosthesis. Regarding masticatory performance, there was no difference between groups evaluated in the same period for the different cycles (20 and 50 cycles) with gradual improvement for all groups up to 6 months and a slight decrease in 12 months for all groups. It was concluded that the rehabilitation of edentulous patients with implants significantly improved patient-reported outcomes in all treatment groups. Regarding the economic aspects of the treatments, the direct dental cost and the clinical time spent to perform the treatment and follow-up during the 1 year period in the fixed prosthesis (Group III) was approximately three times higher than in Group I, which did not correspond to a proportional gain in effectiveness as well as the additional cost of overdenture retained by two implants did not result in significant effectiveness gain over overdenture retained per unit implant. The implant survival was 100% in all groups after the 1-year follow-up. Considering the limitations of the study, implant-retained overdentures were the most cost-effective modalities.Este ensaio clínico randomizado comparou a efetividade e o custo-efetividade (custo x desfecho centrado no paciente) de três alternativas de tratamento para a reabilitação do edentulismo mandibular: overdenture mandibular retida por implante unitário (Grupo I), overdenture mandibular retida por dois implantes (Grupo II) e prótese fixa mandibular suportada por quatro implantes (Grupo III). Foram incluídos 50 desdentados totais os quais receberam inicialmente novas próteses totais convencionais (baseline) sendo posteriormente,alocados aleatoriamente para um dos grupos de tratamento. Implantes do tipo hexágono externo (Titamax TI Cortical, Neodent, Curitiba, Brasil) foram instalados seguindo o protocolo de instalação para carga convencional. Equações de Estimações Generalizadas (GEE) foram utilizadas para variáveis de desfecho primário como os custos odontológicos diretos os quais foram identificados, mensurados e valorados; a qualidade de vida relacionada à saúde oral (OHIP-Edent) e a satisfação do paciente com as próteses, em todos os grupos por um período de acompanhamento de 1 ano. A performance mastigatória, complicações protéticas, eventos de manutenção e avaliação peri-implantar (perda óssea marginal, estabilidade dos tecidos peri-implantares, quociente de estabilidade implantar – ISQ) foram avaliadas como desfechos secundários. Dados de 37 participantes: Grupo I (n=11); Grupo II (n=13); Grupo III (n=13) foram coletados sendo semelhantes em relação às características clínicas basais e desfechos do tratamento inicial com prótese total convencional. O custo-efetividade incremental - ICER variou para o Grupo II (comparado ao Grupo I) de R$ 36,20 a R$ 81,46 para um incremento de 1 ponto na satisfação do paciente (valor base = R $ 54,30), para o Grupo III (comparado ao Grupo I) variou de R$ 1321,12 a R$ 2972,52 (valor base = R $ 1981,68). O custo total do tratamento referente as fases cirúrgica e protética foi de R$ 2.370,70 para o Grupo I, R$ 3.185,20 para o Grupo II e R$ 5.739,50 para o Grupo III. Houve diferença significativa entre os custos nos três grupos (p<0,001). Os maiores impactos no custo total do tratamento foram relacionados aos custos iniciais laboratoriais, de implantes e componentes no Grupo III. Os escores dos questionários de satisfação com as próteses mandibulares e de OHIP-Edent no periodo de 12 meses apresentaram melhora em todos grupos em relação ao baseline. e foram semelhantes na comparação inter-grupos no tempo inicial (com as próteses totais convencionais novas) e 1 ano após a captura das próteses sobre implantes. Nas comparações intra e inter grupos não houve alteração significativa em relação à satisfação com a prótese maxilar. Em relação à performance mastigatória não houve diferença inter-grupos avaliados no mesmo período para os diferentes ciclos (20 e 50 ciclos) com melhora gradativa para todos os grupos até o período de 6 meses e leve queda no período de 12 meses para todos os grupos. Concluiu-se que reabilitação de pacientes desdentados totais com implantes melhorou significativamente os desfechos reportados pelo paciente em todos os grupos de tratamento. Com relação aos aspectos econômicos dos tratamentos, o custo direto odontológico e o tempo clínico dispendido para a realização do tratamento e acompanhamento durante o período de 1 ano na prótese fixa (Grupo III) foi aproximadamente três vezes maior em relação ao Grupo I o que não correspondeu a um ganho proporcional de efetividade assim como o custo adicional da overdenture retida por dois implantes não resultou em ganho de efetividade significativo em relação à overdenture retida por implante unitário. A taxa de sobrevida do implante, após um ano de acompanhamento, foi de 100% para todos os grupos. Levando em consideração as limitações do estudo, as overdenture retidas por implantes se apresentaram como modalidades mais custo-efetiva.Submitted by Luciana Ferreira (lucgeral@gmail.com) on 2019-11-11T14:37:44Z No. of bitstreams: 2 Tese - Roberto Hartmann - 2019.pdf: 2709031 bytes, checksum: 83c7ab208554e65363d06cc23e86fc89 (MD5) license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5)Approved for entry into archive by Luciana Ferreira (lucgeral@gmail.com) on 2019-11-11T15:24:08Z (GMT) No. of bitstreams: 2 Tese - Roberto Hartmann - 2019.pdf: 2709031 bytes, checksum: 83c7ab208554e65363d06cc23e86fc89 (MD5) license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5)Made available in DSpace on 2019-11-11T15:24:08Z (GMT). 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dc.title.eng.fl_str_mv Efetividade e custo-efetividade de três alternativas de tratamento para reabilitação do desdentado mandibular: ensaio clínico randomizado com acompanhamento de 1 ano
dc.title.alternative.eng.fl_str_mv Effectiveness and cost-effectiveness of three treatment alternatives for rehabilitation of the edentulous mandible: one- year randomized clinical trial
title Efetividade e custo-efetividade de três alternativas de tratamento para reabilitação do desdentado mandibular: ensaio clínico randomizado com acompanhamento de 1 ano
spellingShingle Efetividade e custo-efetividade de três alternativas de tratamento para reabilitação do desdentado mandibular: ensaio clínico randomizado com acompanhamento de 1 ano
Hartmann, Roberto
Implante dentário
Prótese dentária
Ensaio clínico randomizado
Análise de custo-efetividade
Desfechos de tratamento dental
Prosthodontics
Randomized clinical trial
Cost-effectiveness analysis
Treatment outcomes
Implant
CIENCIAS DA SAUDE::ODONTOLOGIA
title_short Efetividade e custo-efetividade de três alternativas de tratamento para reabilitação do desdentado mandibular: ensaio clínico randomizado com acompanhamento de 1 ano
title_full Efetividade e custo-efetividade de três alternativas de tratamento para reabilitação do desdentado mandibular: ensaio clínico randomizado com acompanhamento de 1 ano
title_fullStr Efetividade e custo-efetividade de três alternativas de tratamento para reabilitação do desdentado mandibular: ensaio clínico randomizado com acompanhamento de 1 ano
title_full_unstemmed Efetividade e custo-efetividade de três alternativas de tratamento para reabilitação do desdentado mandibular: ensaio clínico randomizado com acompanhamento de 1 ano
title_sort Efetividade e custo-efetividade de três alternativas de tratamento para reabilitação do desdentado mandibular: ensaio clínico randomizado com acompanhamento de 1 ano
author Hartmann, Roberto
author_facet Hartmann, Roberto
author_role author
dc.contributor.advisor1.fl_str_mv Leles, Cláudio Rodrigues
dc.contributor.advisor1Lattes.fl_str_mv http://lattes.cnpq.br/6740286066154410
dc.contributor.advisor-co1.fl_str_mv Schimmel, Martin
dc.contributor.referee1.fl_str_mv Leles, Cláudio Rodrigues
dc.contributor.referee2.fl_str_mv Gonçalves, Thais Marques Simek Vega
dc.contributor.referee3.fl_str_mv Abreu, Mauro Henrique Nogueira Guimarães de
dc.contributor.referee4.fl_str_mv Ribeiro-Rotta, Rejane Faria
dc.contributor.referee5.fl_str_mv Nogueira, Túlio Eduardo
dc.contributor.authorLattes.fl_str_mv http://lattes.cnpq.br/5981857085438577
dc.contributor.author.fl_str_mv Hartmann, Roberto
contributor_str_mv Leles, Cláudio Rodrigues
Schimmel, Martin
Leles, Cláudio Rodrigues
Gonçalves, Thais Marques Simek Vega
Abreu, Mauro Henrique Nogueira Guimarães de
Ribeiro-Rotta, Rejane Faria
Nogueira, Túlio Eduardo
dc.subject.por.fl_str_mv Implante dentário
Prótese dentária
Ensaio clínico randomizado
Análise de custo-efetividade
Desfechos de tratamento dental
topic Implante dentário
Prótese dentária
Ensaio clínico randomizado
Análise de custo-efetividade
Desfechos de tratamento dental
Prosthodontics
Randomized clinical trial
Cost-effectiveness analysis
Treatment outcomes
Implant
CIENCIAS DA SAUDE::ODONTOLOGIA
dc.subject.eng.fl_str_mv Prosthodontics
Randomized clinical trial
Cost-effectiveness analysis
Treatment outcomes
Implant
dc.subject.cnpq.fl_str_mv CIENCIAS DA SAUDE::ODONTOLOGIA
description This randomized trial compared the effectiveness and cost-effectiveness (cost x patient centered outcomes) of three treatment alternatives for mandibular edentulism rehabilitation: unit-implant-retained mandibular overdenture (Group I), two-implant-retained mandibular overdenture (Group II) and four-implant-supported mandibular fixed prosthesis (Group III). We included 50 fully edentulous patients who initially received new conventional total dentures (baseline) and were later randomly allocated to one of the treatment groups. External hexagon implants (Titamax TI Cortical, Neodent, Curitiba, Brazil) were installed following the conventional loading installation protocol. Generalized Estimating Equations (GEE) was used to calculate the primary outcome variables were the direct dental costs which were identified, measured and valued; oral health-related quality of life (OHIP-Edent) and patient satisfaction with prostheses in all groups for a follow-up period of 1 year. Masticatory performance, prosthetic complications, maintenance events and peri-implant evaluation (marginal bone loss, peri-implant tissue status, implant stability quotient - ISQ) were evaluated as secondary outcomes. Data from 37 participants: Group I (n = 11); Group II (n = 13); Group III (n = 13) were collected and were similar in relation to baseline clinical characteristics and outcomes of initial treatment with conventional full dentures. Incremental cost-effectiveness - ICER ranged for Group II (compared to Group I) from R$ 36.20 to R$ 81.46 for a 1-point increase in patient satisfaction (base value = R$ 54.30) for Group III (compared to Group I) ranged from R$ 1321.12 to R$ 2972.52 (base value = R$ 1981.68). The total cost of treatment for the surgical and prosthetic phases was R$ 2,370.70 for Group I, R$ 3,185.20 for Group II and R$ 5,739.50 for Group III. There was a significant difference between the costs in the three groups (p <0.001). The greatest impacts on total treatment cost were related to the initial laboratory, implant and component costs in Group III. The satisfaction questionnaires and OHIP-Edent satisfaction scores in the 12 months improved in all groups compared to baseline. and were similar in intergroup comparison at baseline (with new conventional full dentures) and 1 year after implant prosthesis capture. In intra- and inter-group comparisons there was no significant change regarding satisfaction with the maxillary prosthesis. Regarding masticatory performance, there was no difference between groups evaluated in the same period for the different cycles (20 and 50 cycles) with gradual improvement for all groups up to 6 months and a slight decrease in 12 months for all groups. It was concluded that the rehabilitation of edentulous patients with implants significantly improved patient-reported outcomes in all treatment groups. Regarding the economic aspects of the treatments, the direct dental cost and the clinical time spent to perform the treatment and follow-up during the 1 year period in the fixed prosthesis (Group III) was approximately three times higher than in Group I, which did not correspond to a proportional gain in effectiveness as well as the additional cost of overdenture retained by two implants did not result in significant effectiveness gain over overdenture retained per unit implant. The implant survival was 100% in all groups after the 1-year follow-up. Considering the limitations of the study, implant-retained overdentures were the most cost-effective modalities.
publishDate 2019
dc.date.accessioned.fl_str_mv 2019-11-11T15:24:08Z
dc.date.issued.fl_str_mv 2019-08-23
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/doctoralThesis
format doctoralThesis
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dc.identifier.citation.fl_str_mv HARTMANN, R. Efetividade e custo-efetividade de três alternativas de tratamento para reabilitação do desdentado mandibular: ensaio clínico randomizado com acompanhamento de 1 ano. 2019. 102 f. Tese (Doutorado em Odontologia) - Universidade Federal de Goiás, Goiânia, 2019.
dc.identifier.uri.fl_str_mv http://repositorio.bc.ufg.br/tede/handle/tede/10168
identifier_str_mv HARTMANN, R. Efetividade e custo-efetividade de três alternativas de tratamento para reabilitação do desdentado mandibular: ensaio clínico randomizado com acompanhamento de 1 ano. 2019. 102 f. Tese (Doutorado em Odontologia) - Universidade Federal de Goiás, Goiânia, 2019.
url http://repositorio.bc.ufg.br/tede/handle/tede/10168
dc.language.iso.fl_str_mv eng
language eng
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600
600
600
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dc.relation.cnpq.fl_str_mv -2070498469879244349
dc.relation.sponsorship.fl_str_mv 2075167498588264571
dc.rights.driver.fl_str_mv http://creativecommons.org/licenses/by-nc-nd/4.0/
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rights_invalid_str_mv http://creativecommons.org/licenses/by-nc-nd/4.0/
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dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Universidade Federal de Goiás
dc.publisher.program.fl_str_mv Programa de Pós-graduação em Odontologia (FO)
dc.publisher.initials.fl_str_mv UFG
dc.publisher.country.fl_str_mv Brasil
dc.publisher.department.fl_str_mv Faculdade de Odontologia - FO (RG)
publisher.none.fl_str_mv Universidade Federal de Goiás
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